Weight loss abstract
Compositions and methods of losing weight are described that are
suitable for individuals susceptible to gastric hyperacidity or
gastroesophageal reflux. The compositions include in part a snack
food having two or more rapidly digestible carbohydrates, in which
the foodstuff or an aqueous mixture of the foodstuff and water has
a pH equal to or greater than about 6, and in which the snack is
substantially protein-free. The method of weight loss suitable for
an individual with gastric hyperacidity includes substantially limiting
the individual's caloric intake to about 1400 calories or less for
women and 1800 calories or less for men in which the caloric intake
includes one or more substantially protein-free snack foodstuffs
having two or more rapidly digestible carbohydrates, in which an
aqueous mixture of the foodstuff with water has a pH equal to or
greater than about 6 and in which the individual loses weight.
Weight loss claims
We claim:
1. A method of weight loss for a male individual comprising consuming
a foodstuff which comprises two or more rapidly digestible carbohydrates,
which foodstuff or a mixture thereof with water has a pH equal to
or greater than about 6, which foodstuff is substantially free of
protein, and substantially limiting a daily caloric intake of said
male individual to about 1800 calories or less, whereby said male
individual loses weight.
2. A method of weight loss for a female individual comprising consuming
a foodstuff which comprises two or more rapidly digestible carbohydrates,
which foodstuff or a mixture thereof with water has a pH equal to
or greater than about 6, which foodstuff is substantially free of
protein, and substantially limiting a daily calorie intake of said
female individual to about 1400 calories or less, whereby said female
individual loses weight.
3. A method of weight loss for an individual comprising consuming
a foodstuff which comprises two or more rapidly digestible carbohydrates,
which foodstuff or a mixture thereof with water has a pH equal to
or greater than about 6, which foodstuff is substantially free of
protein, whereby the foodstuff is a replacement for one or more
meals or snacks and said individual loses weight.
4. A method of weight loss for an individual, wherein said individual
suffers from gastric hyperacidity or gastroesophageal reflux, comprising
consuming a foodstuff which comprises two or more rapidly digestible
carbohydrates, which foodstuff or a mixture thereof with water has
a pH equal to or greater than about 6, which foodstuff is substantially
free of protein, whereby said individual loses weight.
5. A method of weight loss for an individual comprising consuming
a foodstuff which comprises two or more rapidly digestible carbohydrates,
which foodstuff or a mixture thereof with water has a pH equal to
or greater than about 6, which foodstuff is substantially free of
protein, and consuming about 90% of daily protein at breakfast and
lunch, whereby the individual loses weight.
6. A method of weight loss for an individual comprising consuming
a foodstuff which comprises two or more rapidly digestible carbohydrates,
which foodstuff or a mixture thereof with water has a pH equal to
or greater than about 6, which foodstuff is substantially free of
protein, and which foodstuff comprises about 30 40 g maltodextrin,
about 10 18 g dextrose, about 1 5 g starch, or combinations thereof,
whereby said individual loses weight.
7. A method of treating gastric hyperacidity associated with obesity
comprising consuming one or more replacement snacks as a substitute
for a meal or another snack, wherein said replacement snack or a
mixture thereof with water has a pH equal to or greater than about
6, whereby gastric hyperacidity is ameliorated.
8. The method of claim 7 in which the replacement snack comprises
two or more rapidly digestible carbohydrates, which snack is substantially
free of protein.
9. The method of claim 7 in which the pH is less than about 8.
10. A method of treating gastroesophageal reflux comprising consuming
one or more replacement snacks as a substitute for a meal or another
snack, which snack or a mixture thereof with water has a pH equal
to or greater than about 6, whereby gastroesophageal reflux is ameliorated.
11. A method of maintaining body weight comprising replacing a
conventional snack with a snack foodstuff comprising two or more
rapidly digestible carbohydrates, which foodstuff or a mixture thereof
with water has a pH equal to or greater than about 6, which foodstuff
is substantially free of protein, whereby the body weight is maintained.
12. A method of weight loss for a male individual, comprising consuming
a foodstuff which comprises two or more rapidly digestible carbohydrates
and a pH buffer, which foodstuff or a mixture thereof with water
has a pH equal to or greater than about 6, and which foodstuff is
substantially free of protein, and limiting a daily caloric intake
of said male individual to about 1800 calories or less, whereby
said male individual loses weight.
13. A method of weight loss for a female individual, comprising
consuming a foodstuff which comprises two or more rapidly digestible
carbohydrates and a pH buffer, which foodstuff or a mixture thereof
with water has a pH equal to or greater than about 6, and which
foodstuff is substantially free of protein, and limiting a daily
caloric intake of said individual to about 1400 calories or less,
whereby said female individual loses weight.
14. A method of weight loss for an individual, whereby said individual
has a gastric hyperacidity or a gastroesophageal reflux, comprising
consuming a foodstuff which comprises two or more rapidly digestible
carbohydrates and a pH buffer, which foodstuff or a mixture thereof
with water has a pH equal to or greater than about 6, and which
foodstuff is substantially free of protein, whereby said individual
loses weight.
15. A method of weight loss for an individual, comprising consuming
a foodstuff which comprises two or more rapidly digestible carbohydrates
and a pH buffer, which foodstuff or a mixture thereof with water
has a pH equal to or greater than about 6, and which foodstuff is
substantially free of protein, and consuming about 90% of daily
protein at breakfast and lunch, whereby said individual loses weight.
16. A method of weight loss for an individual, comprising consuming
a foodstuff which comprises two or more rapidly digestible carbohydrates
and a pH buffer, which foodstuff or a mixture thereof with water
has a pH equal to or greater than about 6, wherein said foodstuff
comprises about 30 40 g maltodextrin, about 10 18 g dextrose, about
1 5 g starch, or a combination thereof, and which foodstuff is substantially
free of protein, whereby said individual loses weight.
17. A method of maintaining a body weight, comprising replacing
a conventional snack with a snack foodstuff comprising two or more
rapidly digestible carbohydrates and a pH buffer, which snack foodstuff
or a mixture thereof with water has a pH equal to or greater than
about 6, and which snack foodstuff is substantially free of protein,
whereby a body weight is maintained.
18. A composition comprising about 20 100 g of a rapidly digestible
carbohydrate blend in solution and a pH buffer, wherein said solution
has a ratio of water to said carbohydrate blend of about 3 12 milliliters
of water to about 1 g of said carbohydrate blend, said solution
has a pH equal to or greater than 6, and said solution is essentially
free of protein.
19. The composition of claim 18, wherein said carbohydrate blend
comprises a galactose, a dextrose, a mannose, a sucrose, a maltose,
a lactose, a dextrin, a maltodextrin, or a mixture thereof.
20. The composition of claim 18, wherein about 60 100% of said
carbohydrate blend is a dextrose, a dextrin, a maltodextrin, or
a mixture thereof.
21. The composition of claim 18, wherein about 0 40% of said carbohydrate
blend is a starch, a pre-gelatinized starch, or a mixture thereof.
22. The composition of claim 18, wherein said solution further
comprises a compound selected from the group consisting of a vitamin,
a tryptophan, a tyrosine, an ovarian hormone, a detoxifying agent,
and a diuretic.
23. The composition of claim 18, wherein said solution contains
no more than 1 2 g of fat.
Weight loss description
FIELD OF THE INVENTION
The present invention relates to an appetite suppressant and/or
snack food composition and methods for inducing weight loss and/or
preventing weight gain suitable for individuals who may have gastric
hyperacidity.
BACKGROUND OF THE INVENTION
Individuals with gastric hyperacidity are restricted in choice
of diet. For those who are obese or who need to control their weight
for other reasons, such a restriction in food options makes desirable
weight loss yet more difficult. Further, gastric hyperacidity and
gastroesophageal reflux are thought to be associated with obesity,
as the sensation of hyperacidity is often confused with that of
hunger. Since eating relieves the discomfort, even if the person
is not hungry, eating often occurs. Thus "false hunger"
produced by the hyperacidity may cause many obese individuals to
discontinue adherence to a calorie restricted diet. S"Patients
with esophageal pH<4 for more than 5% of observed time weighed
more than those with normal acid exposure." Fisher et al. Dig
Dis Sci 1999; 44:2290, abstract only. Moreover, obese patients produce
more gastric acid in response to pentagastrin than do normal-weight
control individuals. Wisen et al. Dig Dis Sci 1987; 32: 968, abstract
only.
Obesity remains a serious health concern in modern society and
is highly correlated with medical problems including diabetes. Moreover
medical science has linked obesity with cardiac problems, high blood
pressure, and kidney ailments. Sixty-one percent of adult Americans
are overweight and more than a quarter are obese according to the
1999 National Health and Nutrition Examination survey of the Center
for Disease Control and Prevention. Obese individuals may also suffer
psychologically under constant commercial media bombardment of "beautiful"
people being skinny and svelte. Indeed, obese people often suffer
a social stigma simply from their appearance.
Improvement in a sense of well-being and health is often associated
with loss of excess weight. The anecdotal results are supported
by studies of metabolic functions in individuals on weight loss
protocols. Flechtner-Mors et al. Obesity Res 2000; 8:399. For example,
both men and women have decreases in elevated insulin and glucose
levels at three months after initiating a weight loss regimen and
coincident with weight losses of about 8% and 7%, respectively.
Ditschuneit et al. Am J Clin Nutr 1999; 69:198. Moreover, long term
decreases in elevated insulin and glucose levels have been observed.
Flechtner-Mores, supra. Both of these studies replaced one or two
meals with a meal replacement and provided nutrition snack bars
for snacks.
For both the medical and social disadvantages, overweight and obese
individuals have long sought effective methods to lose their excess
weight. While a combination of a reasonable diet and exercise may
be best, it is not uncommon for individuals to subscribe to one
diet plan after the next in a vain effort to lose weight. And, as
anyone who has tried any of the numerous diet plans available has
experienced, the craving for food while on a diet can be quite acute
and the urge to stray from the dietary regimen constant. Hence,
any one individual on a diet may not necessarily lose weight over
the course of a diet and a population of individuals on a given
diet may experience a very large range of weight change. Individuals
suffering from gastric hyperacidity are particularly restricted
in the varieties of food that they can consume.
For some individuals on a diet plan, a substitute for the commonly
available "snack" food is an aid in weight loss.
U.S. Pat. No. 5,595,772 to J. Wurtman and R. J. Wurtman titled
"Composition and Methods for Losing Weight," discloses
a snack composition "which may include maltodextrin (35 grams),
dextrose (14.5 grams), Penplus UM Starch (3.0 grams), malic acid,
fine granular (1.4 grams), H&R Orange (90 milligrams), WJ Yellow
No. 6 (30 milligrams), Niacinamide (5.0 milligrams), pantothenate
(2.5 milligrams), calcium (500 milligrams), and magnesium (200 milligrams).
The snack composition may also contain added fiber (e.g. circa 10
grams of methylcellulose or the like)."
U.S. Pat. Nos. 5,760,014 and 5,612,320, both to J. Wurtman, J.
L. Shear, and A. Kershman and both titled "Therapeutic carbohydrate
blends useful for aiding premenstrual syndrome," a composition
of 44.5 g dextrose, 3 g starch, 1.4 g malic acid, pH 2, 270 mL water,
and orange flavoring.
However, for obese patients, a majority of which have signs and
symptoms of gastric hyperacidity, too much exogenous acid is contraindicated.
SUMMARY OF THE INVENTION
Applicants have developped a snack foodstuff having a pH of 6 or
greater. In some embodiments the pH is greater than about 6 but
less than about 8. The snack foodstuff, which can be for consumption
by an individual susceptible to having gastric hyperacidity or gastroesophageal
reflux, comprises two or more rapidly digestible carbohydrates,
which foodstuff or a mixture thereof with water has a pH equal to
or greater than about 6, and which foodstuff is substantially free
of protein. In one embodiment, the snack foodstuff further comprises
one or more vitamins or minerals. The snack food an also be used
to control stress-induced overeating, wherein the individual may
or may not suffer from hyperacidity.
The snack foodstuff of the invention can be of several forms including
liquid, suspension, powder, semi-solid, and solid. Semi-solid is
meant to include custards, dessert puddings, thick creams, mousses,
parfaits, yogurts, and sweetened gelatins. Without limiting to particular
embodiments, the solid form can be prepared as a bar similar to
a energy bar, a chip, a cookie, a cracker, pasta or a puffed material,
e.g. popcorn or a rice-cake-like foodstuff. Some embodiments require
the individual to dissolve, suspend, or rehydrate the snack foodstuff.
By "a pH equal to or greater than about 6," it is meant
that the foodstuff, if a solution, has a pH equal to or greater
than about 6, or else if the foodstuff is not liquid, then a solution
or suspension of the foodstuff has a pH equal to or greater than
about 6, or alternatively the pH is measured prior to making the
ultimate form of the foodstuff by measuring the pH of the carbohydrate
mixture. The pH of the carbohydrate mixture should be at least about
6 and, when the carbohydrates are incorporated into the foodstuff
product, no additional acidic component is added, or else minimal
acidic ingredients are added so that the pH does not become less
than 6. In one aspect, the pH of the foodstuff is greater than about
6, but less than about 8.
In some embodiments, the snack foodstuff can be an appetite suppressant.
In other embodiments, the snack foodstuff can be an aid to weight
loss and/or weight control.
Moreover, Applicants have developed a method of weight loss for
an individual comprising consuming a foodstuff comprising two or
more rapidly digestible carbohydrates, which foodstuff is substantially
free of protein, whereby the individual loses weight. The method
is equally suitable for a subject having or susceptible to having,
gastric hyperacidity. In a preferred embodiment, the method further
comprises providing a diet plan in which a total caloric value is
not more than about 1400 calories for women or 1800 calories for
men, or a dietary amount for the particular individual, and in which
one or more snack foodstuffs comprise two or more rapidly digestible
carbohydrates; which foodstuff or a mixture thereof with water has
a pH equal to or greater than about 6; and in which the subject
having gastric hyperacidity loses weight. Individuals who are overweight
but not obese can also benefit from the methods of treatment of
the invention. The snack foodstuff is suitable for inclusion in
a diet plan that includes breakfast, lunch, and/or dinner.
Another embodiment of the invention is a method of treating obesity
that is suitable for a subject who could have, or actually do have,
gastric hyperacidity in which the method comprises consuming one
or more meals and one or more snack foodstuffs in which a total
daily caloric value is a dietary amount, e.g., not more than about
1400, 1600, 1800, 2,000, 2,500 or 3,000 calories depending on the
individual, in which the snack foodstuffs have a substantially protein-free
mixture of one or more vitamins, and rapidly digestible carbohydrates
including maltodextrin, dextrose, and starch; which foodstuff or
a mixture thereof with water has a pH equal to or greater than about
6, in which some or all of the meals are prepared at home; and in
which the subject having gastric hyperacidity loses weight. The
method can equally be applied for the treatment of individuals who
are overweight, but not technically obese, as well as a method for
preventing weight gain.
Preferably, the meals and snacks of the method of the invention
have a predetermined range of caloric and nutritional content. Most
preferably, the traditional foods should be chosen according to
guidelines specifying a fixed amount of protein and carbohydrate.
In accordance with the present invention, it has been surprisingly
discovered that individuals suffering from gastric hyperacidity
tolerate the compositions and methods of the invention quite well.
Moreover, the dieting individual suffered less from carbohydrate
craving, and recorded an increase in their self-reported vigor relative
to overweight individuals consuming a control diet as shown in the
examples below.
Also contemplated by the present invention is a method of treating
gastric hyperacidity associated with obesity comprising consuming
one or more replacement snacks as a substitute for a meal or a conventional
snack, which snack or a mixture thereof with water has a pH equal
to or greater than about 6, whereby gastric hyperacidity and/or
gastroesophageal reflux is ameliorated. In another embodiment, the
present invention is a method of treating gastroesophageal reflux,
which can be acidic, comprising consuming one or more replacement
snacks as a substitute for a meal or a conventional snack, which
snack or a mixture thereof with water has a pH equal to or greater
than about 6, whereby gastric hyperacidity and/or gastroesophageal
reflux is ameliorated.
Another method of the invention is the enhancement of body weight
control. The method of weight control comprises consumption of an
appetite suppressant comprising a snack foodstuff comprising two
or more rapidly digestible carbohydrates, which foodstuff or a mixture
thereof with water has a pH equal to or greater than about 6, and
which foodstuff is substantially free of protein. The individual
desirous of maintaining body weight can consume one, two, three,
or four portions of the snack foodstuff daily. The snack foodstuff
is suitable for use by an individual who can have gastric hyperacidity,
gastroesophageal reflux, gastric distress related to mild hiatus
hernia, nausea associated with gastric hyperactivity, and the like.
Yet another embodiment of the present invention is a method of
inhibiting the carbohydrate craving of an individual with gastric
hyperacidity who is participating in a weight loss diet plan under
guidelines specifying specific amounts of nutritious protein-rich
and carbohydrate-rich foods, in which a snack foodstuff is a component.
In some embodiments, the snack food compositions and methods of
losing weight can be tailored to individuals with gastric hyperacidity
and can generally address a carbohydrate craving universally complained
of by individuals on a diet, as well as increase the feeling of
well being and self-reported vigor among these affected individuals.
In this regard, the carbohydrate composition of the present invention
may also be particularly suited for use in the treatment of overeating
in individuals suffering from stress, PMS, menopausal symptoms,
"winter blues", binge eating, smoking withdrawal, alcohol
withdrawal, mild pain/itch (which is often associated with carbohydrate
craving and weight gain), sideffects of various psychotropic drugs,
and to promote sleep.
These and other objects in the present invention will become apparent
to one of ordinary skill in the art, upon further consideration
of the balance of the present disclosure, which is provided to further
assist those interested in practicing the invention.
DETAILED DESCRIPTION OF THE INVENTION
The present invention is directed to compositions and methods for
effecting weight loss such that individuals using the compositions
and methods of the invention experience minimal carbohydrate craving.
The invention is particularly suited to individuals who have, or
could have, gastric hyperacidity, although it can be equally effective
for individuals with normal or low levels of stomach acid. The invention
is also suitable for individuals who desire to lose weight and also
suffer occasional gastroesophageal reflux.
In one embodiment, the invention comprises a snack foodstuff for
consumption by an individual with gastric hyperacidity or who could
have gastric hyperacidity comprising two or more carbohydrates,
which foodstuff, an aqueous suspension thereof or an aqueous solution
thereof has a pH equal to or greater than about 6. The carbohydrates
can be any rapidly digestible carbohydrates. The composition is
also suitable for consumption by an individual who does not have
gastric hyperacidity. The snack foodstuff is useful as a component
of a weight loss regimen.
In one particular embodiment, the snack foodstuff comprises a pH
buffer such that the final formulation has a pH of about 6 or greater.
The selection of a pH buffer that would maintain the pH of the final
formulation to about 6 or greater would be known to one of skill
in the art depending on the formulation, but may be selected from
sodium phosphate, potassium phosphate, sodium citrate, sodium malate,
potassium adipate, sodium fumarate, potassium lactate, ammonium
succinate, potassium tartrate, sodium ascorbate, potassium acetate,
or sodium thylenediaminetetraacetic acid. The salts can be any salt
form, including sodium, potassium, magnesium, calcium, ammonium,
or tin. In an alternative formulation, no pH buffer is added, but
little or no exogenous acid is added to the formulation such that
the final formulation has a pH of about 6 or greater.
The foodstuff of the invention can, furthermore, comprise a fluid.
The fluid in the foodstuff of the invention can be water, fruit
juice, vegetable juice, soda (soda pop), diet soda, coffee, tea,
or combinations thereof. The water can be spring water, purified
water, mineral water, carbonated water, or tap water. The soda can
also be bicarbonated water. In one particular embodiment, the aqueous
mixture of the foodstuff of the invention with fluid has a pH greater
than about 6 but less than about 8.
The snack foodstuff of the invention is preferably a powder, a
beverage, a soup, a solid, a semi-solid, or a frozen confection.
Suitable forms of the powder include a fine powder, a medium powder,
and a coarse powder. Preferably the powder is free-flowing and readily
mixable with water or other fluid. The powder form of the snack
foodstuff can be mixed with a variety of fluids. Thus, for example,
the powder form of the invention can be mixed with water, soda,
diet soda, tea, coffee, fruit juice, diet fruit juice, flavored
diet beverages, and the like. Preferably, the powder form of the
invention is mixed with water or other fluid before drinking. The
beverage can be a still beverage or a carbonated beverage, and moreover,
can be a suspension, for example, a shake, frappe, or float. Carbonated
beverages are preferably made without phosphoric acid, to permit
a higher pH. Carbonated beverages as diluents are preferably used
with buffer formulations of the composition, such that the final
pH is greater than about 6. Both carbonated and non-carbonated beverages
can be "diet" beverages made with low calorie or no-calorie
sweetners, including saccharine, aspartame, dihydrochalcones, monellin,
steviosides, glycyrrhizin, sorbitol, mannitol, maltitol, and others.
The beverage can be an infusion or extract, including a tea or a
coffee. The solid can be a bar, much like an energy bar or a candy
bar; a chip, like a potato or corn chip in shape or texture; a baked
good; a non-baked extruded food product; a puffed snack; a cracker;
a cookie; in which the solid can be with or without embedded flavor
nuggets such as nuts, fruits, or chocolate chips. The semi-solid
snack foodstuff can be a custard, a dessert pudding, a thick cream,
a mousse, a parfait, a yogurt, a jelly, a sweetened gelatin, and
similar snacks. The frozen confection can be an "ice cream",
an "ice milk", a sherbet, a flavored ice, and similar
snacks, and can, optionally, include a wafer or cone, a stick, cup,
or flavor nuggets such as nuts and candy sprinkles (a.k.a. "jimmies").
The frozen confection should be substantially free of protein, i.e.,
less than 0.5 g. The frozen confection can be formed into any of
a variety of attractive shapes including cones, cups, bars, and
sandwiches.
The snack foodstuff can include flavorants including, but not limited
to sweet, salty, and bittersweet flavors. The flavorant can include
any flavor not requiring an acid pH or which is known to exacerbate
hyperacidity. Alternatively, a pH buffer may be used to ensure that
the final formulation has a pH of about 6 or greater. The selection
of a flavorant that alone or in combination with a pH buffer would
maintain the pH of the final formulation to about 6 or greater would
be known to one of skill in the art. More particularly, the flavors
in the snack foodstuff can be fruit flavors, nut flavors, bean flavors
(including coffee, vanilla, and chocolate), vegetable flavors, herb
flavors (including tea), flower flavors (including rose and nasturtium),
butter and cream flavors, caramel flavor, spice flavors, savory
flavors, and meat flavors. Even flavors not usually associated with
diet foods can be used, as long as the pH is maintained to about
6 or greater. The flavors can be natural, artificial, or both. Preferred
flavor combinations are vanilla, chocolate and vanilla-fruit, such
as orange or raspberry.
The composition can include natural and artificial colors as well
known in the art.
In a preferred embodiment, a one-serving snack portion of the foodstuff
of the invention comprises about 5 to 100 g of carbohydrate. In
a more preferred embodiment, the one-serving snack portion comprises
15 100 g, more preferably 45 90 g and most preferably 40 60 g.
The carbohydrate component of the snack can comprise any readily
digestible carbohydrate. In one embodiment of the invention, the
carbohydrate does not include high-fructose corn syrup. In one preferred
embodiment of the invention, the one-serving snack portion is about
30 40 g maltodextrin, about 10 18 g dextrose, about 1 5 g starch,
and/or one or more vitamins. In a yet more preferred embodiment,
a one snack portion of the foodstuff of the invention comprises
about 35 g maltodextrin, about 14 g dextrose, about 3 g starch,
and, optionally, one or more vitamins or minerals. A single serving
of the snack foodstuff can optionally include 2 g of protein, preferably
1.5 g of protein. A single serving of the snack foodstuff can also
optionally include 1 2 g of fat. Further, a single serving of the
snack foodstuff can optionally include an aqueous portion consisting
essentially of about 50 to 800 ml fluid, preferably 200 to 500 ml
fluid. More preferably, a single serving of the snack foodstuff
can include 350 to 450 ml of an aqueous fluid.
The snack foodstuff discovered by the inventors can further comprise
soluble or insoluble fiber. Suitable sources of fiber include methylcellulose,
psyllium, and bran from oats, corn, rice, barley, buckwheat, and/or
wheat.
In another embodiment, the invention is a method of weight loss
for an individual comprising consuming a foodstuff comprising two
or more rapidly digestible carbohydrates, which foodstuff, an aqueous
suspension thereof, or an aqueous solution thereof, has a pH equal
to or greater than about 6, which foodstuff is substantially free
of protein, whereby the individual loses weight. The method can
further comprise substantially limiting the individual's caloric
intake to about 1400 calories for a female individual or 1800 calories
for a male individual depending on the individual. In a preferable
embodiment, the invention is a method of weight loss for an individual
comprising consuming a foodstuff comprising two or more rapidly
digestible carbohydrates, which foodstuff, alone or combined with
water, has a pH equal to or greater than about 6, which foodstuff
is substantially free of protein, whereby the individual loses weight.
A suitable ratio of the dry snack foodstuff to water is from about
1 to 1 to about 1 to 40, preferably about 1 to 5. The individual
with gastric hyperacidity loses weight. The method is preferably
applied to individuals who are overweight or obese. More preferably,
the method is applied to individuals who have excess stomach acid,
gastric hyperacidity, or reflux of stomach contents into the esophagus.
It is envisioned that in the method of the invention, on occasion
the snack foodstuff can replace a meal in the weight loss regimen
for an individual. Alternatively, the snack foodstuff can replace
a conventional snack. The meaning of conventional snacks is well
understood by nutritionists, and can include, without limitation,
potato chips, crackers, candy bars, and sodas.
In the method of the invention, a preferable snack foodstuff is
a combination of two or more readily digestible carbohydrates. Preferably,
the snack foodstuff, or a solution of the snack foodstuff in water,
or a suspension of the snack foodstuff in water has a pH equal to
or greater than 6, where pH is understood to be the reciprocal of
the log of the hydrogen ion concentration. The water can be ordinary
tap water, distilled or purified water, or bottled water and should
have a pH of about 7. In a preferred embodiment, the snack foodstuff
of the method of the invention comprises about 30 40 g maltodextrin,
about 10 18 g dextrose, about 1 5 g starch, and, optionally, one
or more vitamins. In one embodiment, the snack food has about 35
g maltodextrin, about 14 g dextrose, about 3 g starch, and a vitamin.
Any of a number of vitamins are suitable, including vitamins A,
B1, B2, B6, B12, C, D, E, K, or combinations of these vitamins.
Minerals can be used in the snack foodstuff in addition to, or to
substitute for, vitamins. Suitable minerals include calcium, iron,
magnesium, phosphate, manganese, chromium, molybdate, selenite,
iodide, zinc, and sulfur.
The method of the invention can further comprise that meals are
prepared at home. Alternatively, or additionally, the method can
comprise that meals are prepared at a weight loss facility, or other
facility used at times for nutrition control, including, but not
limited to hospitals, clinics, and spas.
The method of weight loss can include a snack foodstuff that has
a fluid component. The fluid can be water, fruit juice, vegetable
juice, coffee, tea, or a naturally or artificially carbonated beverage.
The fluid can be naturally or artificially sweetened. The fluids
can optionally contain caffeine.
Another embodiment of the invention is a method of treating obesity
suitable for a subject having gastric hyperacidity comprising providing
a diet plan in which a total caloric value is less than about 1400
calories or more depending on the individual and comprising one
or more, preferably two, snack foodstuffs having a substantially
protein-free mixture of rapidly digestible carbohydrates; in which
an aqueous mixture of the foodstuff with water has a pH greater
than about 6; and in which the subject having gastric hyperacidity
loses weight. Preferably, the snack foodstuff has one or more vitamins.
It is preferable that the individual loses more than 0.5 kg body
weight per month. It is yet more preferable that the individual
loses more than 1 kg body weight per month. Obesity can be a body
weight greater than 10% higher than optimal body weight. In an alternative,
obesity can be a body weight greater than 20% higher than optimal
body weight. According to the current BMI (Body Mass Index) standards,
an index of 25 30 is considered overweight and an index of 30 or
greater is considered obese.
Yet another embodiment of the invention is a method of treating
obesity suitable for a subject having gastric hyperacidity comprising
consuming one or more meals and one or more snack foodstuffs in
which a total daily caloric value is less than about 1400 calories
for women and 1800 calories for men, in which the snack foodstuffs
have a substantially protein-free mixture of rapidly digestible
carbohydrates; and in which a mixture of the foodstuff with water,
or the foodstuff alone, has a pH greater than about 6. In a preferred
embodiment, the method of treating obesity further comprise that
some or all of the meals are prepared at home, or, alternatively
or additionally, at a weight loss center. In a yet more preferred
embodiment, the subject having gastric hyperacidity loses weight.
Substantially protein-free preferably means that the ratio of carbohydrate
to protein is at least 5 to 1, preferably 6 to 1, more preferably
10 to 1, and most preferably 20 to 1. A substantially protein-free
serving means that each serving has less than 5 g of protein, preferably
2 grams of protein, even more preferably 1.5 g of protein, and most
preferably, a substantially protein-free serving has less than one
gram of protein. Even more preferably, a substantially protein-free
serving has less than one-half gram of protein. Yet even more preferably,
a substantially protein-free serving has less than one-eighth gram
of protein. Most preferably, a substantially protein-free serving
of the snack foodstuff has no measurable protein.
In particular, the compositions of the present invention promote
weight loss by limiting the ratio of carbohydrate to protein in
three daily meals and in one daily snack, preferably two daily snacks,
within prescribed ranges. According to the present invention, the
breakfast and lunch composition preferably has a relatively low
carbohydrate:protein ratio, for example, 4 parts by weight carbohydrate
to 3 parts by weight protein. The dinner composition, in contrast,
contain a relatively high ratio of carbohydrate to protein, for
example, 7 parts by weight carbohydrate to one part by weight protein.
Lastly, the daily snack composition is comprised of complex and/or
simple carbohydrates, and is substantially free of protein.
As used herein, the term "carbohydrate" encompasses both
complex carbohydrates and simple sugars. Rapidly digestible carbohydrates
are used by the body without extensive hydrolysis. Thus, rapidly
digestible carbohydrates can include, but is not limited to simple
sugars, monosaccharides, disaccharides, complex sugars, linear starches,
branched chain starches, partially hydrolyzed starches, and hydrolyzed
starches. Hydrolysis can be accomplished by any method known in
the art, including acid hydrolysis, thermal hydrolysis, and enzymatic
hydrolysis. Preferably, the carbohydrate is of a high glycemic index,
such as maltodextrin, polycose (a synthetic polyglucose), dextrose,
sucrose, or maltose, to name a few. Other sources of carbohydrate
include but are not limited to, galactose, pre-gelatinized starch,
hydroxyethyl starch, corn starch, fructose, corn syrup, corn syrup
solids, molasses, honey, mannose, lactose, dextrin, and mixtures
thereof. Rapidly digestible blends of carbohydrate can likewise
be used. In particular, the rapidly digestible carbohydrate can
be corn syrup, high fructose corn syrup, starch, corn starch, uncooked
corn starch, high amylose starch, rice starch, potato starch, tapioca
starch, sweet potato starch, yam starch, cassava starch, maltodextrin,
invert sugar, honey, molasses, sucrose, fructose, lactose, glucose,
dextrose, galactose, maltose, or combinations thereof.
Readily digestible carbohydrates are produced in many ways known
to those skilled in the art. For example, maltodextrins are partial
hydrolyzates of starches. Maltodextrins and other carbohydrates
can be classified on the basis of dextrose equivalent (D.E.) values.
Starch hydrolyzates having D.E. values up to about 20 are considered
to be maltodextrins, while those having D.E. values above about
20 are considered to be corn syrups. Various methods of producing
maltodextrins are well known in the art. The maltodextrins having
a low D.E., generally are made by first liquefying native starch
with an acid or an enzyme to a D.E. less than about 15, followed
by enzymatic conversion, e.g., with bacterial alpha-amylase. Maltodextrins
are first prepared in syrup form and then spray dried to a moisture
content of 3 to 5 percent by weight.
Examples of carbohydrates which are constituted by polysaccharides
or mixtures of mono-, di- and polysaccharides are corn syrup solids,
various gums, such as xanthan gum, guar gum, carrageenan gum, arabic
gum, locust bean gum and tragacanth gum, maltodextrins, glucose
syrups, rice syrup, psyllium, pectin, corn starch (including chemically
modified and/or pregelatinized corn starch), tapioca starch, rice
starch, potato starch, wheat starch, arrowroot starch and cassava
starch.
One of skill in the art will understand that the carbohydrate or
blend of carbohydrates selected will depend on the various attributes
of the ingredients. For example, different carbohydrates will provide
energy more or less quickly and a judicious selection of same can
contribute to balancing the delivery of carbohydrate calories to
the consumer so that the energy provided is meted out over a period
of time. Impacting also on the choice of carbohydrate ingredients
is the desired flavor of the finished product. Different carbohydrates
have different perceived sweetness. As examples, a D.E. of 10, corresponding
to a maltodextrin, has a relatively low sweetness. In contrast,
fructose has a very high perceived sweetness. In addition to the
consideration of sweetness impact, the carbohydrate or carbohydrates
must be chosen for "fit" into the flavor profile of the
desired product. Finally, the carbohydrate or carbohydrates will
be selected for functionality related to texture and processing
characteristics of the desired nutritional composition; for example,
modified corn starch will be selected for thickness in a cooked,
ready-to-eat pudding. These and other factors in the selection of
appropriate carbohydrates are within the knowledge of those skilled
in the nutritional arts.
As used herein, the term "protein" includes any high
quality protein derived from an animal or plant source, and does
not include free or conjugated amino acids, amino acid derivatives,
or oligopeptides. Proteins derived from animal foods such as dairy
products or eggs are included in the meaning of "protein,"
including, but not limited to, whey, casein, or albumin.
Individuals can use the compositions and methods of the invention
in a supervised environment, such as a weight loss center or spa,
or equally well, can prepare meals at home and supplement the daily
caloric intake with the snack foodstuff of the invention. As an
example, the snack foodstuff can be a beverage, either prepared
at home or at work from a premixed powder or concentrated liquid,
or in ready-to-use form. In another preferred embodiment, the snack
is a ready-to-drink beverage.
Preferably, the compositions of the present invention are provided
in a package containing at least one snack composition, preferably
two snack compositions. Breakfast, lunch or dinner compositions
may also be provided in the package. Alternatively, the dinner meal
may be composed of traditional foods in a given range of caloric
and nutritional content. Preferably, the breakfast, lunch, and dinner
meals are low in acidity. In a particular embodiment of the present
invention, the daily caloric intake of the individual subscribing
to the weight loss plan should not exceed about 3,000 calories,
preferably about 2,500 calories, more preferably about 1800 calories,
more preferably about 1600 calories, more preferably about 1200
calories, and most preferably about 1300 1400 calories for women
and 1600 2000 calories for men, as long as the caloric intake is
a dietary amount for the particular individual. The caloric intake
can also be expressed by height, by age, by sex, by general activity
level, or by other criteria suitable to adjust caloric intake to
the individual's needs. For example, a preferable weight loss regime
for a man 178 cm in height can be 1500 calories, whereas for a man
173 cm in height, 1400 calories can be suitable. Similarly, a preferable
weight loss regime for a woman 173 cm in height can be 1400 calories,
whereas for a woman 168 cm in height, 1300 calories can be suitable.
One skilled in the art will understand how total caloric intake
can be adjusted to the characteristics of the individual.
Each composition provided in the snack package may be further comprised
of additional ingredients including, but not limited to, sources
of fat, fiber, calcium, vitamins and other minerals. The compositions
provided are preferably low in fat, however, with preferably less
than 20% of the calories provided in the composition deriving from
fat. The amount of fiber, such as methylcellulose, may also be adjusted,
but preferably provides between about 10 25 grams of fiber per day.
Likewise, other sources of soluble and insoluble fiber are suitable,
including wheat, corn, rice, and oat bran, and psyllium.
Accordingly, it is preferred that a breakfast composition have
a caloric content ranging from about 200 400 calories. The lunch
and/or dinner composition having a caloric content ranging from
about 300 500 calories, and the snack composition having a caloric
content ranging from about 150 250 calories. Excluding the optional
traditional dinner meal, the total number of calories provided in
the package containing at least breakfast composition, at least
one lunch composition, and at least one snack composition should
preferably range from about 700 to about 1050 calories. In a specific
embodiment of the present invention, the package should further
include instructions for the range in the caloric and nutritional
content of the optional traditional dinner meal.
The compositions of the present invention can be provided in any
convenient form, including but not limited to powders, liquids,
soups, food bars, snack crackers, snack chips, puddings, flavored
gelatins, mousses, custards, and shakes. The compositions can be
prepared with saturated, unsaturated, or polyunsaturated fats or
oils if needed, or with oil substitutes, including Olestra.TM..
Preferably, unsaturated oils are used for any fat. Natural and/or
artificial flavorings can also be added, including the following
flavors: almond, hazelnut, macadamia nut, chocolate, vanilla, strawberry,
apple, rum, banana, orange, mocha, coffee, etc.
An important aspect of the present invention is the discovery that
the breakfast and lunch meal compositions include most of the daily
protein intake. Hence, because the meal compositions will tend to
be high in protein, the meal compositions tend not to elevate the
Tp/Lnaa ratio found in the plasma after consumption of the snack
relative to the Tp/Lnaa ratio found in the plasma before consumption
of the meal.
On the other hand, the dinner meal should indeed prevent a decrease
in the post-consumption plasma levels of tryptophan relative to
the plasma levels of large neutral amino acids (Tp/Lnaa ratio);
that is, the dinner meal should maintain or elevate the post-consumption
Tp/Lnaa ratio in the plasma relative to the pre-consumption Tp/Lnaa
ratio, and the snack meals should elevate the Tp/Lnaa ratio relative
to the pre-consumption levels. Preferably, the post-consumption
plasma Tp/Lnaa ratio is elevated relative to the pre-consumption
plasma Tp/Lnaa ratio by about 10% or more, more preferably by 15%
or more, most preferably by about 20% to about 30% or more.
Hence, the breakfast and lunch compositions should provide about
40% or more of the daily protein intake, preferably about 50% or
more of the daily protein intake, most preferably about 60% or more
of the daily protein intake, and even more preferably up to about
100% of the daily protein intake. Therefore, consistent with the
objective of the present invention, the non-breakfast meal compositions
should maintain Tp/Lnaa ratios at a level to permit enhanced uptake
of tryptophan into the brain after the consumption of the snack.
Higher levels of tryptophan in the brain after the snack is consumed,
in turn, enhances the synthesis of serotonin in the brain which
provides an enhanced feeling of satisfaction, well being and ability
to control further food intake.
Table 1, shown below, provides an example of the daily caloric
and nutrient content contemplated by the present weight loss diet
plan for a female individual.
TABLE-US-00001 TABLE 1 Breakfast Snack Lunch Snack Dinner Total*
Calories 250 180 350 180 450 1410(a) Protein (g) 10 15 -- 25 30
-- 10 45 55 Carbohy- 22 25 45 22 25 45 70 204 210 drate (g) Fat
(g) 1 -- 3 1 9 14 Fiber/ 3 -- 8 -- + 11+ Fruit (g) *Vitamins and
Minerals: to be provided as multi vitamin/mineral pill + based on
food choices of subjects (a)salad and no calorie vegetables not
included
As one can see, of the 45 55 total grams of protein provided daily,
at least 40 g are consumed between the breakfast and lunch meals
and no protein is provided by the snack. Accordingly, according
to a preferred embodiment, the breakfast and lunch meal contribute
the major portion of the daily protein, preferably about 80 90%
of the daily protein intake, which can be distributed between both
meals with the greater amount being consumed at lunch. In addition,
the weight ratio of carbohydrate to protein in the lunch and dinner
meals is about 4 to 1, preferably 5 to 1, most preferably 7 to 1
or greater. In a preferred embodiment, the dinner meal can be mainly
carbohydrates (with vegetables), with 23% or less of the daily protein
requirements. Further, for a male individual, the caloric intake
is proportionally increased to 1800 calories daily, wherein about
60 g of protein is consumed between the breakfast and the lunch
meals.
Table 2, shown below, lists the calorie and nutrient content of
a control diet plan for a female individual which provides a total
number of calories similar to that provided by the weight loss plan
of the present invention. This control diet plan, typical of most
commercially available diet plans, contains a carbohydrate to protein
weight ratio no higher than about 3 to 1 and would provide most
of the daily protein intake after breakfast.
TABLE-US-00002 TABLE 2 Breakfast Lunch Snack Dinner Total Calories
205 327 207 568 1357 (a) Protein (g) 10 25 15 35 85 Carbohydrate
(g) 30 50 30 80 190 Fat (g) 5 3 3 12 23 Fiber (g) 10 8 -- + 18+
*Vitamins and Minerals: to be provided as multi vitamin/mineral
pill + based on food choices of subjects (a) salad and no calorie
vegetables not included
Accordingly, a test of the pre-consumption and post-consumption
Tp/Lnaa ratios of individuals subscribing to either the weight loss
plan of the present invention or the control diet plan showed a
marked difference in the post-consumption plasma Tp/Lnaa ratio relative
to pre-consumption plasma levels only in individuals subscribing
to the weight loss plan of the present invention.
Thus, a blood sample is taken from each individual 90 minutes after
consumption of test snack, which test snack had been consumed on
an empty stomach, i.e., three hours before the test lunch. The same
blood analysis is performed on blood samples taken from individuals
who had consumed the control lunch and control snack composition.
The results of the blood analyses are shown in Table 3, below.
TABLE-US-00003 TABLE 3 Pre- and Post-Consumption Plasma Tp/Lnaa
Ratios After Consuming Test or Control Snack Group Pre Post Increase
Test 0.094 .+-. 0.003 0.111 .+-. 0.004 0.017 Control 0.087 .+-.
0.006 0.086 .+-. 0.004 None
Hence, the test group experienced a significant increase in its
post-consumption plasma Tp/Lnaa ratio compared to that of the control
group, which experienced no increase in the plasma Tp/Lnaa levels.
As an apparent consequence of the higher Tp/Lnaa ratio after consumption
of the combined lunch or dinner and snack, although applicants do
not wish to be limited by this theory, the test group also experienced
a decrease in carbohydrate craving after consumption of the test
meals. Subjects filled out a weekly self-report assessing, on a
10 point scale, their cravings for protein, carbohydrate, fat fruits
and vegetables during the previous week. Only cravings for carbohydrate-rich
foods were noted. Over the entire 7 week study the average rating
of carbohydrate craving as compared to baseline decreased by 1.8
among the test subjects but did not change from baseline among the
control subjects.
Thus, the weight loss plan of the present invention provides a
statistically significant increase in the post-consumption plasma
Tp/Lnaa ratio compared to the control group, as well as a statistically
significant decrease in the carbohydrate craving of the test group
relative to the control group. Such benefits were provided by the
test compositions of the present invention, which allocated the
daily carbohydrate and protein intake differently from existing
diet plan compositions to ensure that the ratio of plasma tryptophan
to that of circulating amino acids is elevated sufficiently to increase
tryptophan uptake into the brain following consumption of the test
lunch or dinner and the test snack.
Preferably, the breakfast and lunch compositions contains a carbohydrate:protein
weight ratio of about 1:5 to about 5:1, more preferably about 1:2
to about 2:1, and most preferably about 1:1. Also, the dinner composition
should preferably contain a carbohydrate:protein weight ratio of
about 5:1 or higher, more preferably 7:1 or higher, and most preferably
10:1 or higher. The snack composition should be substantially free
of protein, as stated above, and may include complex carbohydrates,
simple sugars or both.
In a particular embodiment of the invention, the claimed package
includes a breakfast composition that has a caloric content ranging
from about 200 to about 400 calories, preferably, from about 250
to about 350 calories, and most preferably, from about 300 to about
325 calories. Its protein content can range from about 20 to about
50 grams, preferably about 25 to about 45 grams, most preferably
about 30 grams. Its carbohydrate content can range from about 20
to about 60 grams, preferably about 30 to about 50 grams, most preferably
about 40 grams. In addition, the breakfast composition of the present
invention may also provide about 0 to about 10 grams of fat, preferably,
about 0 to about 5 grams, most preferably, about 0 to about 2 grams,
and about 0 to about 20 grams of fiber, preferably, about 1 to about
15, and most preferably, about 5 to about 10 grams.
In a particular embodiment of the invention, the claimed package
includes a lunch or dinner composition that has a caloric content
ranging from about 300 to about 500 calories, preferably, from about
325 to about 475 calories, and most preferably, from about 350 to
about 425 calories. Its protein content can range from about 5 to
about 35 grams, preferably about 5 to about 30 grams, most preferably
about 10 to about 20 grams. Its carbohydrate content can range from
about 50 to about 90 grams, preferably about 60 to about 80 grams,
most preferably about 70 grams. In addition, the lunch or dinner
composition of the present invention may also provide about 0 to
about 15 grams of fat, preferably, about 3 to about 12 grams, most
preferably, about 5 to about 8 grams, and about 0 to about 20 grams
of fiber, preferably, about 1 to about 15, and most preferably,
about 5 to about 10 grams.
In a particular embodiment of the invention, the claimed package
includes a snack composition that has a caloric content ranging
from about 150 to about 250 calories, preferably, from about 175
to about 225 calories, and in one aspect from about 200 to about
225 calories. Its protein content should preferably be less than
5 g, more preferably less than 2 g, i.e., most preferably a carbohydrate
to protein ratio of 10 to 1 or greater. Its carbohydrate content
can range from about 15 to about 100 grams, in one aspect about
40 to about 60 grams, in one aspect about 45 grams and in another
aspect about 90 grams. In addition, the snack composition of the
present invention may also provide about 0 to about 5 grams of fat,
preferably, about 0 to about 3 grams, most preferably, about 0 to
about 0.5 grams, and about 0 to about 20 grams of fiber, preferably,
about 1 to about 15, and in one aspect, about 5 to about 10 grams.
Excluding the optional traditional meal, a preferred package of
the invention should provide a caloric content ranging from about
700 to about 1200 calories. Furthermore, the package of the invention
should preferably also provide instructions for the caloric and
nutritional content of an optional traditional meal to be consumed
for either lunch or dinner. With the optional traditional meal,
the total caloric intake should not exceed about 1800 calories,
preferably 1600 calories, more preferably 1400 calories, and most
preferably, 1200 calories.
The present invention also provides a method of losing weight comprising
substantially limiting an individual's daily caloric intake to no
more than about 1400 calories for women and 1800 calories for men,
which calories are provided by at least some form of carbohydrate
intake and at least some form of protein intake, provided that about
40 percent or more of the protein intake is consumed at breakfast
and lunch, preferably 50 percent, more preferably 60, most preferably
75 percent and even more preferably up to 100%.
In yet another embodiment of the invention, a method of maintaining
body weight is disclosed, comprising replacing a conventional snack
with a snack foodstuff comprising two or more rapidly digestible
carbohydrates, which foodstuff, an aqueous suspension thereof, or
an aqueous solution thereof has a pH equal to or greater than about
6, which foodstuff is substantially free of protein. After an individual
has achieved a desired body weight, that body weight can be maintained
by daily use of the snack foodstuff of the invention as a substitute
for any other snack. Thereby, the calorie and fat consumption of
the individual are controlled and limited. Maintaining body weight
is understood to mean that the range of body weight over a three
month period does not exceed 15%. Preferably, the change in body
weight over a three month period does not exceed 6%. It is understood
that extraordinary events can cause a temporary change in weight
that do not in any way detract from the usefulness of this embodiment
of the invention.
The methods of the present invention are particularly well suited
for promoting weight loss by substantially limiting an individual's
daily food intake to the contents of a package comprising a plurality
of food compositions including at least one breakfast composition,
at least one lunch or dinner composition, and at least one snack
composition, the breakfast composition comprising (a) at least one
form of carbohydrate, and (b) at least one form of protein, the
weight ratio in the breakfast composition of the total amount of
carbohydrate to the total amount of protein ranging from about 1:10
to about 1:1; the lunch or dinner composition comprising (a) at
least one form of carbohydrate, and (b) at least one form of protein,
the weight ratio in the composition of the total amount of carbohydrate
to the total amount of protein ranging from about 4:1 to about 10:1;
and the snack composition comprising at least one form of carbohydrate
and being substantially free of protein, and, optionally, a traditional
meal of a prescribed range of caloric and nutritional content to
be consumed either at lunch or dinner, the contents of the package
providing, along with the optional traditional meal, a daily caloric
intake falling within a predetermined range, say about 1200 to about
1800, preferably, about 1200 to about 1600, more preferably, about
1300 to about 1400.
And in yet another application of the present invention, a method
is provided for inhibiting the carbohydrate craving of an individual
participating in a weight loss diet plan comprising limiting substantially
an individual's daily food intake to a plurality of packaged compositions
comprising at least one breakfast composition, at least one lunch
composition, and at least one snack composition, the breakfast composition
comprising (a) at least one form of carbohydrate, and (b) at least
one form of protein, the weight ratio in the breakfast composition
of the total amount of carbohydrate to the total amount of protein
ranging from about 1:10 to about 1:1; the lunch or dinner composition
comprising (a) at least one form of carbohydrate, and (b) at least
one form of protein, the weight ratio in the composition of the
total amount of carbohydrate to the total amount of protein ranging
from about 4:1 to about 10:1; and the snack composition comprising
at least one form of carbohydrate and being substantially free of
protein, and, optionally, a traditional meal of a prescribed range
of caloric and nutritional content consistent with a dietary weight
loss plan to be consumed either at lunch or dinner, the contents
of the plurality of packaged compositions providing, along with
the optional traditional meal, a fixed daily caloric intake falling
within a predetermined range.
In another embodiment the invention comprises a method of treating
gastric hyperacidity associated with obesity comprising consuming
one or more replacement snacks as a substitute for a meal or another
snack, which snack or a mixture thereof with water has a pH equal
to or greater than about 6, whereby gastric hyperacidity is ameliorated.
Moreover, in a preferred embodiment, of the method the replacement
snack comprises two or more rapidly digestible carbohydrates, which
snack is substantially free of protein.
The following examples are further provided.
EXAMPLES
1. Weight Loss Plan
Sixty-two women weighing between 40 60 pounds above medically desirable
weight are recruited to enter a 7-week weight loss study. All the
subjects are first subjected to a 3 week run-in period in which
they received nutritional information and a low fat diet to eliminate
the effect of participation in a weight loss plan from the effect
of the weight loss intervention itself. After this three week run-in
period, the subjects are assigned randomly to one of two isocaloric
formula diets.
Both diets provided approximately 1350 calories daily. The control
diet followed the dietary guidelines and nutrient composition of
Ultra Slim Fast.RTM.. Briefly, the control diet contains approximately
3 parts carbohydrate to one part protein at every meal and snack.
The experimental/test plan of the present invention allocated the
amounts of protein and carbohydrate differently at each meal and
snack to ensure that following the lunch and dinner meals, the ratio
of plasma tryptophan to that of the circulating large neutral amino
acids is not decreased so that the ratio would be significantly
elevated following the consumption of the carbohydrate-rich snack.
The breakfast, lunch, and snack meals are provided in powder form
and reconstituted with either water, diet soda, or coffee. The dinner
meal is composed of traditional foods but the subjects are given
strict guidelines that restrict their food choices at this optional
traditional dinner meal according to the guidelines of each diet
plan. The study is carried out in a double blind format. Each of
the subjects are weighed weekly, and their blood pressure, moods,
cravings, and ability to adhere to the diet plan are monitored.
Twenty-one out of 33 subjects on the experimental diet plan are
found to complete the study, whereas 19 out of 30 are found to complete
the control diet plan. Both groups lost weight as a whole, see Table
4.
TABLE-US-00004 TABLE 4 Baseline Final Pearson's Weight Weight correlation
Experimental Diet 181 .+-. 2.62 177 .+-. 1.10 (P < 0.0001)* Control
Diet 187 .+-. 3.3 183 .+-. 1.44 (P < 0.0011)*
Changes in the mood of each subject over the 7-week study are also
monitored using the Profile of Mood States, which is a self-rating
form describing several mood states. McNair, D., et al., in Profile
of Mood States (Manual), San Diego, Calif. Educational Testing Service
(1971) pp. 5 29.
It is also found that there is a significant difference in the
overall rating of vigor between the two groups, the experimental
group rating themselves as significantly more vigorous (p<0.03)
than the control group, using an Analysis of Variance to do the
analyses.
2. Snack Food Composition
A typical snack composition (formula #1) can include maltodextrin
(35 grams), dextrose (14.5 grams), Penplus UM Starch (3.0 grams),
niacinamide (5.0 milligrams), and pantothenate (2.5 milligrams),
calcium (500 milligrams), and magnesium (200 milligrams). The snack
composition, as well as the other food compositions, may also contain
vitamins A, D, E, B-1, B-2, B-6, B-12, and/or C. The snack composition
may also contain added fiber (e.g., circa 10 grams of methylcellulose
or the like). A buffer for pH can be included to adjust natural
acidity so that the resultant pH is equal to 6 or higher.
According to a preferred embodiment, the snack food composition
has an orange/cream flavor, contains 182.2 calories, including 2.4
calories from fat, and includes 63.48 g of carbohydrate, 7.75 g
of fiber and 0.25 g of fat in one 8 oz serving with water. Optionally,
this composition may also include vitamins and other supplements
such as calcium.
The compositions of other preferred and suitable variations in
the snack composition are provided in Table 5. It is understood
that the compositions have a pH, or that their pH is adjusted to
be, about 6 or greater.
TABLE-US-00005 TABLE 5 COMPOSITIONS SUITABLE FOR PREPARATION OF
THE SNACK FOOD COMPONENT OF THE PRESENT INVENTION formula #2 formula
#3 formula #4 ingredient amounts (g) amounts (g) amounts (g) maltodextrin
35 38 33 dextrose 10.5 14 16 sucrose 2.0 -- -- Penplus UM Starch
3.0 3.5 2.8 H & R Orange 0.09 -- 0.09 WJ Yellow No. 6 0.03 0.03
0.01 Niacinamide 0.005 -- 0.005 pantothenate 0.0025 -- -- thiamine
-- 0.0005 0.0005 calcium phosphate 0.50 -- 0.50 magnesium phosphate
0.20 0.40 0.1
3. Large Scale Preparation
Large scale methods for preparation of the composition of the invention
will be apparent to one skilled in the art.
4. Weight Loss Methods
A non-acid weight loss program is disclosed, based on the compositions
of the invention, i.e., a non-acid mixture of dietary carbohydrates
which elevate brain serotonin levels, thereby enhancing satiety
and suppressing the desire to snack on carbohydrate- and fat-rich
foods, that utilizes multiple channels to promote weight loss in
overweight and obese men and women who may suffer from gastric hyperacidity,
acid reflux, or both. This program is generally useful to treat
individuals suffering from a carbohydrate craving universally complained
of by individuals on a diet, as well as for the treatment of overeating
in individuals suffering from stress, PMS, menopausal symptoms,
"winter blues", binge eating, smoking withdrawal, alcohol
withdrawal, mild pain/itch, sideffects of various psychotropic drugs,
and to promote sleep.
1. Use of composition to treat individuals suffering from gastric
distress
Major components of the non-acid weight loss program include the
composition of the invention having pH 6 taken twice each day as
a beverage; education about nutrition and portion control; physical
training with a qualified trainer; and individual and group counseling
sessions.
In a small study involving five patients treated for twelve weeks,
weight loss was comparable to that occurring with an acidic carbohydrate-based
weight-loss beverage (0.91 pounds per week for the non-acidic, and
0.83 pounds per week for the acidic beverage). The acidic beverage
group used acidic snack compositions according to U.S. Pat. No.
5,595,772. None of the patients complained of gastric distress when
taking the non-acidic formulations. (One of the five had been completely
unable to utilize the original, acidic drink, even if she also took
Prilosec, an anti-ulcer drug. Two of the others stated that they
had experienced gastric distress with the acidic drink, and had
"treated" it by eating more foods, a counterproductive
activity.)
The mechanism by which the compositions of the invention enhance
satiety and suppress the tendency of very many overweight people
to snack heavily on carbohydrate-rich and fat-rich foods involves
the ability of those carbohydrates to produce a significant and
reproducible increases in the rates at which brain neurons synthesize
and release the neurotransmitter serotonin. This effect starts within
minutes of the time the subject drinks the beverage composition
of the invention and lasts for 3 or more hours. The particular carbohydrates
in the composition cause insulin to be secreted; this hormone, in
turn, changes the levels of amino acids in the blood stream causing
one of them--tryptophan--to be taken up to the brain, where it is
converted to serotonin. This arise in serotonin also occurs when
people eat normal meals, and is one of the most important mechanisms
that causes people to stop being hungry. It can also improve the
mood, making people feel less depressed and anxious.
However, normal meals, unlike the composition of the invention
may also contain large amounts of fat, which tends to increase body
weight, or of proteins, which block the rise in brain serotonin.
Thus it is necessary to use a fat-free and protein-free preparation.
A frequent cause of obesity is "carbohydrate carving"--the
tendency of people to use dietary carbohydrates as though they were
a drug, because the carbohydrates relieve their feelings of depression
and anxiety by increasing brain serotonin.
Thus, the composition of the invention exhibits many advantages
over other weight-loss products, including, but not limited to the
following: It is a natural, food-based product. It can be taken
regardless of what medications the subject might also be taking.
(It should not, however, be used by people with diabetes.) It is
not associated with tolerance or addiction potential, and people
do generally not exhibit rebound eating after it is withdrawn. Its
satiety-promoting effect helps users to control the size of the
food portions they actually choose to eat, --thus facilitating adherence
to low-calorie food plans. Its mode of presentation (9 oz of liquid)
makes it highly unlikely that it will be used for bingeing. It has
no known side-effects; there are no limitations on the duration
of the treatment; and it is safe for any age group.
2. Use of composition to treat individuals carving carbohydrates
In each example, except as indicated, the efficacy of the composition
is demonstrated by administering it or its placebo, i.e., a nutrient
mixture that also contains sufficient protein to block the carbohydrate-induced
rise in brain serotonin levels. The experiments use a crossover
design in which each subject serves as his/her own control, receiving,
at random, the active or the placebo composition twice daily (before
lunch or dinner) for two weeks. Various standardized indices of
mood (Hamilton Depression Test, POMS Test, VAMS Test, Stanford Sleepiness
Scale) are administered after one or two weeks of treatment, at
intervals, e.g., 1, 2 and 4 hours, after consumption of the test
preparation. Subjects are also weighted initially and at one or
two weeks after each treatment (active or placebo), and are also
interviewed briefly and asked about their eating behavior, e.g.,
carbohydrate-craving and fat-craving. STRESS Subjects who claim
that they experience stress on a daily basis are evaluated for 4
weeks using a self-report that keeps track of the individual's usual
sources of stress (self reported personal stress inventory). Subjects
rate the frequency of the stressful events occur daily and on a
scale of 1 5, evaluate the intensity of the stress. Subjects fill
out the CES-D which is a self reported scale of anxiety and depression.
This is done daily as well. Subjects who indicate a consistent level
of stressful events daily determined by at least 2 events occurring
per day and who rate in the mild to moderate anxiety level on the
CES-D participate in a test of the carbohydrate intervention on
daily stress. Subjects are given either the composition of the present
invention formulated as a drink or its placebo (a drink that did
not elevate serotonin levels) for two weeks and then switch to the
alternate drink for another two weeks in their cross over design.
The drinks are consumed an hour before lunch and between 4 and 6
PM. Subjects are asked to fill out the self reported personal stress
inventory on a daily basis and also take the CES-D on a daily basis.
The stress scores and CES-D scores are compared for each subject
while on the carbohydrate drink and on the placebo. Subjects on
psychotropic drugs or other drugs that might alter behavior are
excluded from the study as are smokers and recreational drinkers.
MENOPAUSAL SYMPTOMS A special formulation is made that includes
both the composition described in the present invention and other
ingredients designed to ameliorate other, related symptoms, e.g.,
pain, mild cognitive disturbances. The placebo is a protein-rich
formulation of similar taste and lacking the other active ingredients.
Subjects receive the active or the placebo preparation for four
randomized periods of one month each. The assessment of their responses
is by interview and using the tests described above. WINTER BLUES
Subjects exhibiting the characteristic loss of energy, hypersomnia,
sadness, and tendency to weight gain, starting in November each
year, receive the composition or the placebo for four randomized
one-month periods, and tested as above. BINGE EATING This example
evaluates the effect on the carbohydrate drink on individuals both
obese and of normal weight who eat at least 50% more than they normally
eat in a very short period of time at least twice a week. This is
not a study of binge eating disorder, but more a common problem
of intermittent overeating. A screening period of two weeks takes
place in which individuals claiming a tendency to binge frequently
keep track of their food intake. Subjects who report an excessive
food intake compared to their own normal food intake enter the study.
Subjects who suffer from eating disorders or are on medications
that might alter eating behavior are excluded from the study. The
subjects are their own controls and participate in a cross over
study in which they are randomly assigned to receive the carbohydrate
drink or its placebo during that time of day when they are most
likely to binge. They are told to consume the drink an hour before
their normal binge time on an empty study and keep track of their
binges and their food intake during the binges during the two week
testing periods. SMOKING WITHDRAWAL Coincident with smoking withdrawal,
subjects start to consume the composition twice daily, just prior
to the daily predetermined periods when they anticipate the greater
difficulty in continuing not to smoke. Subjects are pair-matched,
based on degree of obesity and on whether or not they are also taking
nicotine or another drug for smoking withdrawal, the other member
of the pair is given the placebo preparation. Treatment is continued
for two-months. Patients are weighed and interviewed every two weeks.
ALCOHOL WITHDRAWAL Subjects are selected based on their desire to
suppress weight gain, carbohydrate-craving and mood changes that
often occur in otherwise normal individuals who are trying to decrease
their weekly consumption of alcoholic beverages, but do not perceive
themselves as requiring the rigor of a formal program like AA. Pair-matched
subjects receive either the active or the placebo preparation for
two-months, and tested as above. SLEEP ONSET Normal volunteers and
people who allege that they often have difficulty falling asleep,
will be tested, after receiving the active or placebo preparation,
at home, using wrist actigraphy. The data stored in the actigraph
is analyzed to determine whether consumption of the active or the
placebo preparation thirty minutes before bedtime decreases the
amount of time before the subjects fall asleep (as demonstrated
by a near-cessation of motor activity).
Accordingly, it should be apparent to one of ordinary skill in
the art that other embodiments of the present invention can be made
without departing significantly from the scope and spirit of the
disclosed invention, which invention should not be construed as
being limited to any of the specific examples provided, and which
invention is limited only by the claims that follow. |