A Non-Prescription Alternative in Weight Reduction Therapy by
Anthony A. Come, M.D.
Editor’s Note: This issue’s submission for How I Do It In My
Bariatric Practice was written by one of ASBP’s early bariatric
pioneers, Anthony M. Conte, M.D., of Hilton Head Island, South
Carolina. Dr. Conte graduated from the University of Pittsburgh
and the University of Buffalo School of Medicine.
Introduction
I have been in the private practice of bariatric medicine and
related diseases since 1963. In that time, I have utilized all of
the medical protocols available to bariatricians.
As a clinical investigator, I have conducted about 20 clinical
studies on appetite suppressants and meal replacement products for
several leading pharmaceutical companies and manufacturers.
Some of these studies and their results, used in compliance with
FDA regulations, have been published in medical literature. I
would like to share with the readers of The Bariactrician, in the
How Do I Do It In My Bariatric Practice section of our Jjournal,
my experiences in the use of a new product with which have had
success. The product in this study, which I have been using in my
bariatric practice, was utilized to test the efficacy, safety, and
compliance of the product on about 50 volunteer obese patients.
Herbal Fat Burner, a non-prescription alternative, is a
capsule whose ingredients are 500 mg rind of Garcinia Idica and
100 mcg chromium (Ni Chromium III GTF). The active ingredient
extracted from the Garcinia Cam-bogia (Indica), better known as
brindall berry, is (-)-hydroxyc-itrate. Its properties, according
to available published scientific investigations, are such that it
acts as an appetite suppressant and a lipid lowering agent. This
alone could make it of value in the control of obesity and certain
lipid disorders.
The mode of action of (-)-hydroxycitrate, i.e. the brindall berry
extract (BBE), appears to center on its ability to slow the
regeneration of acetyl CoA—the citrate cleavage enzyme outside
the mitochondria in hepatic cells. The effect is to reduce the
major source of carbon atoms available for the synthesis of
triglycerides, cholesterol and storage of fat without reduction in
energy output. Carbon atoms are instead directed to glycogen in
the muscles and liver, resulting in more stamina and increased
endurance, but not increased body weight. The properties of
chromium (GTF) have been known for about 15 years, and I have used
it extensively in my bariatric practice. It is a key natural
mineral that “keeps insulin level in check by making the hormone
more efficient at regulating blood sugar levels,” says the U.S.
Dept. of Agriculture.
Chromium (GTF):
- · Controls appetites.
- · Reduces cravings for sweets.
- · Increases metalxAic rates.
- · Helps the body to bum up fat “preferentially.”
- · Helps the body to “preserve” lean body mass.
- · Increases levels of energy.
- · Reduces triglycerides, cholesterol levels.
- · Stabilizes blood sugar levels.
- · Produces weight loss without undue severe dietary
restric-tions.
It appeared to me that the combination of the brindall berry
extract [(-)-hydroxycitratel and the chromiurn (Ni chromium
III GTF)] was ideal because of their “synergistic”
actions. But more important, here was an opportunity for me to
test a non-prescription alternative in weight reduction
therapy.
The Protocol — A Double Blind Study
Duration: Eight weeks
Inclusions:
Males and females.
- 1 to 55 years of age.
- Degree of obesity: 15%-45% overweight
- Reasonably “good” health.
- Compliance with requirements of study.
- Commitment to eight weekly visits
Exclusions:
Any weight in the preceeding 30 to 60 days.
- Concomitant medications except for:
- a. Birth control
- b. Occasional aspirin, etc.
- No routine daily medications for diagnosed medical
conditions.
Forms:
- 1) Informed Consent
- 2) Initial Data
- 3) Initial Week Report (Lab. Data — Physical Examination)
- 4) Weekly Subject Questionnaire -
- 5) Weekly Visit Report
- 6) Summary Sheet
All forms were in triplicate. Two forms were returned to the
manufacturer and one was kept in my office file.
{Editor's Note: In the interest of brevity we have excluded
certain information that would only be of interest to medical
professionals. If you wish, we will fax you a full copy of Dr.
Conte's study.}
Obectives
- 1) Weight loss: Adequate not drastic.
- 2) Safety: No severe complications or side reactions.
- 3) Appetite suppression: Decreased cravings for sweets.
- 4) Reduction in blood lipids levels.
- 5) Feeling good: High energy level — no nervousness.
- 6) Looking fit and trim.
-
7) Compliance: Convenient, simple
instructions.
Participants
54 volunteers qualified and started the
study.
-
30 were given Product-A and 24
received Product-B. All subjects were given the same
dietary instructions and were told to continue their
usual physical activity. No effort was made to enforce a
more strenuous or more frequent exer-cise program.
The dietary instructions were reviewed with the subjects
in an identical manner; emphasis was placed on the
values of the Smart Choices Diet: low-fat, low-sugar,
low-sodium, high fiber, variety, moderation, and
balance. All were encouraged to drink 64 oz. of water a
day for its beneficial effects. The protocol was
reviewed with each volunteer and a final commitment was
made by each one to abide by the require-ments of the
study.
Forty persons completed the study; 23 in Group A and 17
in Group B, the placebo (control group). The results of
this study are indicated in Figure 1 and the conclusions
in Figure 2.
RESULTS
The total weight loss by the 29 subjects taking HCA and
Chromium, and who completed the 8 week study was 288
pounds.
The control group which took a placebo (sugar pill) was
a loss of 64 lbs. Of the people who gained weight there
was only 1 in group taking Herbal fat Burner and that
was a total of a 1/4 pound. However, 7 subjects taking
the placebo gained a total of 7.25 lbs during the study
period.
The average weight loss was 11.5 pounds for the people
taking herbal fat burner and 4.2 pounds for those taking
a placebo. [Editor's Note: remember that all were under
the care of a physician during this time]
Volunteers taking Product A [Herbal Fat Burner with
HCA and Chromium]lost over 2-1/2 times as much weight as
the volunteers who were on a placebo
Group A volunteers complied with the instructions better and were more
enthusiastic about the weight loss than Group B.
- The level of appetite suppression was greater in Group A than in Group
B.
- The level of energy was greater in Group A than in B
- There were no reactions such as sensitivity to cold, dry skin,
nervousness, dizziness, hypertension or hypotension, fatigue,
constipation, diarrhea, muscle cramps, halitosis or change in menstrual
pattern.
- There was only one questionable case in which one volun-teer with
multiple allergies complained of some itching around the mouth after being
on the study for one or two days. It went away when she stopped taking the
capsules and recurred when she was taking them three times a day but not
when she was taking them two times a day. By mutual consent, she dropped
out of the study.
- Another 13 dropped out at various stages of the study due to an
inability to return for the weekly visits. Some went on vacation, some
were on jury duty, others had transportation problems. Some, especially
those in Group B, became discour-aged when they didn’t lose the expected
weight.
- Cravings for sweets were markedly reduced in Group A.
- Spontaneous remarks, predominantly in Group A, were about the easy,
convenient way of taking only one capsule three times a day; having
nothing to mix or stir; being allowed the variety of ordinary grocery
foods; the smart substitutions of low-fat, low-sugar foods; not having to
count calories; having adequate amount of food; eating the same food as
other mem-bers of the family — eating the smart, healthy way. Above all,
My own clinical impressions
The product will most likely be marketed to bariatricians as an
alternative and attractive non-prescription modality avail-able to augment
the bariatric physician’s armamentarium in fighting the “battle of the
bulge’” Here are some additional thoughts- and rationale: 1) It fits
with the new age of alternative medicine, which is rapidly catching on
because the public is fed-up with surgery, drugs, and quick fixes. 2) It
fits in my bariatric practice in che state of South Carolina because it
tends to decrease total reliance on con-trolled prescription drugs. 3) The
results compare very favorably with those achieved by my patients who are
on appetite suppressants, diuretics, thy-roid, injections, and nutritional
supplements. The loss of weight is more gradual and not as drastic as with
the Very-Low Calorie diets, but being slower leads to a more permanent
weight loss than can be achieved through dieting, protein drinks or other
meal replacement products. Adding a regular, enjoyable, realistic aerobic
exercise to the easy to follow Smart Choices Diet will definite! increase
the weight loss, significantly reduce the percentage of body fat, and
increase the percentage of lean body mass. This product is economical;
convenient to dispense in bot-tIes of 84 capsules—a four-week supply;
requires no special stor-age; it is not a drug; and its ingredients are
not on the FDA list of 100 or so products used for weight cor’trol which
was published in August of 1991.
Long-term health benefits It reduces blood lipids, stabilizes blood sugar
levels, and it can be very useful in my maintenance program and in the
pre- vention of additional weight gain. Previous studies claim thac no
eating rebound was observed when administration of the product was
discontinued. I am convinced that this product, which combines smart
eating with a non-drug, all-natural weight loss enhancer and some basic
lifestyle strategies, will be an effective, safe, afford-able,
high-compliance program because it satisfies the five cri-teria of an
effective medical weight loss program: 1) It provides an effective means
of caloric restriction. 2) The Smart Choices Diet enables the patients to
make wise, varied and palatable food choices. 3) It incorporates an
individualized, realistic exercise pro-gram. 4) The lifestyle strategies
and the product allow the patients to control their food consumption. 5)
It provides a mechanism for continuing support, i.e. a high degree of
compliance. (Crash is out — moderation is in.) Reports of health
problems after quick and drastic weight loss have affected the
very-low-calorie liquid diet market. The desire to lose weight is strong,
but even stronger is the desire to lose weight permanently with a
self-designed diet that includes favorite foods and a calm, collected
approach rather than a frenetic, lose it now mentality. As I consistently
remind my patients: — Good health is your most precious possession and
is an ongoing process. — Keep on target with the designs for healthy
living. — Eat right — eat light — exercise. K
**Statements contained herein
have not been evaluated by the Food and Drug Administration. These
products are not intended to diagnose, treat and cure or prevent
disease. Always consult with your professional health care provider
before changing any medication.**
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