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Weight Loss Patent Abstract
Methods for achieving weight loss goals and maintaining weight loss
including selecting an appropriate weight loss program that provides
a caloric deficit of not more than 350 kilocalories per day, and
concurrently ingesting a composition comprising effective amounts
of a combination of an anionic soluble fiber and a multivalent cation
source during the weight loss program. Also, a method for producing
weight loss including identifying an individual in need, providing
the individual a weight loss program that provides a caloric deficit
of not more than 350 kilocalories per day, and directing the individual
to ingest a composition comprising an effective amount of a combination
of anionic soluble fiber and a multivalent cation.
Weight Loss Patent Claims
1. A method for reducing weight in an individual comprising adhering
to a weight loss program that provides a caloric deficit of not
more than about 350 kilocalories per day, and concurrently ingesting
a composition comprising effective amounts of a combination of an
anionic soluble fiber and a multivalent cation source during the
weight loss program.
2. A method for reducing weight of claim 1 wherein the caloric
deficit is achieved by reducing food intake, in comparison to the
food intake prior to beginning the weight loss program.
3. A method for reducing weight of claim 2, wherein the caloric
deficit is from about 120 to about 350 kilocalories per day.
4. A method for reducing weight of claim 3, wherein the caloric
deficit is from about 150 to about 300 kilocalories per day.
5. A method for reducing weight of claim 4, wherein the caloric
deficit if from about 160 to about 270 kilocalories per day.
6. A method for reducing weight of claim 1, wherein the individual
has previously completed a weight loss program comprising an exercise
component and a counseling component.
7. A method for reducing weight of claim 6, wherein the previous
weight loss program comprising an exercise component and a counseling
component was completed within 30 days of starting the weight loss
program.
8. A method for reducing weight of claim 1 wherein the comestible
product contains an anionic soluble fiber and a multivalent cation
source.
9. A method for reducing weight of claim 8 wherein the anionic
soluble fiber is alginate.
10. A method for reducing weight of claim 8 wherein the multivalent
cation source is selected from the group consisting of calcium,
magnesium, aluminum, manganese, iron, nickel, copper, zinc, strontium,
barium, bismuth, chromium, vanadium, and lanthanum, their salts,
and mixtures thereof.
11. A method of reducing weight of claim 10 wherein the multivalent
cation salt is selected from the group consisting of formate, fumarate,
acetate, propionate, butyrate, caprylate, valerate, lactate, citrate,
malate and gluconate, chloride, phosphate and mixtures thereof.
12. A method for reducing weight of claim 10, wherein the multivalent
cation is calcium and wherein the salt is selected from the group
consisting of calcium citrate, calcium tartrate, calcium succinate,
calcium fumarate, calcium adipate, calcium malate, calcium lactate,
calcium gluconate, dicalcium phosphate dihydrate, anhydrous calcium
diphosphate, dicalcium phosphate anhydrous, calcium chloride, calcium
acetate monohydrate, and mixtures thereof.
13. A method for reducing weight of claim 8, wherein a ratio of
the soluble anionic fiber to the multivalent cation in the comestible
product is from about 20:1 to 7:1.
14. A method of claim 1 for reducing weight, wherein the amount
of soluble anionic fiber is from about 1.5 grams to about 6 grams.
15. A method for reducing weight of claim 1, wherein the ingestible
composition contains from about 50 kilocalories to 150 kilocalories.
16. A method for reducing weight of claim 1, wherein the ingestible
composition is selected from a formed solid, a fluid, and a combination
thereof.
17. A method for reducing weight loss of claim 1, wherein the weight
loss program comprises low intensity counseling.
18. A method of claim 1 wherein the composition comprising effective
amounts of a combination of an anionic soluble fiber and a multivalent
cation source is consumed about twice per day during the weight
loss program.
19. A method for producing weight loss in an individual, the method
comprising identifying an individual desiring or in need of weight
loss, providing to the individual a weight loss program that provides
a caloric deficit of not more than about 300 kilocalories per day,
and directing the individual during the weight loss program to ingest
a composition comprising an effective amount of a combination of
an anionic soluble fiber and a multivalent cation.
20. A method for producing weight loss of claim 19 wherein the
caloric deficit is achieved by reducing food intake, in comparison
to the food intake prior to beginning the weight loss program.
21. A method for producing weight loss of claim 19, wherein the
caloric deficit is from about 120 to about 350 kilocalories per
day.
22. A method for producing weight loss of claim 21, wherein the
caloric deficit is from about 150 to about 300 kilocalories per
day.
23. A method for producing weight loss of claim 22, wherein the
caloric deficit if from about 160 to about 270 kilocalories per
day.
24. A method for producing weight loss of claim 19, wherein the
individual has previously completed a weight loss program comprising
an exercise component and a counseling component.
25. A method for producing weight loss of claim 19, wherein the
weight loss program comprises low intensity counseling.
Weight Loss Patent Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application is a continuation-in-part application of
copending U.S. patent application Ser. No. 11/245,762, filed Oct.
7, 2005.
FIELD OF THE INVENTION
[0002] The present invention is directed to a method for achieving
weight loss and maintaining weight loss.
BACKGROUND OF THE INVENTION
[0003] Diabetes and obesity are common ailments in the United States
and other Western cultures. A study by researchers at RTI International
and the Centers for Disease Control estimated that U.S. obesity-attributable
medical expenditures reached $75 billion in 2003. Obesity has been
shown to promote many chronic diseases, including type 2 diabetes,
cardiovascular disease, several types of cancer, and gallbladder
disease.
[0004] Adequate dietary intake of soluble fiber has been associated
with a number of health benefits, including decreased blood cholesterol
levels, improved glycemic control, and the induction of satiety
and satiation in individuals. Consumers have been resistant to increasing
soluble fiber amounts in their diet, however, often due to the negative
organoleptic characteristics, such as, sliminess, excessive viscosity,
excessive dryness and poor flavor, that are associated with food
products that include soluble fiber.
[0005] What is needed are weight loss methods and weight maintenance
using, among other things, ingestible compositions having fibers
and cations.
SUMMARY OF THE INVENTION
[0006] The present invention solves those needs. One embodiment
of the present invention is directed to a method for achieving weight
loss goals and maintaining weight loss comprising, consisting of,
and/or consisting essentially of the steps of first, selecting an
appropriate weight loss program and identifying a weight loss goal;
followed by, second, participating in the weight loss program until
the weight loss goal is achieved; third, ending the weight loss
program participation; and fourth, consuming an ingestible composition
at regular intervals beginning from about 1 to about 48 hours after
ending the weight loss program, the ingestible composition comprising
an effective amount of a multivalent cation and an effective amount
of an soluble anionic fiber.
[0007] Another embodiment of the present invention is directed
to a method for achieving and maintaining weight loss comprising,
consisting of, and/or consisting essentially of the steps of first,
selecting an appropriate weight loss program and identifying a weight
loss goal of at least 5% of total body weight, followed by participating
in the weight loss program until the weight loss goal is achieved;
ending the weight loss program participation; and consuming an ingestible
composition comprising a solid component and a fluid component at
regular intervals between breakfast and lunch, lunch and dinner,
or both, beginning from about 1 to about 48 hours after ending the
weight loss program, the ingestible composition comprising, consisting
of, and/or consisting essentially of an effective amount of a calcium
source in the fluid component and from bout 0.5 g to about 10 g
total soluble anionic fiber per serving wherein the soluble anionic
fiber is a mixture of alginate and pectin in the solid component.
[0008] Yet another embodiment of the present invention is directed
to a method for achieving and maintaining weight comprising, consisting
of, and/or consisting essentially of the steps of engaging in a
weight loss program that involves low intensity counseling, reducing
daily caloric intake below maintenance levels by less than 500 kilocalories
per day, and consuming during the weight loss program an ingestible
composition comprising, consisting of, and/or consisting essentially
of a weight loss promoting effective amount of a combination of
soluble anionic fiber and a divalent cation source.
BRIEF DESCRIPTION OF DRAWINGS
[0009] FIG. 1 is a graph depicting the effects of an embodiment
of the present invention on intestinal viscosity.
DETAILED DESCRIPTION OF THE INVENTION
[0010] As used herein, unless indicated otherwise, the terms "alginate,"
"pectin," "carrageenan," "polygeenan,"
or "gellan" refers to all forms (e.g., protonated or salt
forms, such as sodium, potassium, and ammonium salt forms and having
varying average molecular weight ranges) of the soluble anionic
fiber type.
[0011] As used herein, unless indicated otherwise, the term "alginic
acid" includes not only the material in protonated form but
also the related salts of alginate, including but not limited to
sodium, potassium, and ammonium alginate.
[0012] As used herein, unless indicated otherwise, the term "protected"
means that the source has been treated in such a way, as illustrated
below, to delay (e.g., until during or after ingestion or until
a certain pH range has been reached) reaction of the at least one
multivalent cation with the soluble anionic fiber as compared to
an unprotected multivalent cation.
[0013] As used herein, unless indicated otherwise, the term SE
or Satiety Efficiency Index means, unless otherwise defined, caloric
reduction in a given meal due to preload divided by the caloric
value of the preload. For example, if a person consumes a 1000 calorie
lunch without ingesting a preload, but consumes a 900 calorie lunch
after ingesting a 200 calorie preload, the preload would have a
0.50 or 50% SE. Another example is a person consumes a 1000 calorie
lunch without ingesting a preload, but consumes a 800 calorie lunch
after ingesting a 100 calorie preload, the preload would have a
2.0 or 200% SE. As can be seen, the greater the SE, the greater
the effect of the preload on the next meal.
[0014] As used herein, unless indicated otherwise, the term "low
intensity counseling" means counseling, in the context of a
weight loss or weight maintenance program, that comprises maintaining,
under the auspices of a counselor or health care professional, food
intake or caloric intake diaries, recording physical activity in
the same or separate diaries, recording the steps taken with a pedometer
or a similar device, reviewing these data on a periodic basis with
a health care professional or a weight loss counselor, and being
weighed on a periodic basis by such professional or counselor to
ascertain progress. In the context of low intensity counseling,
the periodic review of data and weighing may occur at intervals
of about once per week to about once per quarter, more preferably
every two to six week, and most preferably monthly.
[0015] As used herein, unless indicated otherwise, the term "caloric
deficit" is, in a person undergoing weight loss, the difference
in the number of calories of energy actually consumed, versus the
number of calories that would have to be consumed to maintain a
stable weight. For example, an individual might require 2000 kcal
of energy intake per day to maintain stable weight at a fixed level
of physical activity. During a weight loss program, this same individual
might consume 1700 kcal per day, while maintaining the same fixed
level of physical activity. In this example, the daily caloric deficit
would be 300 kcal. A caloric deficit can also be achieved by maintaining
a constant daily energy intake (as measured by kcal of energy ingested)
but increasing caloric expenditure through physical activity. Caloric
deficit may be determined by measuring the mass units of weight
loss of an individual over an interval of time, multiplying the
mass of weight loss by the caloric content of a unit of body mass
in an overweight or obese individual, and dividing that product
by the units of time in the interval. For example, assume that an
individual lost two kg over an eight-week interval. Assuming that
each kilogram of lost weight was equivalent to 8000 kcal, then the
caloric deficit was 16,000 kcal over 56 days, or the caloric deficit
of 286 kcal per day.
[0016] Unless otherwise defined, all technical and scientific terms
used herein have the same meaning as commonly understood by one
of ordinary skill in the art to which this invention pertains. Although
methods and materials similar or equivalent to those described herein
can be used in the practice or testing of the present invention,
suitable methods and materials are described below. All publications,
patent applications, patents, and other references mentioned herein
are incorporated by reference in their entirety. In case of conflict,
the present specification, including definitions, will control.
In addition, the materials, methods, and examples are illustrative
only and not intended to be limiting.
[0017] As used herein, a recitation of a range of values is merely
intended to serve as a shorthand method of referring individually
to each separate value falling within the range, and each separate
value is incorporated into the specification as if it were individually
recited herein.
[0018] The inventors were surprised to discover that the compositions
of this invention reduce food intake at consumption levels of dietary
fiber much lower than the levels that have previously been reported
to reduce food intake. The inventors believe that this arises from
the enhanced viscosity produced by the interactions of soluble multivalent
cation and at least one soluble anionic fiber.
Soluble Anionic Fiber
[0019] Any soluble anionic fiber should be acceptable for the purposes
of this invention. Suitable soluble anionic fibers include alginate,
pectin, gellan, soluble fibers that contain carboxylate substituents,
carrageenan, polygeenan, and marine algae-derived polymers that
contain sulfate substituents.
[0020] Also included within the scope of soluble anionic fibers
are other plant derived and synthetic or semisynthetic polymers
that contain sufficient carboxylate, sulfate, or other anionic moieties
to undergo gelling in the presence of sufficient levels of multivalent
cation.
[0021] At least one source of soluble anionic fiber may be used
in these compositions, and the at least one source of soluble anionic
fiber may be combined with at least one source of soluble fiber
that is uncharged at neutral pH. Thus, in certain cases, two or
more soluble anionic fibers types are included, such as, alginate
and pectin, alginate and gellan, or pectin and gellan. In other
cases, only one type of soluble anionic fiber is used, such as only
alginate, only pectin, only carrageenan, or only gellan.
[0022] Soluble anionic fibers are commercially available, e.g.,
from ISP (Wayne, N.J.), TIC Gums, and CP Kelco.
[0023] An alginate can be a high guluronic acid alginate. For example,
in certain cases, an alginate can exhibit a higher than 1:1 ratio
of guluronic to mannuronic acids, such as in the range from about
1.2:1 to about 1.8:1, e.g., about 1.3:1, about 1.4:1, about 1.5:1,
about 1.6:1, or about 1.7:1 or any value therebetween. Examples
of high guluronic alginates (e.g., having a higher than 1:1 g:m
ratios) include Manugel LBA, Manugel GHB, and Manugel DBP, which
each have a g:m ratio of about 1.5.
[0024] While not being bound by theory, it is believed that high
guluronic alginates can cross-link through multivalent cations,
e.g., calcium ions, to form gels at the low pH regimes in the stomach.
High guluronic alginates are also believed to electrostatically
associate with pectins and/or gellans at low pHs, leading to gellation.
In such cases, it may be useful to delay the introduction of multivalent
cations until after formation of the mixed alginate/pectin or alginate/gellan
gel, as multivalent cationic cross-links may stabilize the mixed
gel after formation.
[0025] In other cases, an alginate can exhibit a ratio of guluronic
to mannuronic acids (g:m ratio) of less than about 1:1, e.g., about
0.8:1 to about 0.4:1, such as about 0.5:1, about 0.6:1, or about
0.7:1 or any value therebetween. Keltone LV and Keltone HV are examples
of high-mannuronic acids (e.g., having a g:m ratio of less than
1:1) having g:m ratios ranging from about 0.6:1 to about 0.7:1.
[0026] Methods for measuring the ratio of guluronic acids to mannuronic
acids are known by those having ordinary skill in the art.
[0027] An alginate can exhibit any number average molecular weight
range, such as a high molecular weight range (about 2.05.times.10.sup.5
to about 3.times.10.sup.5 Daltons or any value therebetween; examples
include Manugel DPB, Keltone HV, and TIC 900 Alginate); a medium
molecular weight range (about 1.38.times.10.sup.5 to about 2.times.10.sup.5
Daltons or any value therebetween; examples include Manugel GHB);
or a low molecular weight range (about 2.times.10.sup.4 to about
1.35.times.10.sup.5 Daltons or any value therebetween; examples
include Manugel LBA and Manugel LBB). Number average molecular weights
can be determined by those having ordinary skill in the art, e.g.,
using size exclusion chromatography (SEC) combined with refractive
index (RI) and multi-angle laser light scattering (MALLS).
[0028] In certain embodiments of a formed food product, a low molecular
weight alginate can be used (e.g., Manugel LBA), while in other
cases a mixture of low molecular weight (e.g., Manugel LBA) and
high molecular weight (e.g., Manugel DPB, Keltone HV) alginates
can be used. In other cases, a mixture of low molecular weight (e.g.,
Manugel LBA) and medium molecular weight (e.g., Manugel GHB) alginates
can be used. In yet other cases, one or more high molecular weight
alginates can be used (e.g., Keltone HV, Manugel DPB).
[0029] A pectin can be a high-methoxy pectin (e.g., having greater
than 50% esterified carboxylates), such as ISP HM70LV and CP Kelco
USPL200. A pectin can exhibit any number average molecular weight
range, including a low molecular weight range (about 1.times.10.sup.5
to about 1.20.times.10.sup.5 Daltons, e.g., CP Kelco USPL200), medium
molecular weight range (about 1.25.times.10.sup.5 to about 1.45.times.10.sup.5,
e.g., ISP HM70LV), or high molecular weight range (about 1.50.times.10.sup.5
to about 1.80.times.10.sup.5, e.g., TIC HM Pectin). In certain cases,
a high-methoxy pectin can be obtained from pulp, e.g., as a by-product
of orange juice processing.
[0030] A gellan soluble anionic fiber can also be used. Gellan
fibers form strong gels at lower concentrations than alginates and/or
pectins, and can cross-link with multivalent cation cations. For
example, gellan can form gels with sodium, potassium, magnesium,
and calcium. Gellans for use in the invention include Kelcogel,
available commercially from CP Kelco.
[0031] Fiber blends as described herein can also be used in the
preparation of a solid ingestible composition like a formed food
product where the fiber blend is a source of the soluble anionic
fiber. A useful fiber blend can include an alginate soluble anionic
fiber and a pectin soluble anionic fiber. A ratio of total alginate
to total pectin in a blend can be from about 8:1 to about 5:1, or
any value therebetween, such as about 7:1, about 6.5:1, about 6.2:1,
or about 6.15:1. A ratio of a medium molecular weight alginate to
a low molecular weight alginate can range from about 0.65:1 to about
2:1, or any value therebetween.
[0032] An alginate soluble anionic fiber in a blend can be a mixture
of two or more alginate forms, e.g., a medium and low molecular
weight alginate. In certain cases, a ratio of a medium molecular
weight alginate to a low molecular weight alginate is about 0.8:1
to about 0.9:1. The fiber blend combining low and medium molecular
weight alginates with high methoxy pectin can be from about 0 to
about 3 grams. The preferred range for both would be about 1 to
about 2 grams.
[0033] The at least one soluble anionic fiber may be treated before,
during, or after incorporation into an ingestible composition. For
example, the at least one soluble anionic fiber can be processed,
e.g., extruded, roll-dried, freeze-dried, dry blended, roll-blended,
agglomerated, coated, or spray-dried.
[0034] For solid forms, a variety of formed shapes of food products
can be prepared by methods known to those having ordinary skill
in the art, extruding, molding, pressing, wire-cutting. For example,
a single or double screw extruder can be used. Typically, a feeder
meters in the raw ingredients to a barrel that includes the screw(s).
The screw(s) conveys the raw material through the die that shapes
the final product. Extrusion can take place under high temperatures
and pressures or can be a non-cooking, forming process. Extruders
are commercially available, e.g., from Buhler, Germany. Extrusion
can be cold or hot extrusion.
[0035] Other processing methods are known to those having skilled
in the art.
[0036] The amount of the at least one soluble anionic fiber included
can vary, and will depend on the type of ingestible composition
and the type of soluble anionic fiber used. For example, typically
a solid ingestible composition will include from about 0.5 g to
about 10 g total soluble anionic fiber per serving or any value
therebetween. A preferred range of fiber intake in the compositions
of this invention is about 0.25 g to about 5 g per serving, more
preferably about 0.5 to about 3 g per serving, and most preferably
about 1.0 to about 2.0 g per serving. In certain cases, a formed
food product can include a soluble anionic fiber at a total amount
from about 22% to about 40% by weight of the formed product or any
value therebetween. In other cases, a formed food product can include
an soluble anionic fiber in a total amount of from about 4% to about
15% or any value therebetween, such as when only gellan is used.
In yet other cases, a formed food product can include a soluble
anionic fiber at a total amount of from about 18% to about 25% by
weight, for example, when combinations of gellan and alginate or
gellan and pectin are used.
[0037] In addition to the at least one soluble anionic fiber, a
solid ingestible composition can include ingredients that may be
treated in a similar manner as the at least one soluble anionic
fiber. For example, such ingredient can be co-extruded with the
soluble anionic fiber, co-processed with the soluble anionic fiber,
or co-spray-dried with the soluble anionic fiber. Such treatment
can help to reduce sliminess of the ingestible composition in the
mouth and to aid in hydration and gellation of the fibers in the
stomach and/or small intestine. Without being bound by any theory,
it is believed that co-treatment of the soluble anionic fiber(s)
with such ingredient prevents early gellation and hydration of the
fibers in the mouth, leading to sliminess and unpalatability. In
addition, co-treatment may delay hydration and subsequent gellation
of the soluble anionic fibers (either with other soluble anionic
fibers or with multivalent cations) until the ingestible composition
reaches the stomach and/or small intestine, providing for the induction
of satiety and/or satiation.
[0038] Additional ingredients can be hydrophilic in nature, such
as starch, protein, maltodextrin, and inulin. Other additional ingredients
can be insoluble in water (e.g., cocoa solids, corn fiber) and/or
fat soluble (vegetable oil), or can be flavor modifiers such as
sucralose. For example, a formed food product can include from about
5 to about 80% of a cereal ingredient, such as about 40% to about
68% of a cereal ingredient. A cereal ingredient can be rice, corn,
wheat, sorghum, oat, or barley grains, flours, or meals. Thus, a
formed food product can include about 40% to about 50%, about 50%
to about 58%, about 52% to about 57%, or about 52%, about 53%, about
54%, about 55%, about 56%, or about 56.5% of a cereal ingredient.
In one embodiment, about 56.5% of rice flour is included.
[0039] An ingestible composition can also include a protein source.
A protein source can be included in the composition or in a formed
food product. For example, a formed food product can include a protein
source at about 2% to about 20% by weight, such as about 3% to about
8%, about 3% to about 5%, about 4% to about 7%, about 4% to about
6%, about 5% to about 7%, about 5% to about 15%, about 10% to about
18%, about 15% to about 20%, or about 8% to about 18% by weight.
A protein can be any known to those having ordinary skill in the
art, e.g., rice, milk, egg, wheat, whey, soy, gluten, or soy flour.
In some cases, a protein source can be a concentrate or isolate
form.
Multivalent Cation
[0040] The compositions and associated methods of this invention
include a source of at least one multivalent cation in an amount
sufficient to cause an increase in viscosity of the soluble anionic
fiber. A source of at least one multivalent cation may be incorporated
into an ingestible composition provided herein, or can consumed
as a separate food article either before, after, or simultaneously
with an ingestible composition.
[0041] Any multivalent cation may be used in the present invention,
e.g., multivalent, trivalent, and the like. Multivalent cations
useful in this invention include, calcium, magnesium, aluminum,
manganese, iron, nickel, copper, zinc, strontium, barium, bismuth,
chromium, vanadium, lanthanum, their salts and mixtures thereof.
Salts of the multivalent cations may be organic acid salts that
include formate, fumarate, acetate, propionate, butyrate, caprylate,
valerate, lactate, citrate, malate and gluconate. Also included
are highly soluble inorganic salts such as chlorides or other halide
salts.
[0042] In certain compositions, one or more particular multivalent
cations may be used with certain soluble anionic fibers, depending
on the composition and gel strength desired. For example, for ingestible
alginate compositions, calcium may be used to promote gellation.
For gellan compositions, one or more of calcium and magnesium may
be used.
[0043] The at least one multivalent cation can be unable to, or
be limited in its ability to, react with the at least one soluble
anionic fiber in the ingestible composition until during or after
ingestion. For example, physical separation of the at least one
multivalent cation from the at least one soluble anionic fiber,
e.g., as a separate food article or in a separate matrix of the
ingestible composition from the at least one soluble anionic fiber,
can be used to limit at least one multivalent cation's ability to
react. In other cases, the at least one multivalent cation is limited
in its ability to react with the at least one soluble anionic fiber
by protecting the source of at least one multivalent cation until
during or after ingestion. Thus, the at least one multivalent cation,
such as, a protected multivalent cation, can be included in the
ingestible composition or can be included as a separate food article
composition, e.g., for separate ingestion either before, during,
or after ingestion of an ingestible composition.
[0044] Typically, a separate food article containing the source
of at least one multivalent cation would be consumed in an about
four hour time window flanking the ingestion of an ingestible composition
containing the at least one soluble anionic fiber. In certain cases,
the window may be about three hours, or about two hours, or about
one hour. In other cases, the separate food article may be consumed
immediately before or immediately after ingestion of an ingestible
composition, e.g., within about fifteen minutes, such as within
about 10 minutes, about 5 minutes, or about 2 minutes. In other
cases, a separate food article containing at least one multivalent
cation can be ingested simultaneously with an ingestible composition
containing the at least one soluble anionic fiber, e.g., a snack
chip composition where some chips include at least one multivalent
cation and some chips include the at least one soluble anionic fiber.
[0045] In one embodiment, at least one multivalent cation can be
included in an ingestible composition in a different food matrix
from a matrix containing a soluble anionic fiber. For example, a
source of at least one multivalent cation, such as a calcium salt,
can be included in a separate matrix of a solid ingestible composition
from the matrix containing the at least one soluble anionic fiber.
Thus, means for physical separation of an soluble anionic fiber
(e.g., within a snack bar or other formed food product) from a source
of at least one multivalent cation are also contemplated, such as
by including the source of at least one multivalent cation in a
matrix such as a frosting, water and fat based icing, coating, decorative
topping, drizzle, chip, chunk, swirl, filling, or interior layer.
In one embodiment, a source of at least one multivalent cation,
such as a protected multivalent cation source, can be included in
a snack bar matrix that also contains an extruded crispy matrix
that contains the soluble anionic fiber. In such a case, the source
of at least one multivalent cation is in a separate matrix than
the crispy matrix containing the soluble anionic fiber. In another
embodiment, a source of at least one multivalent cation can be included
in a gel layer or phase, e.g., a jelly or jam.
[0046] One multivalent cation source is multivalent cation salts.
Typically, a multivalent cation salt can be selected from the following
salts: citrate, tartrate, malate, formate, lactate, gluconate, phosphate,
carbonate, sulfate, chloride, acetate, propionate, butyrate, caprylate,
valerate, fumarate, adipate, and succinate. In certain cases, a
multivalent cation salt is a calcium salt. A calcium salt can have
a solubility of >1% w/vol in water at pH 7 at 20.degree. C. A
calcium salt can be, without limitation, calcium citrate, calcium
tartrate, calcium malate, calcium lactate, calcium gluconate, dicalcium
phosphate dihydrate, anhydrous calcium diphosphate, dicalcium phosphate
anhydrous, calcium carbonate, calcium sulfate dihydrate, calcium
sulfate anhydrous, calcium chloride, calcium acetate monohydrate,
monocalcium phosphate monohydrate, and monocalcium phosphate anhydrous.
[0047] The source of at least one multivalent cation can be a protected
source.
[0048] A number of methods can be used to protect a source of at
least one multivalent cation. For example, microparticles or nanoparticles
having double or multiple emulsions, such as water/oil/water ("w/o/w")
or oil/water/oil ("o/w/o") emulsions, of at least one
multivalent cation and an soluble anionic fiber can be used. In
one embodiment, a calcium alginate microparticle or nanoparticle
is used. For example, a calcium chloride solution can be emulsified
in oil, which emulsion can then be dispersed in a continuous water
phase containing the anionic alginate soluble fiber. When the emulsion
breaks in the stomach, the calcium can react with the alginate to
form a gel.
[0049] A microparticle can have a size from about 1 to about 15
.mu.M (e.g., about 5 to about 10 .mu.M, or about 3 to about 8 .mu.M).
A nanoparticle can have a size of about 11 to about 85 nm (e.g.,
about 15 to about 50 nm, about 30 to about 80 nm, or about 50 to
about 75 nm). The preparation of multiple or double emulsions, including
the choice of surfactants and lipids, is known to those having ordinary
skill in the art.
[0050] In another embodiment, nanoparticles of calcium alginate
are formed by preparing nanodroplet w/o microemulsions of CaCl.sub.2
in a solvent and nanodroplet w/o microemulsions of alginate in the
same solvent. When the two microemulsions are mixed, nanoparticles
of calcium alginate are formed. The particles can be collected and
dispersed, e.g., in a fluid ingestible composition. As the particle
size is small (<100 nm), the particles stay dispersed (e.g.,
by Brownian motion), or can be stabilized with a food grade surfactant.
Upon ingestion, the particles aggregate and gel.
[0051] In other embodiments, a liposome containing a source of
at least one multivalent cation can be included in an ingestible
composition. For example, a calcium-containing liposome can be used.
The preparation of liposomes containing multivalent cations is well
known to those having ordinary skill in the art; see ACS Symposium
Series, 1998 709:203-211; Chem. Mater. 1998 (109-116). Cochelates
can also be used, e.g., as described in U.S. Pat. No. 6,592,894
and U.S. Pat. No. 6,153,217. The creation of cochelates using multivalent
cations such as calcium can protect the multivalent cations from
reacting with the soluble anionic fiber within the aqueous phase
of an ingestible composition, e.g., by wrapping the multivalent
cations in a hydrophobic lipid layer, thus delaying reaction with
the fiber until digestion of the protective lipids in the stomach
and/or small intestine via the action of lipases.
[0052] In certain cases, a multivalent cation-containing carbohydrate
glass can be used, such as a calcium containing carbohydrate glass.
A carbohydrate glass can be formed from any carbohydrate such as,
without limitation, sucrose, trehalose, inulin, maltodextrin, corn
syrup, fructose, dextrose, and other mono-, di-, or oligo-saccharides
using methods known to those having ordinary skill in the art; see,
e.g., WO 02/05667. A carbohydrate glass can be used, e.g., in a
coating or within a food matrix.
Ingestible Compositions
[0053] Compositions of the present invention can be in any form,
fluid or solid. Fluids can be beverages, including shake, liquado,
and smoothie. Fluids can be from low to high viscosity.
[0054] Solid forms ca formed or not. Solid forms may include bread,
cracker, bar, mini-bars, cookie, confectioneries, e.g., nougats,
toffees, fudge, caramels, hard candy enrobed soft core, muffins,
cookies, brownies, cereals, chips, snack foods, bagels, chews, crispies,
and nougats, pudding, jelly, and jam. Solids can have densities
from low to high.
Fluids
[0055] Fluid ingestible compositions can be useful for, among other
things, aiding in weight loss programs, e.g., as meal replacement
beverages or diet drinks. Fluid ingestible compositions can provide
from about 0.5 g to about 10 g of soluble anionic fiber per serving,
or any value therebetween. For example, in certain cases, about
1 g, 2 g, 3 g, 4 g, 5 g, 6 g, 7 g, 8 g, or 9 g of at least one soluble
anionic fiber are provided per serving.
[0056] A fluid ingestible composition may include an alginate soluble
anionic fiber and/or a pectin soluble anionic fiber. In certain
cases, an alginate soluble anionic fiber and a pectin soluble anionic
fiber are used. A fiber blend as described herein can be used to
provide the alginate soluble anionic fiber and/or the pectin soluble
anionic fiber. An alginate and pectin can be any type and in any
form, as described previously. For example, an alginate can be a
high, medium, or low molecular weight range alginate, and a pectin
can be a high-methoxy pectin. Also as indicated previously, two
or more alginate forms can be used, such as a high molecular weight
and a low molecular weight alginate, or two high molecular weight
alginates, or two low molecular weight alginates, or a low and a
medium molecular weight alginate, etc. For example, Manugel GHB
alginate and/or Manugel LBA alginate can be used. In other cases,
Manugel DPB can be used. Genu Pectin, USPL200 (a high-methoxy pectin)
can be used as a pectin. In certain cases, potassium salt forms
of an soluble anionic fiber can be used, e.g., to reduce the sodium
content of an ingestible composition.
[0057] A fluid ingestible composition includes alginate and/or
pectin in a total amount of about 0.3% to about 5% by weight, or
any value therebetween, e.g., about 1.25% to about 1.9%; about 1.4%
to about 1.8%; about 1.0% to about 2.2%, about 2.0% to about 4.0%,
about 3.0%, about 4.0%, about 2.0%, about 1.5%, or about 1.5% to
about 1.7%. Such percentages of total alginate and pectin can yield
about 2 g to about 8 g of fiber per 8 oz. serving, e.g., about 3
g, about 4 g, about 5 g, about 6 g, or about 7 g fiber per 8 oz.
serving. In other cases, about 4 g to about 8 g of fiber (e.g.,
about 5 g, about 6 g, or about 7 g) per 12 oz. serving can be targeted.
In some embodiments, about 1.7% fiber by weight of a fluid ingestible
composition is targeted.
[0058] In some cases, a fluid ingestible composition includes only
alginate as a soluble anionic fiber. In other cases, alginate and
pectin are used. A ratio of alginate to pectin (e.g., total alginate
to total pectin) in a fluid ingestible composition can range from
about 8:1 to about 1:8, and any ratio therebetween (e.g., alginate:pectin
can be in a ratio of about 1:1, about 1.2:1, about 1.3:1, about
1.4:1, about 1.5:1, about 1.6:1, about 1.62:1, about 1.7:1, about
1.8:1, about 1.9:1, about 2:1, about 3:1, about 4:1, about 5:1,
about 5.3:1, about 5.6:1, about 5.7:1, about 5.8:1, about 5.9:1,
about 6:1, about 6.1:1, about 6.5:1, about 7:1, about 7.5:1, about
7.8:1, about 2:3, about 1:4, or about 0.88:1). In cases where alginate
and pectin are in a ratio of about 0.5:1 to about 2:1, it is believed
that pectin and alginate electrostatically associate with one another
to gel in the absence of multivalent cations; thus, while not being
bound by theory, it may be useful to delay the introduction of multivalent
cations until after such gel formation. In other cases, where the
ratio of alginate to pectin is in the range from about 3:1 to about
8:1, it may be useful to include a multivalent cation source, such
as, a calcium source (e.g., to crosslink the excess alginate) to
aid gel formation in the stomach. In these cases, the inventors
believe, while not being bound by any theory, that the lower amount
of pectin protects the alginate from precipitating as alginate at
the low pHs of the stomach environment, while the multivalent cation
source cross-links and stabilizes the gels formed.
[0059] A fluid ingestible composition can have a pH from about
3.9 to about 4.5, e.g., about 4.0 to about 4.3 or about 4.1 to about
4.2. At these pHs, it is believed that the fluid ingestible compositions
are above the pKas of the alginate and pectin acidic subunits, minimizing
precipitation, separation, and viscosity of the solutions. In some
cases, malic, phosphoric, and citric acids can be used to acidify
the compositions. In some cases, a fluid ingestible composition
can have a pH of from about 5 to about 7.5. Such fluid ingestible
compositions can use pH buffers known to those having ordinary skill
in the art.
[0060] Sweeteners for use in a fluid ingestible composition can
vary according to the use of the composition. For beverages, low
glycemic sweeteners may be preferred, including trehalose, isomaltulose,
aspartame, saccharine, and sucralose. Sucralose can be used alone
in certain formulations. The choice of sweetener will impact the
overall caloric content of a fluid ingestible composition. In certain
cases, fluid ingestible compositions can be targeted to have 40
calories/12 oz serving.
[0061] A fluid ingestible composition can demonstrate gel strengths
of about 20 to about 250 grams force (e.g., about 60 to about 240,
about 150 to about 240, about 20 to 30, about 20 to about 55, about
50 to 200; about 100 to 200; and about 175 to 240), as measured
in a static gel strength assay. Gel strengths can be measured in
the presence and absence of a multivalent cation source, such as,
a calcium source.
[0062] A fluid ingestible composition can exhibit a viscosity in
the range of from about 15 to about 100 cPs, or any value therebetween,
at a shear rate of about 10.sup.-5, e.g., about 17 to about 24;
about 20 to about 25; about 50 to 100, about 25 to 75, about 20
to 80, or about 15 to about 20 cPs. Viscosity can be measured by
those skilled in the art, e.g., by measuring flow curves of solutions
with increasing shear rate using a double gap concentric cylinder
fixture (e.g., with a Parr Physica Rheometer).
[0063] A fluid ingestible composition can include a multivalent
cation sequestrant, e.g., to prevent premature gellation of the
soluble anionic fibers. A multivalent cation sequestrant can be
selected from EDTA and its salts, EGTA and its salts, sodium citrate,
sodium hexametaphosphate, sodium acid pyrophosphate, trisodium phosphate
anhydrous, tetrasodium pyrophosphate, sodium tripolyphosphate, disodium
phosphate, sodium carbonate, and potassium citrate. A multivalent
cation sequestrant can be from about 0.001% to about 0.3% by weight
of the ingestible composition. Thus, for example, EDTA can be used
at about 0.0015% to about 0.002% by weight of the ingestible composition
and sodium citrate at about 0.230% to about 0.260% (e.g., 0.250%)
by weight of the ingestible composition.
[0064] A fluid ingestible composition can include a juice or juice
concentrate and optional flavorants and/or colorants. Juices for
use include fruit juices such as apple, grape, raspberry, blueberry,
cherry, pear, orange, melon, plum, lemon, lime, kiwi, passionfruit,
blackberry, peach, mango, guava, pineapple, grapefruit, and others
known to those skilled in the art. Vegetable juices for use include
tomato, spinach, wheatgrass, cucumber, carrot, peppers, beet, and
others known to those skilled in the art.
[0065] The brix of the juice or juice concentrate can be in the
range of from about 15 to about 85 degrees, such as about 25 to
about 50 degrees, about 40 to about 50 degrees, about 15 to about
30 degrees, about 65 to about 75 degrees, or about 70 degrees. A
fluid ingestible composition can have a final brix of about 2 to
about 25 degrees, e.g., about 5, about 10, about 12, about 15, about
20, about 2.5, about 3, about 3.5, about 3.8, about 4, or about
4.5.
[0066] Flavorants can be included depending on the desired final
flavor, and include flavors such as kiwi, passionfruit, pineapple,
coconut, lime, creamy shake, peach, pink grapefruit, peach grapefruit,
pina colada, grape, banana, chocolate, vanilla, cinnamon, apple,
orange, lemon, cherry, berry, blueberry, blackberry, apple, strawberry,
raspberry, melon(s), coffee, and others, available from David Michael,
Givaudan, Duckworth, and other sources.
[0067] Colorants can also be included depending on the final color
to be achieved, in amounts quantum satis that can be determined
by one having ordinary skill in the art.
[0068] Rapid gelling occurs when soluble anionic fibers, such as
alginate or pectin, are mixed with soluble calcium sources, particularly
the calcium salts of organic acids such as lactic or citric acid.
For beverage products, this reactivity prevents the administration
of soluble anionic fiber and a highly soluble calcium source in
the same beverage. In the present invention, this problem is overcome
by administering the soluble anionic fiber and the soluble calcium
source in different product components.
Solids
[0069] At least one soluble anionic fiber can be present in a solid
ingestible composition in any form or in any mixtures of forms.
A form can be a formed, unformed, or both. Formed forms include
extruded forms, spray-dried forms, roll-dried forms, or dry-blended
forms. For example, a snack bar can include at least soluble anionic
fiber present as a formed food product (e.g., a crispy), at least
one soluble anionic fiber in an unextruded form (e.g., as part of
the bar), or both.
[0070] A formed food product can be cold- or hot-extruded and can
assume any type of extruded form, including without limitation,
a bar, cookie, bagel, crispy, puff, curl, crunch, ball, flake, square,
nugget, and snack chip. In some cases, a formed food product is
in bar form, such as a snack bar or granola bar. In some cases,
a formed food product is in cookie form. In other cases, a formed
food product is in a form such as a crispy, puff, flake, curl, ball,
crunch, nugget, chip, square, chip, or nugget. Such formed food
products can be eaten as is, e.g., cookies, bars, chips, and crispies
(as a breakfast cereal) or can be incorporated into a solid ingestible
composition, e.g., crispies incorporated into snack bars.
[0071] A solid form may also be a lollipop or a lolly that is made
of hardened, flavored sugar mounted on a stick and intended for
sucking or licking. One form of lollipop has a soft-chewy filling
in the center of the hardened sugar. The soft filling may be a gum,
fudge, toffee, caramel, jam, jelly or any other soft-chewy filling
known in the art. The at least one multivalent cation may be in
the soft-chewy center or the harnend sugar. Likewise, at least fiber
may be in the soft-chewy center or the harnend sugar. A hard candy
filled with a soft-chewy center is another embodiment of the present
invention. This embodiment is similar to the lollipop, except it
is not mounted on a stick. The soft-chewy filling may be in the
center or swirled or layered with the hard sugar confection.
[0072] A cookie or mini-bar can include at least one soluble anionic
fiber in an unprocessed form or in a processed (e.g., formed) form.
A snack chip can include at least one soluble anionic fiber in formed
form or in spray-dried form, or both, e.g., a formed soluble anionic
fiber-containing chip having at least one soluble anionic fiber
spray-dried on the chip.
[0073] A solid ingestible composition can include optional additions
such as frostings, icings, coatings, toppings, drizzles, chips,
chunks, swirls, or layers. Such optional additions can include at
least one multivalent cation, at least one soluble anionic fiber,
or both.
[0074] Solid ingestible compositions can provide any amount from
about 0.5 g to about 10 g total soluble anionic fiber per serving,
e.g., about 0.5 g to about 5 g, about 1 g to about 6 g, about 3
g to about 7 g, about 5 g to about 9 g, or about 4 g to about 6
g. For example, in some cases, about 1 g, about 2 g, about 3 g,
about 4 g, about 5 g, about 6 g, about 7 g, about 8 g, or about
9 g of soluble anionic fiber per serving can be provided.
[0075] A solid ingestible composition can include at least one
soluble anionic fiber at a total weight percent of the ingestible
composition of from about 4% to about 50% or any value therebetween.
For example, a solid ingestible composition can include at least
one soluble anionic fiber of from about 4% to about 10% by weight;
or about 5% to about 15% by weight; or about 10% to about 20% by
weight; or about 20% to about 30% by weight; or about 30% to about
40% by weight; or about 40% to about 50% by weight.
[0076] A formed food product can be from about 0% to 100% by weight
of an ingestible composition, or any value therebetween (about 1%
to about 5%; about 5% to about 10%; about 10% to about 20%; about
20% to about 40%; about 30% to about 42%; about 35% to about 41%;
about 37% to about 42%; about 42% to about 46%; about 30% to about
35%; about 40% to about 50%; about 50% to about 60%; about 60% to
about 70%; about 70% to about 80%; about 80% to about 90%; about
90% to about 95%; about 98%; or about 99%). For example, a formed
bar, cookie, or chip can be about 80% to about 100% by weight of
an ingestible composition or any value therebetween.
[0077] Alternatively, an ingestible composition can include about
30% to about 55% by weight of a formed food product or any value
therebetween, e.g., about 32%, about 33%, about 34%, about 35%,
about 36%, about 37%, 3 about 8%, about 39%, about 40%, about 42%,
about 45%, about 48%, about 50%, about 52%, or about 54% by weight
of a formed food product. For example, a snack bar composition can
include formed crispies in an amount of from about 32% to about
46% by weight of the snack bar.
Crispies
[0078] A formed food product, e.g., for inclusion in an ingestible
composition, can be a crispy. For example, crispies that include
one or more alginates and/or pectins in a total amount of about
30% to about 35% by weight can be included in a snack bar in an
amount of about 32% to about 45% by weight of the snack bar. Crispies
can be prepared using a fiber blend as described herein. Crispies
can also include, among other things, about 52% to about 58% by
weight of one or more of a rice flour, corn meal, and/or corn cone;
and about 2% to about 10% of a protein isolate. Crispies can be
prepared using methods known to those having ordinary skill in the
art, including cold and hot extrusion techniques.
[0079] An ingestible composition or formed food product can include
one or more of the following: cocoa, including flavonols, and oils
derived from animal or vegetable sources, e.g., soybean oil, canola
oil, corn oil, safflower oil, sunflower oil, etc. For example, a
formed food product can include cocoa or oils in an amount of about
3% to about 10% (e.g., about 3% to about 6%, about 4% to about 6%,
about 5%, about 6%, about 7%, or about 4% to about 8%) by weight
of the formed food product.
[0080] One embodiment of the present invention is a stable two-phase
product having at least one soluble anionic fiber and at least one
multivalent cation in the same product, but formulated so that the
soluble anionic fiber and multivalent cation do not react during
processing or prior to ingestion, but react following ingestion
as a standard multivalent cation-anion fiber reaction. One product
design includes a jam phase center and a crisp baked solid phase
outside the fluid jam phase. One embodiment places the soluble anionic
fiber in the jam phase and places the multivalent cation in the
baked dough phase. However, it has been found that the stability
of this embodiment is less than optimal from an organoleptic standpoint.
That is, it provided a solid, rubberlike jam phase instead of pleasant
texture due to the migration of the multivalent cation from the
baked dough phase.
[0081] Adding the soluble anionic fiber to the baked dough phase
and the multivalent cation to the jam phase, which provides a cookie
that reduces the water activity of the fiber-containing phase that
restricted fiber so that it was prevented from reacting with the
multivalent cation. The placement of the multivalent cation into
a postbake, medium water activity filler, e.g., the jam phase, allowed
the cation to be formulated in the product with an acceptable organoleptic
profile and an inability to react with fiber even if minor migration
occurs.
[0082] The water activities of both components can be further adjusted
to deliver a product with not only restrictive reaction in place
but acceptable eating qualities and the right characteristics needed
to for ease of manufacturing.
[0083] Types of salts tested include calcium fumarate, tricalcium
phosphate, dicalcium phosphate dihydrate and calcium carbonate.
The gram weight tested will vary depending on the salt type due
to its characteristic calcium load. The piece weight of the product
under discussion has been about 13 to about 20 g, with each piece
delivering 50 to about 75 kcal.
[0084] BENEFAT.RTM. is a family of triglyceride blends made from
the short and long chain fatty acids commonly present in the diet.
It is the uniqueness of these fatty acids that contribute to the
range's reduced calorie claim. BENEFAT.RTM. products are designed
to replace conventional fats and oils in dairy, confectionery and
bakery products, giving full functionality with significantly reduced
energy and fat content. BENEFAT.RTM. is the Danisco trade name for
SALATRIM, the abbreviation for short and long-chain triglyceride
molecules. The short-chain acids (C.sub.2-C.sub.4) may be acetic,
propionic, butyric or a combination of all three, while the long-chain
fatty acid (C.sub.16-C.sub.22) is predominantly stearic and derived
from fully hardened vegetable oil. Unlike other saturated fatty
acids, stearic acid has a neutral effect on blood cholesterol. BENEFAT.RTM.
is also free of trans fatty acids and highly resistant to oxidation.
Compared to the 9 calories per gram of traditional fat, BENEFAT.RTM.
contains just 5 calories per gram (US regulation) or 6 calories
per gram (EU regulation), at the same time giving foods a similar
creamy taste, texture, and mouthfeel as full-fat products. Metabolisation
upon consumption occurs in much the same way as with other food
components.
[0085] A preferred product features include about 500 to about
1500 mg of alginate are present, the multivalent cation is calcium
wherein about 50 to about 500 mg of elemental calcium are delivered.
The product has low calories between about 50 to about 100 calories
and is a cookie with a jam filling.
[0086] The soluble anionic fiber can be provided in one beverage
component, and a soluble calcium source can be provided in a second
beverage component. The first component and the second component
are provided separately to the user in a bottle or cup, and the
user consumes the two components concurrently or sequentially.
[0087] The soluble anionic fiber may be delivered in a beverage
component and a soluble calcium source may be provided separately
in a solid edible component. The fluid fiber component and the solid
calcium-containing component are consumed concurrently or sequentially.
[0088] The soluble anionic fiber component may be provided in a
solid edible component and the soluble calcium source may be provided
separately in a fluid component. The fluid calcium-containing component
and the solid fiber-containing component are consumed concurrently
or sequentially.
[0089] The soluble anionic fiber component and the soluble calcium
source are both provided in solid edible components. The components
may be provided in the form of separate items for consumption, or
both components may be combined in a single solid form for consumption.
This single solid form may contain the soluble anionic fiber in
one phase, such as a layer or filling, and the calcium source may
be provided in a separate phase, such as a layer or filling. Alternatively,
the fiber and calcium source may be intimately mixed in the same
solid form.
[0090] The ingestible composition useful in the present invention
can be provided in any package, such as enclosed in a wrapper or
included in a container. An ingestible composition can be included
in an article of manufacture. An article of manufacture that includes
an ingestible composition described herein can include auxiliary
items such as straws, napkins, labels, packaging, utensils, etc.
[0091] An article of manufacture can include a source of at least
one multivalent cation. For example, a source of at least one multivalent
cation can be provided as a fluid, e.g., as a beverage to be consumed
before, during, or after ingestion of the ingestible composition.
In other cases, at least one multivalent cation can be provided
in a solid or gel form. For example, a source of at least one multivalent
cation can be provided in, e.g., a jelly, jam, dip, swirl, filling,
or pudding, to be eaten before, during, or after ingestion of the
ingestible composition. Thus, in some embodiments, an article of
manufacture that includes a cookie or bar solid ingestible composition
can also include a dip comprising a source of at least one multivalent
cation, e.g., into which to dip the cookie or bar solid ingestible
composition.
[0092] Also provided are articles of manufacture that include a
fluid ingestible composition. For example, a fluid ingestible composition
can be provided in a container. Supplementary items such as straws,
packaging, labels, etc. can also be included. Alternatively, the
soluble anionic fiber may be included in a beverage and the multivalent
cation may be provided inside, outside or both of a straw or stirring
stick. In some cases, at least one multivalent cation, as described
below, can be included in an article of manufacture. For example,
an article of manufacture can include a fluid ingestible composition
in one container and a source of multivalent cations in another
container. Two or more containers may be attached to one another.
Methods of Reducing Caloric Consumption
[0093] A soluble anionic fiber (such as alginate and pectin) is
administered concurrently with a multivalent cation source such
as a water-soluble calcium salt to reduce food intake. Continued
use of these compositions by individuals in need of weight loss
will result in a cumulative decrease in caloric consumption, which
will result in weight loss or diminished weight gain. Although not
wishing to be bound by theory, the inventors hypothesize that the
multivalent cation calcium ions of the soluble calcium source cross
link the carboxylate groups on the fiber molecules, resulting in
the formation of highly viscous or gelled materials. This gelling
effect increases the viscosity of the gastric and intestinal contents,
slowing gastric emptying, and also slowing the rate of macro-nutrient,
e.g., glucose, amino acids, fatty acids, and the like. These physiological
effects prolong the period of nutrient absorption after a meal,
and therefore prolong the period during which the individual experiences
an absence of hunger. The increased viscosity of the gastrointestinal
contents, as a result of the slowed nutrient absorption, also causes
a distal shift in the location of nutrient absorption. This distal
shift in absorption may trigger the so-called "ileal brake"
and the distal shift may also cause in increase in the production
of satiety hormones such as GLP-1 and PYY.
[0094] Provided herein are methods employing the ingestible compositions
described herein. For example, a method of facilitating satiety
and/or satiation in an animal is provided. The method can include
administering an ingestible composition to an animal. An animal
can be any animal, including a human, monkey, mouse, rat, snake,
cat, dog, pig, cow, sheep, horse, or bird. Administration can include
providing the ingestible combination either alone or in combination
with other meal items. Administration can include co-administering,
either before, after, or during administration of the ingestible
composition, a source of at least one multivalent cation, such as,
calcium, or a sequestered source of calcium, as described herein.
At least one multivalent cation can be administered within about
a four-hour time window flanking the administration of the ingestible
composition. For example, a source of calcium, such as a solution
of calcium lactate, can be administered to an animal immediately
after the animal has ingested a fluid ingestible composition as
provided herein. Satiety and/or satiation can be evaluated using
consumer surveys (e.g., for humans) that can demonstrate a statistically
significant measure of increased satiation and/or satiety. Alternatively,
data from paired animal sets showing a statistically significant
reduction in total caloric intake or food intake in the animals
administered the ingestible compositions can be used as a measure
of facilitating satiety and/or satiation.
[0095] As indicated previously, the ingestible compositions provide
herein can hydrate and gel in the stomach and/or small intestine,
leading to increased viscosity in the stomach and/or small intestine
after ingestion. Accordingly, provided herein are methods for increasing
the viscosity of stomach and/or small intestine contents, which
include administering an ingestible composition to an animal. An
animal can be any animal, as described above, and administration
can be as described previously. Viscosity of stomach contents can
be measured by any method known to those having ordinary skill in
the art, including endoscopic techniques, imaging techniques (e.g.,
MRI), or in vivo or ex vivo viscosity measurements in e.g., control
and treated animals.
[0096] The inventors have found that a product containing an anionic
fiber (alginate) in combination with a multivalent cation (calcium)
is effective, in comparison to a similar composition lacking alginate,
in promoting weight loss in individuals on a low intensity weight
loss program. The low intensity weight loss program involved a focus
on monitoring food consumption and promoting exercise, but did not
involve the extensive or uncomfortable dieting regimens of many
weight loss programs (such programs are frequently unsuccessful
in achieving weight loss because individuals fail to comply because
of the hunger and discomfort arising from the dieting regimen).
The inventors have found that compositions containing effective
amounts of a combination of soluble anionic fiber and multivalent
cation, when consumed in the context of a low intensity weight loss
program, resulted in a caloric deficit of about 150 kcal to about
300 kcal per day.
[0097] Without being bound by theory, the inventors believe that
consumption of compositions containing weight loss effective amounts
of a combination of a soluble anionic fiber and a multivalent cation,
in the context of a low intensity weight loss program, is an especially
effective means of promoting weight loss in an individual desiring
weight loss. The effects of the combination of anionic fiber and
multivalent cation in increasing the viscosity of the gastrointestinal
contents and slowing nutrient absorption prolong satiety and reduce
appetite in individuals consuming these compositions, thereby aiding
their effort to comply with this low intensity weight loss program.
The consumption of these compositions is especially effective in
achieving caloric deficits of about 150 to about 300 kcal per day,
when consumed in the context of a low intensity weight loss program.
[0098] Additionally, with being bound by theory, the inventors
believe that caloric deficits of greater than about 350 kcal to
about 1000 kcal per day, particularly greater than about 500 kcal
per day, will cause food cravings and hunger sensations of such
magnitude in many individuals so as to overwhelm the food intake
reducing properties of the inventive compositions.
Weight Loss/Weight Maintenance Programs
[0099] Any weight loss/weight maintenance program can be used in
the present invention. It is preferred that the weight loss/weight
maintenance program include an exercise component. Weight loss programs
include meal planning, meal replacement, portion control, exercise,
caloric dilution, cognitive modification, group or individual counseling,
coaching, or support, or combinations thereof. Examples of currently
popular weight loss/weight management programs include the SOUTH
BEACH DIET.RTM., the ATKINS DIET.RTM., NUTRITSYSTEM.RTM., JENNY
CRAIG.RTM., MEDIFAST.RTM., WEIGHT WATCHERS.RTM., BODY FOR LIFE.RTM.,
Step Diet, and the like.
[0100] The SOUTH BEACH DIET.RTM. includes the following phases:
[0101] Phase 1: The South Beach Diet begins with a restricted two-week
induction phase where most carbohydrates (such as, rice, pasta,
and breads) must be avoided. There are three meals a day and snacks
which are eaten until hunger is satisfied. Meats, shellfish, chicken,
turkey, and fish can be eaten-along with nuts, cheese (fat-free),
eggs, salads, and vegetables.
[0102] Phase 2: The second phase includes specific meal plans and
recipes. It sparingly reintroduces some of the foods avoided in
Phase 1. This length of time on this phase is dependent on the individual's
goals.
[0103] Phase 3: The third phase is about living the lifestyle more
than a phase. This phase is about eating healthy and weight maintenance
[0104] NUTRISYSTEM.RTM. is a portion-controlled weight loss program
that provides on-line analysis to calculate an individual's calorie
requirements. From this, meal plans can be calculated and the company
will ship all meals to an individual.
[0105] The ATKINS DIET.RTM. is diet that severely restricts carbohydrate
intake. Carbohydrates sources such as foods with sugar, bread, cereal,
some starchy vegetables and pasta are avoided. Weight loss on the
ATKINS DIET.RTM. is based on the premise that the main source of
energy for humans is carbohydrates. When a human is carbohydrate
challenged, the body must use another source of energy. The next
energy source for the body is stored body fat. Once the body is
using fat as an energy source, the body is said to be in ketosis.
Another premise is that carbohydrates stimulate the creation of
insulin. Insulin converts excess carbohydrates to fat. Thus, the
less carbohydrates available, the less insulin produced and the
less fat created.
[0106] MEDIFAST.RTM. is a fast weight loss plan using meal replacements
and regular food. The program has been prescribed by doctors for
many years (particularly for obese people). This 5 and 1 plan is
made up of 5 meal replacements per day, including shakes, bars,
soups, oatmeal, and puddings. One meal per day is a "lean and
green" meal--a small portion of lean meat and up to 2 cups
of salad or vegetables. Individuals eat every 2-3 hours and must
drink a minimum of 64 oz of fluid (water) per day. Other beverages
can be consumed in addition to this.
[0107] WEIGHT WATCHERS.RTM. is a portion control and exercise plan.
The core plan includes eating portions from a list of healthy foods
from all the food group, having an occasional treat, and exercise.
[0108] The JENNY CRAIG.RTM. weight management program is a portion-controlled
diet plan based around the traditional United States dietary guidelines
(e.g., USDA food pyramid). It is a calorie controlled program where
all meals are shipped to the individual. The program involves visiting
a JENNY CRAIG.RTM. center for weigh-ins, and consulting one-on-one
with one of their weight loss consultants. A fitness and exercise
component is also part of the program.
[0109] The BODY FOR LIFE.RTM. diet includes 6 meals per day. Portion
size is emphasized rather than calorie counts. A typical meal might
include one portion of protein, and one portion of carbohydrate.
Cheating is allowed one day each week. The exercise component includes
20 minutes 3 times per week of aerobic exercise, and lifting weights
for 3 times a week (45 minutes per session).
[0110] The Step Diet has six components: 1) prepare for weight
management, 2) stop gaining weight, 3) Set realistic goals, 4) make
small changes to an individual's daily routine, e.g., take the stairs
instead of an elevator, 5) find energy balance point that increases
exercise to make up for the drop in metabolism, and 6) plan for
lifelong success. For example, get as much walking and physical
activity in as an individual can and have the individual go back
and adjust how much they eat. The more an individual can walk, the
more the individual can eat."
[0111] Also provided are methods for promoting weight loss by administering
an ingestible composition as provided herein to an animal. Administration
can be as described previously. The amount and duration of such
administration will depend on the individual's weight loss needs
and health status, and can be evaluated by those having ordinary
skill in the art. The animal's weight loss can be measured over
time to determine if weight loss is occurring. Weight loss can be
compared to a control animal not administered the ingestible composition.
[0112] The following examples are representative of the invention,
and are not intended to be limiting to the scope of the invention.
EXAMPLES
Example 1
[0113] A cookie having a solid phase, e.g., a baked dough phase,
containing a soluble anionic fiber blend and a fluid phase, e.g.,
jam phase containing a soluble calcium source deposited in the baked
dough phase was produced.
[0114] The baked dough phase was prepared by adding BENEFAT.RTM.
and lecithin to a premix of flour, cellulose, egg white, salt, leavening
and flavors in a Hobart mixer and creaming by mixing at low speed
for about 1 minute followed by high speed for about 2 minutes. The
liquids were added to creamed mixture and blended at medium speed
for about 2 minutes.
[0115] The fiber blend used contained about 46% sodium alginate
LBA (ISP, San Diego, Calif.), about 39.6% sodium alginate GHB (ISP),
and about 14.4% pectin (USP-L200, Kelco, San Diego, Calif.).
[0116] The fiber blend and glycerin were added to a separate bowl
and combined. This combined fiber/glycerin material was added to
the other ingredients in the Hobart mixer and was mixed on medium
speed for about 1 minute. The resulting dough was then sheeted to
desired thickness on a Rhondo sheeter and a dough pad measuring
about 3 inched by about 6 inches was created.
[0117] The jam phase was prepared by adding a premixed BENEFAT.RTM./calcium
source mixture to the jam base and mixed until uniformly mixed.
A predetermined amount of the jam was then added onto the top surface
of the cookie dough pad. The dough pad edges were wetted and sealed.
Bars were baked at 325.degree. F. for about 9 minutes, cut, cooled
and the resulting cookies were individually packaged. The total
caloric value of each cookie was about 50 kcal.
[0118] Dough Phase TABLE-US-00001 % Dough % Total Ingredient Phase
Formulation flour - all purpose 29.140 12.165 cellulose, solka floc
- International 6.980 2.914 Fiber Corp. Powder egg white 0.580 0.242
salt (NaCl) 0.200 0.083 sodium Bicarbonate Grade #1 0.510 0.213
cookie Dough Flavor 0.170 0.071 BENEFAT 2.060 0.860 Lecithin 0.640
0.267 polydextrose litesse 70% syrup, Ultra 15.870 6.625 Water 11.830
4.939 Liquid vanilla flavor 0.280 0.117 sucralose, 25% liquid. 0.090
0.038 potassium sorbate 0.250 0.104 alginate fiber blend 17.400
7.264 glycerine, optima 99.7% USP 14.000 5.845 100.000 41.70
[0119] Jam Phase: TABLE-US-00002 % Jam % Total Ingredient Phase
Formulation BENEFAT 21.100 12.291 calcium fumarate trihydrate 11.000
6.408 reduced calorie strawberry filling (SMUCKERS) 67.900 39.553
100.000 58.25
Control
[0120] Dough Phase: TABLE-US-00003 % Dough % Total Ingredient Phase
Formulation Flour - all purpose 29.140 12.530 cellulose, solka floc
- International 6.980 3.001 Fiber Corp. powder egg white 0.580 0.249
salt (NaCl) 0.200 0.086 sodium bicarbonate Grade #1 0.510 0.219
cookie dough flavor 0.170 0.073 BENEFAT 19.450 8.364 Lecithin 0.640
0.275 polydextrose litesse 70% syrup, Ultra 15.870 6.824 Water 11.830
5.087 Liquid vanilla flavor 0.280 0.120 sucralose, 25% liquid. 0.090
0.039 potassium sorbate 0.250 0.108 alginate fiber blend 0.000 0.000
glycerine, Optim 99.7% USP 14.000 6.020 100.000 43.00
[0121] Jam Phase: TABLE-US-00004 % Jam % Total Ingredient Phase
Formulations BENEFAT 32.100 19.260 reduced calorie strawberry filling
(SMUCKERS) 67.900 40.740 Total 100.000 60.00
Measurement of Intestinal Viscosity
[0122] Fully grown female Yucatan minipigs (Charles River Laboratories,
Wilmington, Mass.), weighing about 90 kg, were fitted with indwelling
silicone rubber sample ports (Omni Technologies, Inc., Greendale,
Ind.) implanted in a surgically created dermal fistula at the ileocecal
junction. The sample ports were sealed by a removable cap. These
ports permit removal of samples of digesta as it passes from the
ileum to the cecum. Additional details of this procedure were presented
in B. Greenwood van-Meerveld et al., Comparison of Effects on Colonic
Motility and Stool Characteristics Associated with Feeding Olestra
and Wheat Bran to Ambulatory Mini-Pigs, Digestive Diseases and Sciences
44:1282-7 (1999), which is incorporated herein by reference.
[0123] Three Yucatan minipigs with the fistulas described above
were housed in individual stainless steel pens in a windowless room
maintained on a cycle of 12 hours of light and 12 hours of dark.
They were conditioned to consume low fiber chow (Laboratory Mini-Pig
Diet 5L80, PMI Nutritional International, Brentwood, Mo.). This
chow contains about 5.3% fiber. The pigs were fed once each day,
in the morning. Water was provided ad libitum throughout the day.
[0124] Samples were taken from the ileal sample port immediately
after feeding, and then at about 30 minute intervals for about 300
minutes. The volume of sample collected was about 50 to 130 ml.
All samples were assayed for viscosity within 30 minutes after collection.
[0125] Samples of digesta were collected in sealed plastic containers.
Viscosity of the digesta was measured with a Stevens QTS Texture
Analyzer (Brookfield Engineering, Inc., Middleboro, Mass.). This
instrument measures the relative viscosity of digesta by a back
extrusion technique. The instrument was comprised of a stage plate,
a 60 cm vertical tower, a mobile beam and a beam head that contains
a load-cell. During back extrusion, the beam descends at a constant
rate, and the force required to back extrude the sample was recorded
over time. The sample containers were 5 cm deep spherical aluminum
cups with an internal diameter of about 2.0 cm. The volume of the
cup was about 20 ml. The spherical probe consists of a 1.9 cm Teflon
ball mounted on a 2 mm threaded rod which was attached to the mobile
beam. The diameters of the sample cup and probe allow for a wide
range of viscosity (liquid to solid digesta) to be measured without
approaching the maximum capacity of the rheometer (25 kg/peak force).
During each test, the beam thrusts the probe into the test sample
at a constant rate (12 cm/second) for a 2 cm stroke, forcing the
sample to back-extrude around the equatorial region of the probe.
The peak force for back extrusion at a controlled stroke rate was
proportional to the viscosity of the sample. At each time point,
2-6 samples from each pig were tested, and the mean peak force was
calculated and recorded.
[0126] The test for effects of fiber containing cookies on viscosity
was performed by providing each pig with its daily ration of low
fiber chow (1400 g). Before feeding, one cookie was gently broken
into four to six pieces and mixed into the chow. The animals have
unlimited access to water during and after feeding. The effect of
the cookie of this example containing fiber and calcium on intestinal
viscosity was shown in FIG. 1. Each treatment was provided to each
of three pigs on three separate days to yield nine replicates for
each sample. Each point plotted in FIG. 1 is the mean of these nine
determinations. The fiber and calcium containing cookie produced
viscosities significantly greater than those produced by control
chow (p<0.05, as measured by a two-tailed t-test) at the time
points from 210 minutes through 300 minutes.
Example 2
[0127] A study to evaluate the effects of soluble fiber and calcium
on food intake was performed by the following procedure.
[0128] The study was a within-subjects design with 30 participants
completing three one week treatment periods, with a washout period
of one week between treatment periods. Treatment order was counterbalanced
to have five subjects randomly assigned to each of six possible
treatment sequences. Subjects in each treatment period consumed
a test beverage at breakfast and after lunch (mid-afternoon). In
one treatment period, subjects consumed a placebo beverage without
fiber. In two treatment periods, the test beverage contained a blend
of soluble fibers of one of the following compositions: TABLE-US-00005
2.8 g Fiber 1.0 g Fiber Placebo Ingredient % % % Water 95.470 96.400
97.010 Trisodium citrate dihydrate 0.250 0.250 0.250 LBA alginate
(ISP) 0.640 0.210 0.000 GHB alginate (ISP) 0.550 0.180 0.000 USP
L200 pectin (Kelco) 0.200 0.066 0.000 Apple juice concentrate 2.300
2.300 2.300 EDTA 0.002 0.002 0.002 Sucralose 0.011 0.011 0.011 Malic
acid, granular 0.200 0.200 0.200 Red 40, 10% solution 0.001 0.001
0.001 Flavor 0.380 0.380 0.380 Total 100.000 100.0001 100.000
[0129] The fiber drinks were consumed with a separate beverage
containing calcium lactate (not more than 500 mg elemental calcium
per serving). The placebo was taken with a second placebo beverage
matched for flavor and calories, but without calcium lactate. The
test drink containing calcium lactate or corresponding placebo had
the following composition: TABLE-US-00006 Calcium Placebo Calcium
Free Placebo Ingredient % % Water 96.430 99.846 Calcium lactate
3.065 0.000 Malic acid 0.330 0.330 Sucralose 0.050 0.020 Yellow
#5, 1% solution 0.007 0.007 Red #40, 1% Solution 0.0069 0.0069 Flavor
0.110 0.110 Total 100.000 100.000
[0130] Subjects in the study were premenopausal women selected
without regard to racial or ethnic background. Eligible women had
to be between 20 and 40 years of age, non-smokers, and overweight
or obese (body mass index, or BMI, of 25-35 kg per square meter).
Test Sessions and Experimental Measurements
[0131] Test sessions occurred on the first and seventh day of the
use of each experimental period. The night before the sessions,
subjects consumed an evening meal of their own choosing that was
replicated the night before each test session. Test sessions began
between 7:00 and 9:00 AM. Subjects first completed a short questionnaire
to ensure they had consumed the evening meal, and had not been ill
in the previous week. Immediately before a standardized breakfast
meal (choice of bagel or raisin bran cereal) they were asked to
consume a fiber test beverage within a three minute interval, which
consists of the first part of the test beverage (fiber or placebo)
first, immediately followed by the second part of the test beverage
calcium or placebo). They were then served the standard breakfast.
They returned to the lab for lunch 4-5 hours later, and dinner 9-10
hours later. They were provided with a portable cooler containing
the test beverage (fiber or placebo beverage, and the calcium beverage
or calcium-free placebo beverage), and a bottle of water. They were
instructed to consume the test beverage 21/2 hours after the completion
of lunch and not to consume any food during the day except the test
meals provided, the test beverages, and the bottled water.
[0132] At the test sessions, lunch and dinner were provided as
buffet-style meals. Subjects were also provided snacks for consumption
during the evening. They were told to consume as much of the snacks
as they desired. Lunch and dinner servings of each individual food
were weighed to the nearest 0.1 g before and after consumption to
determine caloric and macronutrient intake. Evening snacks were
returned to the test site to determine food consumption.
[0133] Subjects were asked to consume 14 test drinks during each
week of the three week long experimental periods. On Day 1, as mentioned
above, they drank one two-part test beverage before breakfast, and
one 2.5 hours after lunch. Additionally, on the first test day they
were provided with five refrigerated test beverages (5 first part
and 5 second part) to take home. They were instructed to consume
one test beverage, which was one first part followed by one second
part, before breakfast, and another test beverage about 31/2 hours
after lunch each day on the second through sixth days. Subjects
returned to the laboratory on the seventh day to repeat the procedure
of the first day.
Data Analysis
[0134] Data were analyzed using the Statistical Analysis System
(SAS Version 8.2, Cary, N.C.). The mixed model procedure was used
to test for treatment differences, with treatment condition (low
fiber, high fiber, and placebo), day (1 or 7) and the interaction
of condition and day entered into the statistical models. The effects
of treatment session was also tested as a covariate and kept in
the final model when found to be significant. The endpoint measurements
included the total daily energy and macronutrient content of foods
consumed, as well as at each individual meal (breakfast, lunch,
dinner, and evening snack).
[0135] Consumption of the two different fiber containing beverages
(1 g and 2.8 g per serving) resulted in a trend toward reduction
in total calorie intake measured over the 24 hour period beginning
with the morning beverage. TABLE-US-00007 Effect of Fiber Beverages
on Total Calorie Mean Kcal Standard P value vs. Condition Intake
Error placebo Placebo 2634 109 0.17 1 g fiber beverage 2512 110
0.17 2.8 g fiber beverage 2510 109
[0136] Consumption of both the fiber containing beverages (1 g
and 2.8 g per serving) resulted in a significant decrease in food
consumption at dinner, as shown below. TABLE-US-00008 Effect of
Fiber Beverages on Caloric Intake at Dinner Mean Kcal Standard P
value vs. Condition Intake Error placebo Placebo 765 37 1 g fiber
beverage 689 37 0.039 2.8 g fiber beverage 678 37 0.016
[0137] The 1 g fiber beverage reduced dinner food intake by an
average of 76 kcal, and the 2.8 g beverage provided a reduction
of 87 kcal. The P values, determined by a post-hoc Tukey's analysis,
indicated that these results were statistically significant (p<0.05).
[0138] Further analysis of the nutrient composition of the individual
foods consumed indicated that the consumption of the fiber beverages
was associated with a significant reduction in the intake of carbohydrates
at dinner, as shown below. TABLE-US-00009 Effect of Fiber Beverages
on Carbohydrate Caloric Intake at Dinner Mean Carbohydrate Standard
P value vs. Condition Kcal Intake Error placebo Placebo 379 21 1
g fiber beverage 329 21 0.007 2.8 g fiber beverage 324 21 0.003
[0139] The 1 g beverage reduced carbohydrate intake at dinner by
50 kcal, and the 2.8 g beverage provided a 55 kcal reduction. The
reduction in carbohydrate intake at both levels was statistically
significant (p<0.01).
[0140] The fiber beverages also reduced total daily food intake,
as shown below. TABLE-US-00010 Effects of Fiber Beverages on Daily
Caloric Intake Mean Kcal Standard P value vs. Condition Intake Error
placebo Placebo 1353 64 1 g fiber beverage 1261 64 0.026 2.8 g fiber
beverage 1264 64 0.033
[0141] The 1 g fiber beverage reduced overall food intake on the
test day by an average of 92 kcal, and the 2.8 g beverage provided
a reduction of 89 kcal. The P values, determined by a post-hoc Tukey's
analysis, indicated that these results were statistically significant
(p<0.05). These results indicated the absence of compensatory
eating that could have occurred in response to the reduced dinner
caloric intake.
Example 3
[0142] Subjects were recruited from a group of individuals who
completed a 16-week weight loss trial. That weight loss trial involved
an intensive weight loss regimen including a recommendation to decrease
caloric intake by 1000 kcal per day (compared to intake prior to
beginning the trial), increasing physical activity by 500 steps
per day in each week of the trial (as measured by a pedometer),
and behavioral intervention. After completing this initial weight
loss trial, subjects volunteered to participate in an additional
weight loss trial involving a different treatment regimen. This
regimen was a fiber containing nutritional bar (or placebo) consumed
twice per day at times selected by the subject. The inclusion and
exclusion criteria for these subjects were presented in the following
table. TABLE-US-00011 Inclusion Criteria: Exclusion Criteria: Age:
20-45 years old Par-Q showing underlying disease that would require
monitoring physical activity Gender: male or female Irritable bowel
syndrome BMI of 27-35 Diabetes Healthy Gastrointestinal conditions
Malabsorption syndromes Weight loss of more than 10 pounds in 3
months prior to first weight loss trial Eating disorders (i.e.,
binge eating, purging) Currently taking medications that affect
appetite Pregnant or lactating women
[0143] The fiber bar in the second weight loss trial was an unbaked,
formed bar made of formed, crunchy bits (or crispies) with 3 grams
of alginate (Manugel DPB), agglomerated with rolled oats, raisins
and dried cranberries (for color and texture) using a syrup containing
calcium phosphate (300 mg elemental calcium), and formed into bars.
Each 30-g bar contains 100 kcal. Placebo bars were matched for taste,
texture, and calcium content, but contained no alginate. The bar
composition allowed the calcium and alginate to be kept separate
in the same form until it was consumed (the fiber was present in
the crispies, and the calcium was in the syrup that held the crispies
together). Bars were designated as "A" (placebo) or "B"
(alginate), but neither the test site nor the subject knew the identity
of the bars. The compositions of both of the bars were shown in
the following tables.
[0144] To produce a batch of crisps, the ingredients are dry blended
in a small ribbon blender. The resulting dry blend is transferred
using a feeder, e.g., a K-Tron loss-in-weight feeder, into the hopper
of an extruder e.g., a Buhler Twin Screw Extruder configured with
at least one heating unit, e.g., two Mokon barrel-heating units.
Water is added as steam to the dry blend using a barrel injection
system. A second liquid can also be introduced at variable rates
by another injector the barrel. The blend is then mixed and cooked
in the extruder. The hot pressurized product stream is forced through
a die for expansion, cut, and then conveyed by vacuum or mechanical
conveying to a fluid bed drier, e.g., Buhler fluid bed drier, and
dried to the desired moisture content. The fluid bed drier can dry
about 50 to about 100 kg/hour at temperatures from about 20.degree.
to about 110.degree. C.
Alginate Containing Bars:
[0145] Alginate Crisps TABLE-US-00012 Formula # 5981-15-15 Ingredients
% 1 Rice Flour (PGP International) 56.50 2 Alginate DPB (ISP) 31.50
3 Whey Protein Isolate BiPro (Davisco) 4.00 4 Corn Starch (Cargill)
3.00 5 Fractionated Canola Oil (Cargill Solo 1000) 5.00 Total 100.00
[0146] Bars Containing Crisps: TABLE-US-00013 # Ingredients % in
Bar 1 High Maltose Corn Syrup (Cargill) 15.64 2 MFCS (Cargill) 5.81
3 Dark Molasses (Christian Hansen) 1.02 Step 1: Weigh and cook all
above liquid at 160.degree. F. 4 Maltodextrin DE 7.5 (Cargill) 1.53
5 Fructose (Univar USA) 3.57 6 Dicalcium Phosphate Anhydrous (Chemische
3.37 Fabrik Budenheim) 7 Citric Acid (Cargill) 0.07 Step 2: Add
all dry ingredients, cook Brix to 88% 8 Canola Oil (Cargill) 0.68
9 Vanilla Flavor FJ1678 (Unger) 0.51 10 Cranberry Flavor (Comax)
0.17 Total 32.37 Step 3: Add flavors and oil, mix well and cook
gently, check Brix to 87% 11 Test Crisps 32.00 12 Rolled Oats, Thick
Rolled #3 (Grain Millers) 18.00 13 Raisins (Van Drunen) 4.00 14
Cranberry Halves (Van Drunen) 12.00 Step 4: Add syrup to dry ingredients,
mix quickly Step 5: Transfer the mass to a pan, roll flat, cool
for a minimum of 15 minutes Step 6: Cut to L 4.0'', W 1.55'' and
H 0.8'', then wrap Total 100.00
Placebo:
[0147] Placebo Crisps: TABLE-US-00014 Formula # 5981-15-25 Ingredients
% 1 Rice Flour (PGP International) 88.00 2 Whey Protein Isolate
BiPro (Davisco) 4.00 3 Corn Starch (Cargill) 3.00 4 Fractionated
Canola Oil (Cargill Solo 1000) 5.00 Total 100.00
[0148] Bars Containing Placebo Crisps: TABLE-US-00015 # Ingredients
% in Bar 1 High Maltose Corn Syrup (Cargill) 15.64 2 HFCS (Cargill)
5.81 3 Molasses, Dark (Christian Hansen) 1.02 Step 1: Weigh and
cook all above liquid at 160.degree. F. 4 Maltodextrin DE 7.5 (Cargill)
1.53 5 Fructose (Univar USA) 3.57 6 Dicalcium Phosphate Anhydrous)
(Chemische 5.00 Fabrik Budenheim) 8 Citric Acid (Cargill) 0.07 Step
2: Add all dry ingredients, cook Brix to 88% 9 Canola Oil (Clear
Valley) 0.68 10 Vanilla Flavor FJ1678 (Unger) 0.51 11 Cranberry
Flavor (Van Drunen) 0.17 Total 34.00 Step 3: Add flavors and oil,
mix well and cook gently, check Brix to 87% 12 Test Crisps (5981-15-15)
32.00 13 Rolled Oats, Thick Rolled #3 (Grain Millers) 13.00 14 Whole
Almonds (Paramount Farms) 5.00 15 Raisins (Van Drunen) 8.00 16 Cranberry
Halves (Van Drunen) 8.00 Step 4: Add syrup to dry ingredients, mix
quickly Step 5: Transfer the mass to a pan, roll flat, cool for
a minimum of 15 minutes Step 6: Cut to L 4.0'', W 1.55'' and H 0.8'',
then wrap Total 100.00
[0149] The subjects were randomized to receive one of the two treatments.
[0150] Subjects were asked to consume two bars per day, when hungry,
for a 12-week period, to track their caloric intake and physical
activity levels by using a diary, and return to the clinic monthly
for weigh-ins. Consciousness of exercise level and motivation to
increase exercise was promoted by providing subjects with pedometers
to record the number of steps taken per day. This was by intent
a low intensity weight loss counseling program, and no other intervention
or training was provided during the twelve-week trial. Results of
the trial were presented in the following table. TABLE-US-00016
Change in Weight (Pounds) at Indicated Time (versus Baseline) 4
Weeks 8 Weeks 12 Weeks Active (alginate) -2.1 -3.1 -3.7 Placebo
-0.6 -1.1 -0.2
[0151] Subjects consuming the test bar containing alginate and
calcium continued to loose weight during the 12-week monitoring
period relative to those consuming a control bar (placebo; calcium
only). The group consuming the alginate bar lost significantly more
weight than the placebo group at every weigh-in. The trend to weight
loss remained consistent for the test bar group throughout the trial,
whereas the control bar group continued the weight loss trend at
a significantly lower rate through week 8 (second weigh-in period),
and then returned very nearly to baseline weight. There was no significant
difference in exercise levels between the two groups (as determined
by the pedometer step counts).
[0152] The group receiving the active bar product lost an average
of 3.7 pounds, or 1.68 kilograms over the 12 week study. In humans
participating in a long-term weight loss program, a gram of weight
loss is generally considered to require a caloric deficit of 8 kcal;
this caloric deficit can be achieved either by reduced food consumption
or increased energy expenditure through exercise. Therefore the
cumulative caloric deficit over the 12-week study for the individuals
receiving the active bar was about 13,500 calories, or a mean daily
deficit of 160 kcal.
[0153] Considering only the weight loss observed over the first
eight weeks of treatment, the cumulative caloric deficit over eight
weeks was about 11,300 kcal, or a mean daily deficit of about 201
kcal per day.
[0154] Considering only the weight loss observed over the first
four weeks of the treatment, the cumulative caloric deficit over
four weeks was about 7,600 kcal, or about 270 kcal per day.
[0155] The weight loss program of this example was of relatively
moderate intensity, and did not require participants to undergo
extreme fasting or dieting, or extensive or intensive exercise programs.
Without being bound by theory, the inventors believe that the relatively
modest nature of this weight loss regimen permitted improved performance
of the fiber-containing bar product that was administered to facilitate
weight loss. In particular, this program did not involve a high
level of supervision or externally mediated motivation that would
cause an extensive caloric deficit, resulting in behavioral changes
so great as to otherwise obviate the appetite-reducing or food intake-reducing
activity of the composition administered. It is further contemplated
by the inventors that the weight loss program of the present invention
should be of sufficient intensity to result in demonstrable weight
loss over a reasonable length of program, such as about three months.
This provides motivation for the treated individual to continue
the weight loss program and continue consumption of the comestible
fiber product that is an adjuvant to the weight loss effort. Although
the amount of weight loss needed to maintain sufficient motivation
could obviously vary greatly among individuals, about one pound
per month will be appropriate for many individuals. Again, if this
caloric deficit were achieved solely be decreased food intake, a
decrease in caloric intake of about 120 kcal per day is needed to
achieve this rate of weight loss. This decreased food intake may
also be achieved by a combination of decreased food intake and increased
exercise, or solely by an increase in exercise.
[0156] Although shown and described is what is believed to be the
most practical and preferred embodiments, it is apparent that departures
from specific designs and methods described and shown will suggest
themselves to those skilled in the art and may be used without departing
from the spirit and scope of the invention. The present invention
is not restricted to the particular constructions described and
illustrated, but should be constructed to cohere with all modifications
that may fall within the scope of the appended claims.
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