Weight loss abstract
The invention is based on the discovery that substances which release
ZAG proteins from lymphocytes also cause accelerated weight loss
in humans. By administering an amount of the substance which is
effective to cause the weight loss but is beneath an amount which
causes side effects, a very desirable "dieter's aid" is
provided. A dilute mixture of alfa interferon and gamma interferon
in an aqueous medium is highly suitable for this purpose. It is
administered at a much lower dosage than is generally employed for
antibiotic purposes, thereby avoiding generally universal side effects.
For periods of time extending at least for a few days, the weight
loss composition of the invention causes weight loss at a greater
weight than would be expected from fasting, at least for seriously
overweight individuals.
Weight loss claims
What is claimed is:
1. A method for promoting weight loss in a human in need thereof,
said method comprising
administering to said human an effective amount, which, of a mixture
of alpha interferon and gamma interferon to cause the production
and release of zinc-.alpha..sub.2 -glycoproteins from lymphocytes
in said human, thereby stimulating lipid breakdown and a reduction
of fat stores in said human, such zinc-.alpha.2-glycoproteins having
a tendency to precipitate with zinc salts and exhibiting electrophoretic
mobility in the region of alpha-2 globulins.
2. A method for promoting weight loss in a human in need thereof,
said method comprising
administering to said human an effective amount, of a mixture of
alpha interferon and gamma interferon to cause the production and
release of zinc-.alpha..sub.2 -glycoproteins from lymphocytes in
said human, thereby stimulating lipid breakdown and a reduction
of fat stores in said human, such zinc-.alpha..sub.2 -glycoproteins
having a tendency to precipitate with zinc salts and exhibiting
electrophoretic mobility in the region of alpha-2 globulins,
wherein a daily dosage in the range of 50 to 5,000 units of alpha
interferon and 50 to 5,000 units of gamma interferon is administered.
3. A method as in claim 2 wherein the daily dosage is nasally or
buccally administered over a plurality of applications.
4. A method as in claim 2 wherein the daily dosage is administered
sublingually as a spray, tablet, capsule or lozenge.
5. A method as in claim 2 wherein the daily dosage is administered
sublingually as a spray having a volume of about 0.1 ml and containing
about 150 units of alpha interferon and 150 units of gamma interferon
applied three times daily.
6. A method as in claim 5 wherein the daily dosage is administered
for a first period of time in the range of 3 days to about 30 days
and then is withheld for a second period of time.
7. A method as in claim 6 wherein the second period of time is
in the range of from about 3 days to about 30 days, and wherein
said method further comprises continuing the administration of the
daily dosage for a third period of time in the range of 3 days to
about 30 days after the passage of the second period.
8. A method as in claim 2 further comprising alternately administering
the daily dosage for a first period of time and withholding the
daily dosage for a second period of time until a predetermined amount
of weight loss has occurred.
9. A method for causing weight loss in a human comprising administering
to said human on a daily basis for a period of time in the range
of 3 days to 30 days an effective amount of a weight-loss composition
comprising both alpha interferon and gamma interferon to cause weight
loss at a greater rate than fasting.
10. A method for causing weight loss in a human in need thereof
comprising
administering to said human on a daily basis for a period of time
in the range of 3 days to 30 days an effective amount of a weight-loss
composition comprising both alpha interferon and gamma interferon
to cause weight loss at a greater rate than fasting
wherein a daily dosage in the range of 50 to 5,000 units of alpha
interferon and 50 to 5,000 units of gamma interferon is administered,
said process further comprising
predetermining a desired amount of weight loss, and
discontinuing the weight-loss composition when the desired amount
of weight loss has been reached.
11. A method for a human to self-induce weight loss comprising
self-administering an effective amount of a weight-loss composition
comprising both alpha interferon and gamma interferon to cause weight
loss at a greater rate than fasting for a period of time in the
range of 3 days to 30 days.
12. A method for a human to self-induce weight loss comprising
self-administering an effective amount of a weight-loss composition
comprising both alpha interferon and gamma interferon to cause weight
loss at a greater rate than fasting to 30 days,
wherein a daily dosage of the weight-loss composition is nasally
or buccally, administered over a plurality of applications and the
daily dosage is in the range of 50 to 5,000 units of alpha interferon
and 50 to 5,000 units of gamma interferon.
13. A method as in claim 12 wherein the daily dosage is administered
sublingually as a spray having a volume of about 0.1 ml and containing
about 150 units of alpha interferon and 150 units of gamma interferon
applied three times daily.
Weight loss description
BACKGROUND OF THE INVENTION
Body weight and obesity are like the weather: Everyone talks about
it, but no one seems able to do much about it. In recent years researchers
have learned a great deal about the cause and ramifications of obesity.
Metabolism-the way we absorb, utilize, break down and eliminate
the waste from food stuffs-is only a part of the difference between
individuals. In order to understand these differences, the playing
field must be analyzed, not a macro-cellular level, but rather at
a micro-cellular level.
At the micro-cellular level, uncoupling proteins (UCPs) have been
found to exist and they dissociate the reactions that break down
food from those that produce the body's chemical energy. These UCPs
let hydrogen ions pass through the cellular inner mitochondrial
membrane, thereby abolishing the hydrogen ion gradient needed to
drive ATP synthesis. If the UCPs activity could be increased by
1-2% then there would be an increase fat oxidation and thermogenesis.
This would translate into a boost in resting metabolic rates and
subsequent weight loss for millions of individuals. A technique
to increase the action of the body's own uncoupling proteins would
be very desirable, and could add years of life for certain individuals.
SUMMARY OF THE INVENTION
In one embodiment of the invention, there is provided a method
for promoting weight loss in humans. The method is carried out by
administering effective amount of a substance which actuates the
production and release of ZAG proteins from lymphocytes, but preferably
beneath an amount which causes side effects.
In another embodiment of the invention, there is provided a composition
of matter highly suitable for use in the above method. The composition
comprises a dilute mixture of alfa interferon and gamma interferon
in an aqueous medium. The concentration and daily dosage of the
interferons is generally well beneath concentrations and dosages
employed for antibiotic purposes.
In still another embodiment of the invention, there is provided
a method for causing weight loss in humans which is more effective
than fasting. The method is carried out by administering an effective
amount of a weight-loss composition comprising both alfa interferon
and gamma interferon on a daily basis for a period of time in the
range of 3 days to 30 days. At least during the initial part of
the period, weight loss for many individuals occurs at a greater
rate than would be caused by fasting.
In still another embodiment of the invention, there is provided
a method for a human to self-induce weight loss. The method is carried
out by self-administering an effective amount of a weight-loss composition
in a manner and amount as described above.
DETAILED DESCRIPTION OF THE INVENTION
We have found that a substance which triggers the production and
release of ZAG proteins from lymphocytes will cause weight loss
when administered to humans. The amount of the substance employed
should be beneath any amount which causes side effects.
The substance is preferably administered as a weight-loss composition
which comprises a mixture of alfa interferon and gamma interferon.
On a daily basis, the amount employed is much lower than an amount
which would constitute an effective anti-biotic.
Surprising, the weight-loss composition causes a loss of weight
at a rate faster than fasting for many people, at least during the
initial part of the treatment period. In other words, many people
exhibit weight loss at a rate of greater than 0.5 pounds per day.
The rate of weight loss is achieved without dieting. In other words,
program participants may ingest normal amounts of food, for example,
in the range of 1,500 to 2,500 calories per day.
A daily dose of the weight-loss composition of the invention can
be effectively self-administered, and is preferably nasally or buccally
self-administered over a plurality of applications. More preferably,
the daily dosage is administered sublingually as a spray, tablet,
capsule or lozenge. Administering the daily dosage sublingually
as a spray has been tested with good results and is therefore most
preferred.
A daily dosage in the range of 50 to 5,000 units of alfa interferon
and 50 to 5,000 units of gamma interferon is believed generally
suitable in accordance with the invention, and should not be so
high as to produce side effects. In contrast, an amount of interferon
which is effective as an antibiotic is generally at least 1,000,000
units daily, and almost always produces undesirable side effects.
For spray application, the weight loss composition most preferably
comprises a dilute mixture of alfa interferon and gamma interferon
in an aqueous medium. Phosphate buffer solution is a highly suitable
aqueous medium. A concentration of alfa interferon at a concentration
in the range of 150,000-15,000,000 IU/liter and gamma interferon
at a concentration in the range of 150,000-15,000,000 IU/liter is
believed generally suitable. A concentration of alfa interferon
in the range of 500,000-5,000,000 lU/liter and gamma interferon
at a concentration in the range of 500,000-5,000,000 IU/liter is
preferred.
The weight loss composition of the invention can be conveniently
supplied and distributed in containers containing a few milliliters
of the inventive composition in liquid form. Preferably, the containers
constitute spray bottles which are configured for administering
a metered dose of about 0.1 ml per spray. Such a bottle will apply
about 150 units of alfa interferon and about 150 units of gamma
interferon per dose when it contains alfa and gamma interferon at
a concentration of about 1,500,00 IU/liter each. This dosage, applied
three times per day, has been tested with good results.
During testing, it was noted that the rate of weight loss was generally
higher during the initial part of the test period than during the
latter part. It is thus believe that the weight-loss composition
will be most effective when administered for relatively short periods
of time. Generally speaking, it is thought that the daily dosage
of the weight loss composition should be divided and administered
as a plurality of doses for a treatment period which is in the range
of from about 3 days to about 30 days and then discontinued for
a similar period of time. If additional weight loss is desirable,
then administration of the weight-loss composition can be recommenced.
The weight loss composition can be alternately administered or withheld
for similar periods of time until a predetermined amount of weight
loss has occurred.
EXEMPLARY EMBODIMENT
Obesity and severe weight loss are not polar ends of a linear process.
They both are, in fact, the end result of a complex series of interactions
that culminate in a net change in body weight. Most of the current
strategies for treatment of obesity target the obesity signaling
pathway by inhibiting serotonergic neurons, inhibiting noradrenergic
neurons, interfering with obesity receptors, stimulating endocrine
function and/or acting on pancreatic lipases.
Cachexia (or severe weight loss), in stark contrast to obesity,
is a wasting syndrome caused by depletion of occasionally muscle
and always adipose tissue that is ultimately present in the majority
of patients with cancer, AIDS and other life threatening diseases.
A soluble glycoprotein present in the serum and other bodily fluids
appears responsible for the fat-depletion component of cachexia,
since it stimulates lipid breakdown in adipocytes and reduces fat
stores. Moreover, this protein is overexpressed in carcinomas that
induce fat loss but not in other tumors. This glycoprotein is called
the ZAG protein from its tendency to precipitate with zinc salts
and its electrophoretic mobility in the region of alfa-2 globulins.
It appears that ZAG normally functions to regulate lipid degradation,
which increases to a pathological extent in cachexia.
We have found a new natural formulation, which we have named ObeX,
that appeared to activate the production and release of ZAG proteins
from lymphocytes. This activates the lymphocyte's release of the
ZAG protein mechanism to result in adipocyte shrinkage and cell
loss and thus promotes weight loss.
The formulation used in the clinical trial described below was
made by dissolving 3 million units of alfa interferon and 3 million
units of gamma interferon in 2 liters of sterile phosphate buffer
solution. The phosphate buffer was as described in U.S. Pat. No.
5,773,241. The formulation was dispensed in 30 ml spray bottles
to our test subjects. The formulation, labeled ObeX, was sprayed
into the oral cavity, specifically 0.1 ml under the tongue, three
times a day, for ten days. Each dose delivered about 150 units of
alfa interferon and 150 of gamma interferon.
The following table illustrates the individual and mean responses
of this study group.
TABLE I ObeX Study Subject Wt. 0 Wt. 1 Wt. 2 Wt. 3 Wt. 4 Wt. 5
Wt. 6 Wt. 7 1 183 181 181 182 180 180 180 179 2 155 154 3 300 296
4 143 136 5 338 330 327 321 319 6 245 238 240 238 238 7 143 135
8 230 227 223 223 223 223 222 222 9 242 239 237 235 235 10 226 223
11 176 173 12 298 280 13 128 128 14 236 217 210 15 222 220 16 205
200 17 197 182 Total 3667 3530 Mean Wt 215.7 207.4
Discussion
The test subjects were 17 normal obese adults with whose initial
weight ranged from 128 to 338 pounds with a mean of 215.7 pounds.
Each subject was instructed not to diet and to live a normal life
and in addition to use ObeX spray three times per day and report
weight/girth frequently. One-two weeks later the weight ranged from
128 to 319 pounds, with a mean of 207.4 pounds. There were no reported
side effects and the overall mean weight loss for this group of
subjects was 8.3 pounds. Moreover, from 1-5 inches was lost in the
girth as measured at the waist for this group of subjects. It appears
that from the data that the more morbidly obese patients lost more
weight from ObeX than subjects that were only mildly obese, and
that most of the weight loss was in the initial portion of the study.
Amazingly, the rate of weight loss over the course of the study
was 0.83 pounds per day, whereas total fasting (zero caloric intake)
would be expected to result in a rate of weight loss of only 0.5
pounds per day in persons of normal metabolisms.
While certain preferred embodiments of the invention have been
described herein, the invention is not to be construed as being
so limited, except to the extent that such limitations are found
in the claims. |