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Weight Loss Patent Abstract
Compositions for enhancing satiety and weight loss in an individual,
assays for assessing a tastant for enhancing satiety and weight
loss, and methods of using the composition to suppress appetite
and enhance weight loss are provided.
Weight Loss Patent Claims
What is claimed is:
1. A satiety enhancing composition, consisting essentially of:
an amount of at least one tastant in combination with a carrier,
and optionally with an anti-caking agent, a coloring agent, or both,
which amount is effective to effect an average weight loss of about
5 lbs. or more over an about 6-month period, when the composition
is applied to and ingested with a foodstuff on a daily basis over
the about 6-month period.
2. A method for enhancing weight loss in a person, comprising the
steps of: administering a foodstuff to the person for ingestion
on at least a daily basis for an about 6-month period to cause an
average weight loss in the person of about 5 lbs. or more over the
6-month period, the foodstuff comprising an effective amount of
a satiety enhancing composition comprising a tastant to effect said
weight loss when ingested daily by the person over the 6-month period.
3. The method of claim 2, wherein the tastant comprises a primarily
sweet tastant.
4. The method of claim 3, wherein the tastant is selected from
the group consisting of almond, anise, carob, cinnamon, cocoa, malt,
peanut, pecan, pistachio, peppermint, spearmint, apple, banana,
fig, kiwi, orange, peach, raisin, raspberry, strawberry, and mixtures
thereof.
5. The method of claim 2, wherein the tastant comprises a primarily
salty tastant.
6. The method of claim 5, wherein the tastant is selected from
the group consisting of artichoke, asparagus, avocado, basil, broccoli,
celery seed, cucumber, fennel, garlic, horseradish, mushroom, mustard,
onion, parmesan, pizza, ranch, spinach, taco, white cheese, yellow
cheese, and mixtures thereof.
7. The method of claim 2, wherein the composition effects a body
weight loss of about 5 lbs. or more over an about 6-month period.
8. The method of claim 2, wherein the administering step comprising,
during a first month, combining each primarily salty food to be
ingested with a first satiety enhancing composition comprising a
first primarily salty tastant; and during a second month, combining
each primarily salty food to be ingested with a second satiety enhancing
composition comprising a second primarily salty tastant.
9. The method of claim 2, wherein the administering step comprising,
during a first month, combining each primarily sweet food to be
ingested with a first satiety enhancing composition comprising a
first primarily sweet tastant; and during a second month, combining
each primarily sweet food to be ingested with a second satiety enhancing
composition comprising a second primarily sweet tastant.
10. A method for enhancing weight loss in an individual, comprising
the steps of: providing a satiety enhancing composition consisting
essentially of a tastant, a carrier, and optionally an anti-caking
agent, a coloring agent, or both; the tastant selected from the
group consisting of a primarily salty tastant or a primarily sweet
tastant; combining an effective amount of the satiety enhancing
composition with a food to form a foodstuff, wherein a composition
comprising a primarily salty tastant is combined with a primarily
salty food, and a composition comprising a primarily sweet tastant
is combined with a primarily sweet food; and administering the foodstuff
to the individual for ingestion.
11. The method of claim 10, further comprising selecting the tastant
based on a food to be ingested and effectiveness of the tastant
to enhance weight loss, wherein a primarily salty tastant is selected
for a primarily salty food and a primarily sweet tastant is selected
for a primarily sweet food.
12. The method of claim 10, further comprising formulating the
satiety enhancing composition in a dry powered form, by combining
the tastant, a carrier, and optionally the anti-caking agent, coloring
agent, or both.
13. The method of claim 10, wherein the combining and administering
steps are conducted with each food to be ingested by the individual
on a daily basis to effect an average weight loss of about 5 lbs.
or more over an about 6-month period.
14. A method of promoting weight loss, comprising the steps of:
administering to an individual for ingestion on a daily basis, a
foodstuff comprising a food combined with an effective amount of
a satiety enhancing composition to effect an average weight loss
of about 5 lbs. or more over an about 6-month period; wherein a
satiety enhancing composition comprising a primarily salty tastant
is combined with a primarily salty food, and a satiety enhancing
composition comprising a primarily sweet tastant is combined with
a primarily sweet food.
15. A method of enhancing weight loss, comprising the steps of:
administering with each food to be ingested by an individual on
a daily basis for an at least one month period, an effective amount
of a satiety enhancing composition consisting essentially of a tastant,
a carrier, and optionally an anti-caking agent, a coloring agent,
or both, to effect an average weight loss of about 5 lbs. or more
over an about 6-month period; wherein a satiety enhancing composition
comprising a primarily salty tastant is combined with a primarily
salty food, and a satiety enhancing composition comprising a primarily
sweet tastant is combined with a primarily sweet food.
16. A method of assaying a tastant for effecting weight loss of
an individual, comprising: selecting a tastant based on a food to
be ingested, the tastant selected from the group consisting of a
primarily salty tastant or a primarily sweet tastant; formulating
a composition consisting essentially of the tastant, a carrier,
and optionally an anti-caking agent, a coloring agent, or both;
combining the composition with each food to be ingested by an individual
to form a foodstuff; wherein a composition comprising a primarily
salty tastant is combined with a primarily salty food, and a composition
comprising a primarily sweet tastant is combined with a primarily
sweet food; administering each of said foodstuffs to the individual
for ingestion; repeating the combining and administering steps on
a daily basis for an at least one month period; and assessing the
effectiveness of the composition to effect weight loss according
to a change in weight of the individual.
17. The method of claim 16, wherein the tastant is selected for
effectiveness in effecting weight loss based on an average weight
loss of about 0.5 lb. or more per month over an about 6-month period.
18. A foodstuff, comprising a food combined with an effective amount
of the satiety enhancing composition of claim 1.
19. An article of manufacture, comprising: a unit amount of the
satiety enhancing composition of claim 1, contained within a packaging
material.
Weight Loss Patent Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional
Application Serial No. 60/334,401, filed Nov. 30, 2001.
FIELD OF THE INVENTION
[0002] The present invention relates generally to appetite suppression
and weight loss, and more particularly to a composition that enhances
satiety during a meal and methods of using the composition to achieve
body weight loss.
BACKGROUND OF THE INVENTION
[0003] With a third to a quarter of the American population overweight,
obesity is rampant in contemporary society. At any given time, 40%
of women and 24% of men are trying to lose weight and of these,
84% of women and 76-78% of men are dieting for this purpose. In
the USA, losing weight has become a national obsession. Over 30
billion dollars are spent each year devising a plethora of new diets
and methods for losing weight, none of which have been demonstrated
to be effective over a long term (2 years).
[0004] Obesity is one of the most pervasive health problems in
our society. The physical and psychological consequences have an
impact on the afflicted in countless ways.
[0005] Almost all overweight people suffer derision and ridicule,
but the worst prejudice is reserved for and directed towards obese
women. We need only look at television commentators, politicians,
and other public life to realize that overweight men do not experience
the same degree of discrimination that obese women suffer.
[0006] States of hunger and satiety are known to be of crucial
importance in the regulation of weight, and the perception of hunger
is multivariate; environmental stimuli, psychological substrate,
and internal physiology all contribute a share. Everyday experiences
attest to the influence of ambient aromas on our appetites; we salivate
at the smell of freshly baked cookies and feel nauseated at a whiff
of sewer gas. When we are hungry, foods smell better and therefore,
taste better. Conversely, olfactory ability wanes when we are satiated,
lessening the hedonics of further ingestion.
[0007] Anatomic connections of the olfactory bulb to the ventromedial
nucleus of the hypothalamus, the satiety center, authenticate these
observations, as does the presence of cholecystokinin, a gastic
satiety factor, as a neurotransmitter in the olfactory bulb. The
fact that patients with acute anosmia often gain weight suggests
that a failure of the olfactory-satiety feedback mechanism may be
involved.
[0008] In a study to assess the effect on inhalation of certain
aromas upon weight control, overweight subjects were given an inhaler
containing a blend of odorants and instructed to inhale three times
in each nostril whenever feeling hungry. New inhalers containing
a new blend of odorants were supplied each month over a period of
six months. Data indicated that those subjects with normal olfactory
abilities and who inhaled certain odorants, used their inhalers
frequently, ate two to four meals a day, felt bad about overeating
but not about themselves, lost nearly five pounds or two percent
of body weight per month over the six-month period.
[0009] This procedure has several drawbacks including the need
and inconvenience of using an inhaler prior to a meal to inhale
the odorants, the conspicuous nature of the inhaler, and the need
to carry the inhaler around.
[0010] Therefore, it would be desirable to provide a more effective
and convenient appetite suppression technique.
SUMMARY OF THE INVENTION
[0011] The present invention relates to a composition for enhancing
satiety, assays for assessing a tastant for enhancing satiety, and
methods of using the composition to suppress appetite.
[0012] The invention is based, in part, on the discovery of a specific
role for tastant substances in appetite suppression and body weight
loss.
[0013] In one aspect, the invention provides a satiety enhancing
composition. The composition comprises a tastant, which when applied
to or admixed with food, is effective to enhance satiety (i.e.,
feeling of fullness), resulting in reduced food (caloric) intake
during the meal. The satiety enhancing composition is preferably
a dry, free-flowing powder form that can be sprinkled onto a foodstuff
to be consumed. In one embodiment, the satiety enhancing composition
comprises a primarily sweet tastant. In another embodiment, the
composition comprises a primarily salty tastant. The tastant type
is preferably used in conjunction with foodstuffs most appropriate
to that taste type.
[0014] In another embodiment, the satiety enhancing composition
comprises an amount of at least one tastant in combination with
a carrier, and optionally with an anti-caking agent, a coloring
agent, or both, which amount is effective to effect an average weight
loss of about 0.5 lb. or more per month over an about 6-month period,
when the composition is applied to and ingested with a foodstuff
on a daily basis over the about 6-month period.
[0015] In another aspect, the invention may provide a method of
enhancing satiety and suppressing appetite. In one embodiment, the
method comprises applying a satiety enhancing composition to a foodstuff,
the composition comprising an amount of a tastant which, when applied
to a foodstuff and ingested, is effective to reduce caloric intake
during a meal; and administering the food to a person for ingestion.
In another embodiment, the method comprises selecting a satiety
enhancing composition comprising a tastant; applying the satiety
enhancing composition to a foodstuff; and administering the foodstuff
to an individual for ingestion. In yet another embodiment, a method
for controlling appetite in an individual includes selecting a tastant
based on a foodstuff to be ingested and effectiveness of the tastant
to enhance satiety; preparing a satiety enhancing composition comprising
an amount of the tastant effective to reduce appetite when applied
to and ingested with a foodstuff; applying an effective amount of
the satiety enhancing composition to the foodstuff; and administering
the foodstuff to a subject for ingestion, wherein the intake of
food by the subject is reduced.
[0016] In another embodiment, a method for promoting weight loss
in a person involves applying a satiety enhancing composition to
a food to be ingested, the amount of tastant in the composition
effective to cause a reduction in the intake of food by the person;
and administering the food to the person for ingestion. The effect
of the satiety enhancing composition can be measured, for example,
by a reduction in body weight over a set time period, for example
a 1-month period. Preferably, the application of the satiety enhancing
composition to foodstuffs on a daily basis will effect a body weight
loss of at least about 0.5 pound (lb.) per month, preferably at
least about 1 lb. per month, preferably at least about 3 lbs. per
month, to up to about 5 lbs. per month, preferably up to about 10
lbs. per month, preferably up to about 15 lbs. per month, and preferably
about 5 lbs. to up to about 20 lbs. over an initial 6-month period,
preferably up to about 25 lbs., preferably up to about 35 lbs.
[0017] In yet another embodiment, a method of promoting weight
loss according to the invention involves combining an effective
amount of a satiety enhancing composition with substantially each
food portion to be consumed, on a daily basis over a one-month period,
the composition comprising either a primarily sweet tastant or a
primarily salty tastant as appropriate to the food type, and preferably,
the same two tastant compositions being used over the month period,
to effect a monthly weight loss of at least about 0.5 lb. to up
to about 15 lbs. and, optionally, continuing such application of
a satiety enhancing composition to substantially each food portion
to be consumed over consecutive one-month periods for up to 6-months
or longer to effect an about 5 lb. to an about 35 lb. weight loss
over an about 6-month period, wherein the two compositions (i.e.,
comprising a primarily salty tastant or primarily sweet tastant)
utilized during a subsequent one-month period comprise different
tastants than the two compositions utilized in the preceding one-month
period.
[0018] In another aspect, the invention provides a foodstuff comprising
a food combined with a satiety enhancing composition according to
the invention. In one embodiment, the foodstuff comprises an admixture
of a primarily sweet food, and an amount of a satiety enhancing
composition comprising a primarily sweet tastant effective to enhance
satiety and/or suppress appetite resulting in reduced food intake
upon ingestion of the foodstuff. In another embodiment, the foodstuff
comprises an admixture of a primarily salty food and an effective
amount of a satiety enhancing composition comprising an effective
amount of a primarily salty tastant.
[0019] In yet another aspect, the invention provides a method for
assaying tastants for a satiety enhancing effect and appetite suppression,
or weight loss enhancing effect, when applied to or admixed with
a foodstuff and ingested. In one embodiment, the assay method comprises
selecting a tastant; formulating a composition consisting essentially
of the tastant, a carrier, and optionally an anti-caking agent,
a coloring agent, or both; applying an amount of the composition
to a foodstuff; administering the foodstuff to the individual for
ingestion; and assessing the effectiveness of the composition to
reduce caloric intake during meals as measured, for example, by
a reduction in body weight.
[0020] In another embodiment, a method of assaying a tastant for
effecting weight loss of an individual, comprises the steps of:
selecting a tastant based on a food to be ingested, the tastant
selected from the group consisting of a primarily salty tastant
or a primarily sweet tastant; formulating a composition consisting
essentially of the tastant, a carrier, and optionally an anti-caking
agent, a coloring agent, or both; combining the composition with
each food to be ingested by an individual to form a foodstuff; wherein
a composition comprising a primarily salty tastant is combined with
a primarily salty food, and a composition comprising a primarily
sweet tastant is combined with a primarily sweet food; administering
each of said foodstuffs to the individual for ingestion; repeating
the combining and administering steps on a daily basis for an at
least one month period; and assessing the effectiveness of the composition
to effect weight loss according to a change in weight of the individual.
A preferred tastant is one that effects an average weight loss of
about 0.5 lb. or more per month over an about 6-month period.
[0021] In another aspect, the invention provides an article of
manufacture. In one embodiment, the article of manufacture comprises
a unit amount of the satiety enhancing composition according to
the invention contained within a packaging material, optionally
with instructions for the use of the composition to enhance weight
loss, or enhance satiety or suppress appetite for a resultant body
weight loss, for example.
DETAILED DESCRIPTION OF THE INVENTION
[0022] In the current application, the term "tastant"
is generally understood to include substances having a flavor quality
(i.e., salty, sweet, sour, bitter) combined with an aromatic quality.
All percentages are by weight based on the total composition, unless
otherwise indicated.
[0023] The satiety enhancing composition of the invention can be
formulated with one or more "sweet" tastants that impart
a sweet taste, or one or more "salty" tastants that impart
a salty or non-sweet taste. Examples of sweet tastants that can
be used to achieve the benefits of the invention include almond
(benzaldehyde), anise, carob, cinnamon, cocoa (natural cocoa nibs),
malt, peanut (roasted), pecan, pistachio (natural), peppermint,
spearmint, and fruit type tastants including apple (natural apple),
banana, fig, kiwi, orange (sweet orange peel) peach, raisin, raspberry
and strawberry, and the like, and mixtures or blends thereof. Examples
of salty tastants that can be utilized according to the invention
include artichoke, asparagus, avocado, basil, broccoli, celery seed,
cucumber, fennel, garlic, horseradish, mushroom, mustard (seed),
onion, parmesan, pizza, ranch, spinach, taco, white cheese (e.g.,
Romano), yellow cheese (e.g., cheddar), and the like, and mixtures
or blends thereof.
[0024] The tastant can be a naturally-derived material or synthetically
produced, according to methods known and used in the art. The tastant
can be derived from concentrating the flavor components (extracts)
of naturally occurring plants and herbs, and parts thereof. For
example, the tastant can be extracted with a solvent (e.g., an alcohol/water
mixture), and the extractant dried by spray drying or evaporation.
The tastant can comprise a blend of natural or synthetic flavors.
[0025] Examples of formulations for the composition include crystalline,
microcrystalline, particles, granules, powder, spray-dried, lyophilized,
and the like, forms that will admix with a foodstuff to which it
is applied, and dissolve or undergo disintegration or dissolution
in the presence of fluids in the mouth, stomach and/or intestine.
Preferably, the composition is in the form of a free-flowing powder
or granules, and contains less than about 5 wt- % of moisture. The
composition can also be in the form of an oil which is sprayed onto
a carrier such as magnesium carbonate.
[0026] In a preferred form, the satiety enhancing composition is
a powder or granular mixture of the tastant and a suitable finely
divided solid (powder, granules) base or carrier, which is odorless
and tasteless, compatible with other ingredients of the formulation,
and not harmful to the recipient. Examples of such carriers include
maltodextrin, dextrin, starch, methylcellulose, sodium carboxymethylcellulose,
lactose, and the like, with maltodextrin being preferred.
[0027] The composition can further include an anti-caking agent
such as tricalcium phosphate, and silicon dioxide (e.g., Flo-Gard
AB silica), preferably in an amount of up to 2% by weight, based
on the total weight of the composition. A compatible colorant and
suitable for food (e.g., FD&C dyes) such as FD&C Yellow
#5 (Alum Lake 24-28%) and carmine (Alum Lake based on carminic acid),
can also be added, preferably in an amount of about 0.5% by weight
or less, based on the total weight of the composition.
[0028] Other additives and adjuvants that can be included in the
composition include effective but minor amounts of preservatives
such as ascorbic acid and sodium ascorbate; and anti-microbial agents
such as sodium benzoate, potassium benzoate, potassium sorbate,
parabens, and the like.
[0029] The satiety enhancing composition can be prepared by dry
mixing a solid form (e.g., powder or granules) of the tastant with
a finely divided solid carrier, and optional ingredients as desired.
The components of the composition can be admixed as is known in
the art and formulated according to standard procedures. Preferably,
each of the components of the composition is a FDA-GRAS approved
food additive.
[0030] The satiety enhancing composition generally comprises the
tastant in an amount of about 50% by weight up to about 99.98% by
weight, based on the total weight of the composition. Typically,
the tastant is included in an amount of about 50% to about 60% by
weight, with the balance being a carrier and, optionally as desired,
minor but effective amounts of an anti-caking agent and/or coloring
agent. The amount of the tastant in the composition depends, at
least in part, on the form of the tastant, and the strength of the
desired taste, and the hedonic quality of the tastant. The composition
generally comprises 0 to up to 0.5% by weight coloring agent, typically
about 0.01% to about 0.03% by weight when included, and 0 to up
to about 2% by of an anti-caking agent, typically about 0.5% to
about 1% by weight when included, and about 40% to about 50% by
weight carrier, based on the total weight of the composition. An
exemplary satiety-enhancing composition comprises about 50% to about
60% by weight tastant (dry powder form), about 40% to about 50%
by weight maltodextrin (granulated), 0 to about 1% by weight tricalcium
phosphate, and 0 to about 0.03% by weight colorant, based on the
total weight of the composition.
[0031] The satiety enhancing composition can be conveniently provided
in discrete packaged amounts, for example, an amount to be used
in a daily intake of food, or over a 1-month period of time. For
example, the composition can be packaged as a powder form in hard
or soft gelatin capsules, cartridges, blister packages, envelopes,
tubes, vials, ampoules, bottles, lidded cylinders, a shaker-type
container with holes for dispensing the composition, among other
containers.
[0032] The amount of the tastant in a composition required for
use in enhancing satiety may be varied or adjusted according to
the particular application, the potency of the tastant selected,
and the taste and olfactory threshold of the individual. An amount
of the composition applied to each portion of food to be ingested
in a day is effective in diminishing appetite and enhancing satiation,
resulting in reduced calorie intake during the meal, as evidenced
by body weight loss over a set time period. In general, a sufficient
amount of the composition to provide the benefits of the invention
for an average adult human is in an amount of about {fraction (1/16)}
tsp. to about 1 tsp. or more, typically about {fraction (1/16)}
tsp. up to about 1/2 tsp., per about 8 oz. of food (wet or dry weight),
depending on the particular application. On average, an adult person
consumes up to about 20 meals or snacks per day, and the composition
is preferably applied to each food portion that is eaten on a daily
basis. The upper amount of the composition that is added to the
a food portion is generally limited by the taste preference and
tolerance of the individual.
[0033] In use, a satiety enhancing composition comprising a tastant
most appropriate to the taste type of the foodstuff (i.e., sweet
or salty) is applied to (e.g., sprinkled onto), and optionally admixed
with, the foodstuff, which is then consumed. Either a composition
comprising a primarily salty tastant or tastant blend or a composition
comprising a primarily sweet tastant or tastant blend can be used,
depending on whether the foodstuff to be consumed is classified
as a primarily "sweet" food or "salty" (non-sweet)
food. The satiety enhancing composition is applied to or admixed
with the foodstuff in an amount effective to extend the satiation
effect of that foodstuff, and achieve appetite suppression and a
reduction in caloric intake.
[0034] Examples of primarily "sweet" edible foodstuffs
include sweet baked goods, cake, pudding, cookies, candy, pies,
and the like. Examples of primarily "salty" edible foodstuffs
include breads, baked goods, meats, poultry, seafood, stews, casseroles
or baked dishes, potatoes, vegetables, cereal, potato chips, cheese
curls, pretzels, crackers, and the like.
[0035] The satiety enhancing composition taken orally with a foodstuff
results in the individual being satiated with a lower caloric intake.
The satiety enhancing composition can be used with a weight loss
program or diet to reduce appetite for food, and/or as a weight
loss maintenance system. Preferably, the ingestion of the satiety
enhancing composition with the foodstuff effectively suppresses
food intake by about 10% to about 30%, which can be demonstrated
by an associated body weight reduction over a set time period, for
example, a 1-month period or more, over which a weight loss of about
0.5 lb. to up to about 5 lbs. or more per month can occur, preferably
about 1 lb. to up to about 10 lbs. or more per month, preferably
about 3 lbs. to about 15 lbs. per month, and up to about 20 lbs.
over a 6-month period, preferably up to about 25 lbs., preferably
up to about 35 lbs. over a 6-month period.
[0036] In a preferred use of the satiety enhancing composition
to promote weight loss, a set of two satiety enhancing compositions
are utilized continuously over a one-month period, the first comprising
a primarily sweet tastant, and the second comprising a primary salty
tastant, and applied to each food item that is consumed on a daily
basis over the one-month period. Preferably, the procedure is continued
over consecutive months, preferably up to at least about 6 months,
utilizing a different set of two compositions containing a different
sweet tastant or salty tastant than the preceding month. Preferably,
such application of the compositions results in a body weight loss
of at least about 0.5 lb. per month, preferably at least about 1
lb. per month, preferably at least about 3 lbs. per month, to up
to about 5 lbs. per month, preferably up to about 10 lbs. per month,
preferably up to about 15 lbs. per month, and about 5 lbs. to up
to about 35 lbs. over an about 6-month period. The same set of compositions
is preferably utilized over an entire month period. As such, a tastant
not traditionally used on a particular foodstuff can be applied.
For example, a peppermint tastant can be combined with a breakfast
cereal, or a horseradish tastant with pizza, etc.
[0037] The satiety enhancing composition can be provided as an
article of manufacture comprising a unit amount of the composition
contained within the packaging material, wherein the composition
comprises a tastant or blend of tastants in an amount effective
to enhance satiety or suppress appetite. The packaging material
is preferably a water impervious material. Exemplary packaging materials
include a box, cylinder, cartridge, vial, ampoule, container with
openings (covered) for dispensing the composition (i.e., a shaker),
bottle, tube, blister package, envelope, hard or soft gelatin capsules,
and the like. The packaging material includes instruction means
that indicate that the satiety enhancing composition can be mixed
with food and consumed to enhance satiety or suppress appetite.
Suitable instruction means include printed labels, printed package
inserts, tags, cassette tapes, CDs, computer discs, and the like.
EXAMPLE 1
[0038] An open label study can be conducted as follows to assess
the effect of individual tastants to induce body weight loss of
an individual participant. An exemplary study group can include
15,000 adults based on the following criteria.
[0039] Inclusion/Exclusion Criteria
[0040] Inclusion criteria can be as follows:
[0041] 1. Beyond ideal weight and not obese (body mass index (BMI)
less than or equal to 30 kg/m.sup.2) (Mokdad et al., The continuing
epidemics of obesity and diabetes in the United States, JAMA 286:1195-1200
(2001)).
[0042] 2. Age 18-64
[0043] 3. Likes to eat between meals
[0044] 4. Does not exercise on a regular basis
[0045] 5. Likes pickles or ice cream (separately)
[0046] Exclusion criteria can be as follows:
[0047] 1. Pregnancy
[0048] 2. Planning to become pregnant in the next 6 months.
[0049] 3. Breast feeding
[0050] 4. Perceived poor ability to taste
[0051] 5. Uncontrolled hypertension, diabetes, or Sjorgren's syndrome
[0052] The following satiety enhancing composition can be formulated
with tastants in the amounts indicated.
1TABLE 1 % by Composition Tastant weight Natural Apple Flavor Blend
natural apple flavor (Sensient)) 60 Roasted Peanut Flavor Blend
natural and artificial peanut butter flavor, powder (Gold 60 Coast)
natural peanut flavor (Sensient) 2 Raspberry Burst Flavor Blend
natural and artificial raspberry flavor (Gold Coast) 50 Blended
Cinnamon Flavor artificial cinnamon flavor, powder (Flavor Concepts)
50 Pistachio Flavor Blend natural and artificial pistachio flavor
(Sensient) 60 Cool Spearmint Flavor Blend natural and artificial
spearmint flavor (Gold Coast) 50 Rich Cocoa Flavor Blend natural
cocoa nibs flavor, powder (Carmi Flavor) 50 Banana Shake Flavor
Blend natural and artificial banana flavor (Gold Coast) 50 Horseradish
Kick Flavor Blend natural horseradish powder (SpiceTec-USF) 70 Supreme
Garlic Flavor Blend natural garlic flavor (Sensient) 60 Sharp Cheddar
Cheese Flavor natural and artificial cheddar cheese flavor (Gold
60 Blend Coast) Romano Cheese Flavor Blend natural and artificial
Romano cheese flavor (Gold 60 Coast) Yellow Onion Flavor onion powder
99.975 Sharp Cheddar Cheese natural and artificial cheddar cheese
flavor (Gold 50 Coast) Sweet Apple Flavor natural apple flavor powder
WONF (Carmi Flavor) 65
[0053] Methodology
[0054] A demographic questionnaire that documents, for example,
age, race, sex, marital status, religion, employment status, alcohol
consumption, smoking habits, drug usage, food preferences, eating
habits, and so forth, can be completed by each participant.
[0055] Tastants and other ingredients of the tastant compositions
are preferably FDA/GRAS approved. Compositions comprising an individual
tastant or blends of tastants can be packaged in individual containers
and labeled as either "salty" or "sweet", and
coded such that the identity of tastant (or blend) in the composition
is not revealed to the participant.
[0056] Each month, a participant can be given a one-month supply
of two different satiety enhancing compositions, one containing
a primarily sweet tastant (or blend thereof), and one containing
a primary salty tastant (or blend thereof). The participant can
be instructed to, each day, sprinkle an amount of the composition
on all food, similar to how she/he would use salt or sugar, using
a sweet tastant composition on primarily sweet foods, and a salty
tastant composition on primarily salty foods. Participants can be
told not to deviate from their usual diet and exercise habits. Two
new test compositions can be provided each month for a period of
6 months. On initiation, subjects can complete written questionnaires
regarding height and weight, hedonics (i.e., food preferences),
demographics, and outlook (self-perception). The participants can
be weighed monthly. Each month, two new tastant compositions can
be provided, a questionnaire on weight, hedonics and outlook can
be completed, and weight loss can be assessed as it relates to the
tastants being tested and hedonics for the tastants.
[0057] The particular tastant composition, and frequency of the
use of the compositions can be correlated with the amount of weight
loss. Data can be analyzed, for example, using Pearson Correlation
coefficients and I tests. Data can also be analyzed using Signed
Rank Test, Wilcoxin Rank Sum Test, and Spearman's Rank Correlation
Coefficient (T. Colton, Statistics in Medicine, Little Brown &
Co., Boston, Mass. (1974); E. L. Lehmann, Nonparametrics: Statistical
Methods Based on Ranks, Holden-Day, New York, N.Y. (1975)).
[0058] The expected results are a reduction in body weight and
increase in self-esteem for the participant. In addition, the effectiveness
of the different tastants that are tested can be assessed and rated.
EXAMPLE 2
[0059] An open label study was conducted according to the protocol
described in Example 1.
[0060] The Test Group included 92 adults: 73 females (79%) and
19 males (21%).
[0061] The Control group included 100 adults: 75 females (75%)
and 25 males (25%).
[0062] Demographics. Each of the participants initially filled
out a questionnaire regarding age, race, height, weight, amount
of exercise per day and food preferences. The participants weighed
themselves, and their body mass index was determined.
[0063] For the Test Group participants, the age range was 18 to
64 years old, with an average of 48 years of age. Race was reported
as 74 Caucasians (80%), 14 African Americans (15%), 2 Hispanic (2%),
and 2 "Other" (2%). The average amount of exercise per
day was 15 minutes. The weight of the participants ranged from 130
to 348 pounds, with the average initial weight being 197 pounds.
The body mass index (BMI) of the participants ranged from 25 to
49, with the average being a BMI of 31.
[0064] For the Control Group participants, the average initial
weight was 192 lbs. and the average body mass index (BMI) was 30.
[0065] Protocol. Each of the Test Group participants were provided
with two tastants compositions per month for a six month period,
as shown below in Table 2.
[0066] The Test Group participants were instructed to sprinkle
an amount of the tastant composition on all food each day, similar
to how she/he would use salt or sugar, using a sweet tastant composition
on primarily sweet foods, and a salty tastant composition on primarily
salty foods. The participants weighed themselves monthly, and completed
a questionnaire on hedonics of the tastant compositions.
[0067] The Control Group participants did not ingest tastant compositions
with their food over the monitoring period.
2TABLE 2 (Test Group) Weight Change (lbs) Average Average Month
# Salty Tastant Sweet Tastant Weight Change Range Initial -- --
197 -- -- 1 Cheddar Coca Flavor 193.7 -3.3 -7 to +5 Cheese Flavor
2 Onion Flavor Spearmint 191.2 -2.5 -11 to +3 Flavor 3 Horseradish
Banana Flavor 191.1 -0.1 -7 to +6 Flavor 4 Ranch Flavor Strawberry
190.8 -0.3 -5 to +12 Flavor 5 Taco Flavor Raspberry 191.4 +0.6 -6
to +9 Flavor 6 Parmesan Malt Flavor 191.4 -0.0 -1 to +1 Flavor Final
191.4 -5.6 (-2.8%) (-34 to +6)
[0068] Results. The monthly average weight loss of the Test Group
ranged from 0 lbs. (month 6) to -3.3 lbs. (month 1). The overall
6-month average weight change of the Test Group was a loss of -5.6
lbs., or an average weight loss of about -3%.
[0069] By comparison, the overall 6-month average weight change
of the Control Group was a gain of +1.1 lbs., or an average weight
gain of +0.6%.
[0070] This indicates an average overall improvement in the Test
Group of -6.7 lbs. (from -5.6 lbs. to +1.1 lbs.).
[0071] The Test Group also had an average -2.8% change in body
mass index (from an average BMI of 31 to 28.2), while the Control
Group showed substantially no change.
[0072] Discussion. The results show that tastants (flavorants)
may be used as a way of inducing weight loss in those attempting
to lose weight, and can be integrated into a comprehensive weight
loss program.
[0073] The invention has been described by reference to detailed
examples and methodologies. These examples are not meant to limit
the scope of the invention. It should be understood that variations
and modifications may be made while remaining within the spirit
and scope of the invention, and the invention is not to be construed
as limited to the specific embodiments disclosed. The disclosures
of references cited in the application are incorporated by reference
herein.
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