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ORDER GARCINIA CAMBROGIA

CASE STUDY:

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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