Thermogenesis - what is it?
Thermogenesis is the creation of heat within the living body. The amazing human body not only monitors its own temperature, it also directs the changes needed to keep the temperature constant. Steady temperature is most essential in the trunk of the body where the vital organs are located. The circulating blood carries much of the heat in the body. The body can direct rapid changes in blood flow to either dissipate or conserve heat. By opening blood vessels in the arms and legs, excess heat can escape from the body, thereby preventing injury from overheating. Yet in cold weather it can conserve precious heat by closing down blood flow to the hands/feet, preserving warmth in the main part of the body. Where cold climates are sustained, the body can actually turn on internal “heaters” that burn off excess fat to generate heat. This is Thermogenesis in the purest sense in that the body actually makes it’s own heat rather than simply conserving what it has

These "internal heaters" were only conclusively identified in 1979 as Brown Adipose Tissue (BAT)[1] . BAT seems to have the sole purpose of burning fat that is stored in adjacent white adipose tissue. This utilization of stored fat to create heat is performed by an intrinsic BAT protein that is not typically found anywhere else in the body. This protein is called Uncoupling Protein (UCP) since it uncouples energy production from any other cellular function[2] . This energy derived from fatty acid oxidation is merely dissipated as heat. UCP, present in brown but not white fat, is the ultimate fat burner.

Thermogenesis occurs even in primitive organisms such as bacteria. Even potatoes increase their expression of a UCP-like protein during cold exposure. However, in modern man, BAT functions not only to regulate body temperature but also to regulate energy balance. In cases of dietary gluttony, the same mechanism (UCP) is induced to discard excess calories to maintain homeostasis. Obviously, this innate method of reducing excess fat storage has become a topic of intense interest in recent years because of its broad application in human obesity. Because of the recent discovery, most physicians are relatively unaware of BAT, UCP, thermogenesis, and their relation to obesity. Most health practitioners have little experience with thermogenic formulas. Like me, most MDs have had very little exposure to thermogenic principles, even in prestigious Internal Medicine training programs.

Thermogenic defects are common genetic defects resulting in obesity.
The classic gluttony experiments performed back in the 1960s gave new insight into thermogenesis in overeating man[3]. In our modern society, gluttony is now the norm. However, there appears to be a widely disparate response between overeating and gaining weight. Individuals with intact thermogenic function are able to avoid excess weight gain even while constantly exceeding their daily caloric requirements. Those individuals who are unable to induce thermogenic mechanisms however, gain significantly more weight than counterparts when exposed to the abundance of enticing high caloric foods found everywhere today. Unfortunately, low fat diets that remove fat (the primary substrate for BAT) cause BAT to downregulate its activity and ultimately to atrophy. Well-intentioned recommendations from health professionals therefore have the undesired effect of actually crippling an important adaptive mechanism. Those individuals already genetically programmed toward obesity have the most unfavorable outcomes. Thermogenic formulas clearly show greater benefit for those attempting low calorie weight reduction[4]. For years, no one understood thermogenic mechanisms and therefore the repeated failure of low-fat diets remained a mystery.

There are several lines of evidence suggesting that BAT/thermogenic defects are major elements of sustained obesity. The first studies were performed almost 100 years ago by Rubner who showed increased heat production after dietary protein intake[5].

Ephedra/caffeine is the best thermogenic treatment available.

Synopsis with references
1. Longest track record of use in weight control - almost 30 years![6]
2. Superior to dexfenfluramine for weight loss.[7]
3. Superior to appetite suppressants (diethylproprion) for weight loss.[8]
4. Unique differential development of tolerance - Long term use upregulates thermogenesis, downregulates side-effects.[9]
5. Less adverse effects in obese versus lean individuals.[10]
6. Substantially induces the growth and activity of BAT.[11]
7. Selective agonist of Beta-3 adrenergic receptors only found in BAT.[12]
8. More effective and safer than any synthetically developed agent.[13]
9. Combination is 4 - 6 times more effective than either agent alone.[14]
10. No thermogenic treatment has ever been found to have equal efficacy.

Both Ephedra AND caffeine are required for optimal effect.
Ephedra (or the synthetic form, ephedrine) was originally thought to act only by appetite suppression. Only later was its distinct thermogenic action recognized. The original observation of weight loss with ephedra was noted in combination with caffeine (used to treat asthma). A large controlled trial of ephedrine alone showed only insignificant weight reduction[15]. This failure was largely ascribed to the lack of the synergistic effect of caffeine used in other studies[16]. Caffeine alone may increase the growth of BAT but appears to have no direct effect on thermogenic activity[17]. The combination of the two agents has marked supra-additive synergy, achieving results of 4 to 6 times the effect of either agent alone[18].

The principle of therapeutic index should be followed.
Obesity is (after smoking) the second most common cause of preventable death in our society. Over 300,000 deaths per year are ascribed to complications of obesity. Additionally, the tremendous burden of chronic illness, low self-esteem, and related misery suffered by the 50 million obese Americans requires a long-term solution. Diets have failed in this regard[19] and prescription treatments have proven ineffective, costly or even dangerous. The status of the ephedra/caffeine combination with its 28 year track record of safety and efficacy still stands as the first and foremost adjunctive aid to long-term weight management through thermogenesis.

[1.] Rothwell,NJ Stock,MJ A role for brown adipose tissue in diet induced thermogenesis Nature 281:31 1979
[2.] Lean,MEJ James,WPT Uncoupling protein in human BAT mitochondria FEBS Letter 163:235 1983
[3.] Miller,DS Mumford,P Stock,MJ Gluttony: Thermogenesis in Overeating Man Am J. Clin Nut 20:1223
[4.] Pasquali,R et al Does ephedrine produce weight loss in low energy adapted women? Int.J.Obesity 11:163
[5.] Rubner, M. Die Gesetze des Temeratur bei der Ernahrung Leipzig 1902
[6.] Malchow-Moller,A: Ephedrine as an anorectic: the story of the"Elsinore Pill" Int.J.Obesity 5:183
[7.] Breum, L et al Comparison of an ephedrine/caffeine combination and dexfenfluramine in the treatment of Obesity A double-blind multi-centre trial. Int.J.Obesity 18:99 1994
[8.] Malchow-Moller,A: Ibid Int.J.Obesity 5:183 1981
[9.] Astrup,A. et al Enhanced thermogenic responsiveness during chronic ephedrine treatment in man. Am. J. Clin. Nutr. 42:83
[10.] Pasquali,R. et al A controlled trial using Ephedrine in the treatment of obesity Int.J. Obesity 9:93 1985
[11.] Barnard,T. Biogenic amines and the trophic response of brown adipose tissue Biogenic Amines in Development Elsevier Holland pp.391-439
[12.] Stock,MJ Experimental studies with selective Beta-adrenergic agonists and antagonists in animals Int. J. Obesity 17:S69-72
[13.] Mowrey,DB Fat Management- The Thermogenic Factor Victory Publ. Lehi,UT 1994
[14.] Astrup,A Breum,L. Toubro,S. Int. J. Obesity 16:269 1987
[15.] Pasquali,R. et al A controlled trial using Ephedrine in the treatment of obesity Int.J. Obesity 9:93 1985
[16.] Miller,DS Letter to the editor Int.J. Obesity 10:159 1985
[17.] Buckowiecki,LJ Lupien,J. Follea,N. Am. J. Physiol. 244:R500-R507 1983
[18.] Astrup,A Breum,L. Toubro,S. Int. J. Obesity 16:269 1987
[19.] Bray,G: The Myth of Diet in the Management of Obesity Am.J.Clin.Nut. 23:1141 1970 .

Mechanism of Action and Therapeutic Use
Ephedrine is a moderately potent beta-adrenergic agonist. It possesses weak alpha-agonist activity, largely due to its effect on stimulating the release of endogenous catecholamines. Ephedrine owes its relatively long half-life (3-4 hours) to its resistance to degradation by the catalases COMT and MAO. After oral ingestion, it is very well absorbed with a rapid onset of effect. Although the molecule can undergo deamination and conjugation reactions in the liver, the majority is excreted unchanged in urine.

Today, ephedrine at doses of 25mg or less remains available in most states without prescription. It continues to be widely used by physicians in the treatment of various conditions ranging from urinary incontinence to orthostatic hypotension. The intravenous form is commonly employed during anesthesia.

Ephedra for Weight Management in Obesity
Weight loss with ephedra alkaloids was first observed in 1972 by a Danish physician in the small town of Elsinore, Denmark. That physician, Dr. Eriksen, noted significant weight reduction in many asthmatic patients for whom he had prescribed ephedrine and caffeine. He initially believed that this unintentional effect resulted from appetite suppression. Pursuing his observation, rumor spread throughout the country and the “Elsinore pill” was soon the rage as an anti-obesity treatment. Shortly the treatment became quite popular outside Denmark. It was estimated that 250,000 prescriptions were written for it annually in the United Kingdom alone.[6]

Randomized, controlled, double-blind clinical trials were conducted to further evaluate the “Elsinore pill”. These confirmed the efficacy and safety of the blend. It was shown that neither ephedrine alone[7] nor caffeine[8] produced weight loss but the combination proved quite potent. Relatively small doses of Ephedrine (20 mg) and Caffeine (50 mg) produced significant weight reduction compared to placebo[9]. The blend also compared favorably to other proven anorectic treatments6 and to newer anti-obesity treatments[10] Side-effects were minor and equivalent in frequency to other weight loss treatments. The blend was shown to be additive in benefit when added to cognitive and behavioral methods of weight management. Notably, side-effects essentially vanished within about a month with continued use6,10 This important observation would soon be explained by the discovery of a new physiologic mechanism.

Soon, it became apparent that sustained weight loss was much greater than could be accounted for only on the basis of appetite suppression. Investigations were begun to determine alternate mechanisms of action. A salutary effect on thermogenesis in Brown Adipose Tissue (BAT) was discovered to be greatly potentiated by the combination; amazingly 4 – 6 times greater than with either agent alone.[11]

Abuse of Ephedrine
In the 1990s, several unscrupulous marketing campaigns presented the Ephedrine/Caffeine combination to youth as an energy booster. This inappropriate activity by a few manufacturers brought about increased regulatory scrutiny because of the recreational uses and overdoses that followed. At about the same time, ephedrine also became mixed up with the illicit drug trade due to its use as a substrate in met-amphetamine manufacture. Therefore, despite centuries of safety when used appropriately, the sale of pharmaceutical grade ephedrine became regulated by many states. A large meta-analysis suggested that ephedrine was generally safe and that adverse effects occurred only in overdose.[12] Natural occurring Ephedra alkaloids once again came into widespread use for weight management. Most commercially available products, though immensely popular, are poorly balanced in the amount or proportion of the two essential elements: Ephedra and Caffeine. A new formulation, ThermoBean™ combines the time-tested formula possessing the ideal combination of these elements to achieve optimal safety and effect.

The ThermoBean™ formula is made available only in the context of a global program with other valuable elements focused solely upon weight management. This formula adds other ingredients shown to promote good health and long-term weight reduction. The innovative packaging and labeling of the compound virtually eliminates the possibility of abuse or misuse. Yet, the potential for appropriate use in weight management is fully developed. Both the ThermoBean™ program and formulation serve as a model for what can be accomplished utilizing recent federal mandates[13] to employ dietary supplements and vital education to promote optimal health.

Risk – Benefit Ratio
Obesity is (after smoking) the second most common cause of preventable death in our society. Over 300,000 deaths per year are ascribed to complications of obesity. Additionally, the tremendous burden of chronic illness, low self-esteem, and related misery suffered by the 50 million obese Americans requires a long-term solution. Diets have failed in this regard[14] and prescription treatments have proven ineffective, costly or even dangerous. The status of the old “Elsinore pill” with its 28 year track record of safety and efficacy still stands as the first and foremost adjunctive aid to long-term weight management

The ThermoBean™ Solution
The ThermoBean™ program promotes the regular consumption of legumes as a primary nutrition source. The utility and acceptance of legume protein is greatly enhanced by the program and the ThermoBean™ formula (see section entitled “Legumes as Health Food”). The thermogenic formula is the same one used in the majority of large scale clinical trials and continues to be tested in its current form with the addition of novel non-adrenergic thermogenic agents (see sections on “Thermogenesis” and also “Clinical Trials using ThermoBean™ “). Other ingredients added to the formula enhance vascular health or support immune function. Unlike other nonprescription weight control products, this program incorporates extensive tracking capabilities for users that should significantly aid in reporting of adverse events and beneficial results. In keeping with the goals of the DSHEA of 1997, the program incorporates innovative educational messages that improve consumers’ insight, knowledge, and motivation.

[1] Chen ,KK Schmidt,CF: Ephedrine and Related Substances Medicine 9:1-117 1930
[2] Ward,RM Mirkin,BL: The Treatmaent of Nasal Congestion Ann.Int.Med. 87:49 1975
[3] Chen,KK The action of Ephedrine, the active principle of the Chinese drug Ma Huang J.Pharmacol. & Exp. Therapeutics 24:339 1924
[4] Weinberger,MM Use of Ephedrine in Bronchodilator Therapy Pedi. Clin. N.Amer.22:121
[5] Porta,M Jick,H Habakangas,JS: Follow-up Study of Pseudoephedrine Users Ann Allergy 57:340
[6] Malchow-Moller,A: Ephedrine as an anorectic: the story of the”Elsinore Pill” Int.J.Obesity 5:183
[7] Pasquali,R. et al : A controlled trial using Ephedrine for Obesity Int.J.Obesity 9:93 1985
[8] Miller,DS Letter to the Editor Int.J.Obesity 10:159 1985
[9] Dulloo,AG Miller,DS: Potentiation of the Thermogenic effects of Ephedrine by Methylxanthines Proc. Nutr. Soc. 44:16A 1985
[10] Breum, L et al Comparison of an ephedrine/caffeine combination and dexfenfluramine in the treatment of Obesity A double-blind multi-centre trial. Int.J.Obesity 18:99 1994
[11] Dullo,AG Seydoux,J. Giradier,L. Peripheral mechanisms of thermogenesis induced by caffeine and ephedrine in brown adipose tissue. Int.J.Obesity 15:317 1990
[12]
[13]
[14] Bray,G: The Myth of Diet in the Management of Obesity Am.J.Clin.Nut. 23:1141 1970

Legumes in Antiquity
Legumes are a food family that contains peas, lentils, all varieties of beans, and even peanuts. Legumes have a storied history, from ancient times through to the present. Beans were venerated by the ancient Egyptians as tiny storehouses of energy. Ancient armies relied on beans due to their light weight, relatively imperishable nature, and excellent nutritive value. Even the biblical Esau traded his birthright for a bowl of lentil soup. Today, in cultures around the world, legumes continue to be the major protein source. (Note that none of these cultures has a problem with obesity).

Highest Protein Vegetable
This family is indeed, by far, the richest source of vegetable protein – even surpassing the protein content of some meats. Yet, this food contains virtually no fat and certainly no cholesterol. A major advantage of legumes over animal protein is the abundance of dietary fiber. Legume protein offers tremendous variety, blending well with other foods. Legumes are abundantly available and at a very low cost.

Lipid Therapy
Unlike meats, eggs, and dairy proteins that have high levels of cholesterol and saturated fat, legumes are generally low fat and virtually devoid of cholesterol. Yet legumes go beyond simply having a favorable protein to fat content. Many legumes actually lower plasma LDL levels while raising HDL. Soy protein has had the limelight in this regard.[i] However, other legume proteins work just as well, by inhibiting cholesterol absorption, interupting the enerohepatic circulation of cholesterol, and even by increasing hepatic cholesterol secretion into bile.[ii] Intact legumes appear to have greater effect on plasma lipid levels than the effect of legume fiber alone.[iii]

Excellent Fiber Source
One reason that legumes may outperform isolated soy protein is that the abundant fiber content of legumes is of additive value. Clearly, consumption of foods high in fiber has been associated with lower risk of cardiovascular disease. However, the impact of dietary fiber on other chronic diseases is only now being appreciated. The old classification of soluble and insoluble fiber is giving way to groupings that better describe the mechanisms by which fiber provides benefits. These properties include: · Viscosity – modifies rate and extent of absorption of various nutrients (see Diabetes below) · Fermentability – can produce products that alter metabolism · Sequestering ability – to effectively absorb or buffer sterols, bile acids, and simple carbohydrates.[iv] Legume fiber possesses all of these properties and is therefore probably the best balanced fiber occurring in nature.[v]

Diabetes Mellitus
Legume consumption can:
- Prevent or forestall the onset of adult-type Diabetes[vi]
- Improve diabetic control and reduce hypoglycemiax
- Reduce the risk of diabetic complications[v] Legumes contribute to weight loss, improved insulin sensitivity, and better lipid profiles.[v]

Renal Diseases
For many decades, it was believed that high protein intake accelerated the progression of renal disease. The Brenner hypothesis proposed that high protein intake by certain diabetic persons would result in renal damage by creating glomerular hypertension and hyperfiltration. Current evidence with soy protein however proposes a new hypothesis whereby the substitution of soy protein for animal protein is actually beneficial in slowing the progression of diabetic nephropathy. Studies in animal models[vii] and in diabetic humans[viii] demonstrate such a benefit for soy in reducing post-prandial hyperfiltration and in decreasing proteinuria.[ix] Similar findings are now positive for other legume diets as well.[x] These diets provide better overall nutrition than those that strictly limit protein and additionally provide benefits for lipids and diabetic control[xi]

Mineral Absorption
Legumes have been shown to reduce urinary Calcium secretion which may in turn prevent or retard osteoporsis[xii] A 100 g serving of legumes may contain over ¼ of the reccomended Calcium supplement for persons with osteoporosis. Additionally, such serving supplies abundant Iron, Zinc, Potassium, and Magnesium[xiii]

Limitations of Legume consumption
Despite the tremendous benefits associated with regular consumption of legumes, their use in the U.S. is negligible.[xiv] Part of the problem may simply be the image of the lowly bean as “poor man’s food”. The well-known effect on intestinal gas formation may add to the problem. Even some nutritionists adhere to the old belief that legumes are a “low biologic value” protein. These limitations are removed by the ThermoBean™ program.

The ThermoBean™ Solution
ThermoBean™ is a comprehensive program that unlocks the natural goodness of legumes for all to enjoy. First, the program offers creative, zesty menu ideas based around legumes. Participants gain insight into other cultures in which legumes are the primary protein source. Innovative legume snacks designed for weight loss are introduced. Secondly, participants are coached on preparation and serving techniques designed to reduce the gas forming tendency of some legumes. Lastly, the ThermoBean™ formula contains an active food-grade enzyme capable of pre-digesting the complex polysaccharides that would otherwise lead to gas formation. The formula also provides L-Methionine in an amount to fully balance the deficiency in some legume proteins. Vitamins to shunt away excess homocysteine are added to the formula as are anti-oxidants, Chromium picolinate, and Vitamin C to aid mineral absorption

[i] Anderson,JW Johnstone,BM Cook-Newell,ME Meta-analysis of the effects of soy protein intake on serum lipids NEJM 333:276 1995
[ii] Duane,WC Effects of legume consumption on serum cholesterol, biliary lipids, and sterol metabolism in humans J. Lipid Research 38:1120 1997
[iii] Brown,L. Rosner,B. Willett,WW Sachs,FM: Cholesterol-lowering effects of dietary fiber: a meta-analysis Am. J. Clin. Nut. 69:30 1999
[iv] Schneeman,BO: Building scientific consensus: the importance of dietary fiber Am.J.Clin.Nut. 69:1 1999
[v] Anderson,JW Smith,BM Washnock,CS Cardiovascular and Renal benefits of dry bean aand soybean intake. Am. J. Clin.Nut. 70(suppl):464S 1999
[vi] Salmeron,J. et al Dietary fiber, glycemic load, and risk of non-insulin –dependent Diabetes Mellitus in women JAMA 277:472 1997
[vii] Williams,AJ Walls,J. Metabolic consequences of differing protein diets in experimental renal failure Eur. J. Clin. Invest. 17:117 1987
[viii] Breyer,JA Diabetic nephropathy in insulin-dependent persons. Am.J.Kidney Dis. 20:533 1992
[ix] Anderson,JW et al Effects of soy protein on renal function and proteinuria in patients with type 2 diabetes Am.J. Clin. Nut. 68 (suppl.):1347S
[x] Barsotti,G. A low nitrogen Vegan diet for patients with Chronic Renal Failure Nephron 74: 390
[xi] Jibani,MM et al Predominantly vegetarian diet in patients with incipient clinical diabetic nephropathy: early effects on albumin excretion and nutritional status. Diabetes Med.8:949 1991
[xii] Barzel,US Dietary patterns and blood pressure NEJM 337:637 1997 [xiii] Geil,PB Anderson,JW Nutritional and Health implications of dry beans. J.Am.Coll.Nutr. 13:549 1994
[xiv] Smit,E. et al Estimates of animal and plant protein intake in US adults: Results from the Third National NHANES, 1988-1991 J.Am. Diet Assoc. 99:813 1999

I. Thermogenic Formula (alone) - Sep. 1998
29 obese subjects voluntarily consented to take part in a dose escalation study utilizing ephedrine and theophylline to assess the safety and efficacy of the independent and combined use of these agents in weight reduction. Each subject had previously failed to maintain desired body weight by diet and/or exercise which were not altered during the trial. The patients were typically considered “high-risk” individuals to take a thermogenic formula.

METHODS: Each patient gave informed consent, underwent complete physical and laboratory exams, and graded exercise tests. Each then began taking ephedrine 6.25 mg 3 times daily with meals. After 1 week, unless limited by adverse effect, subjects were titrated to 12.5mg and after 3 weeks to 18.5 mg TID, AC. During Phase I, each subject was randomized to receive either placebo or theophyline concomitantly in escalating doses of 100 mg, 200 mg, and 300 mg daily on weeks 1, 2, and 3 respectively. Phase II was identical in design except for cross-over in theophyline/ placebo assignment. Subjects began week 1of Phase II continuing their highest tolerated dosage of ephedrine, then continued to titrate as tolerated to a maximal dose of 25 mg TID. Each subject had weekly measurement of vital signs, weight, and interview for adverse experiences. At the conclusion of Phase I and Phase II, a physical examination was performed. Questionnaires were also collected at these visits.

RESULTS: Despite extending through holiday festivals, the use of the formulas resulted in 12.5 lb. average weight loss with no prescribed alteration of diet or exercise. Only one subject was unsuccessful at titrating to the highest dose level due to side-effect. There were no significant changes in vital signs and no serious adverse effects.

CONCLUSION: In accordance with previously published studies, ephedrine, augmented by methylxanthine, provides benefit for weight loss independent of diet or exercise alterations. No safety concerns were observed in a group of high-risk patients, each treated with up to 25 mg Ephedrine TID combined with up to 300 mg of theophylline.

II. Legume Protein for Weight Loss – Jun. 1999
14 overweight volunteers followed a diet substituting legume protein for meat-based protein for 4-7 months. Each individual gave medical history and underwent physical exam and laboratory testing. Instructions were given for adherence to a low –glycemic diet. Weight was measured and counseling provided on a monthly basis. The majority of participants were men. RESULTS: Weight loss correlated positively with compliance. Each subject lost weight on follow-up although variation was quite high (4- 45 lb.)

Most subjects maintained at least 50% of the maximum weight loss from baseline until the study conclusion. The majority of subjects found the diet simple to follow and enjoyable. CONCLUSION: Legume protein is a convenient, well-tolerated vehicle for long-term weight reduction.

III. ThermoBean™ Liquid Formula – Nov. 1999
33 obese subjects who had previously been refractory to standard weight management techniques used a novel blend of natural substances as an additive to legumes in an evaluation of effects on weight loss. The study used 2 formulas in a cross-over design in 2 periods of 4 weeks each. The formulas were identical except that one formula contained thermogenic compounds (ephedrine 22 mg/ caffeine 80 mg and medium chain triglycerides) while the other formula contained none.

METHODS: Each subject was given 2 hours of didactic instruction in 4 principles designated to aid weight reduction. These principles included:
1. Building legume protein into meals and snacks; recipes and techniques to inhibit gas
2. Using low glycemic index foods to prevent “sugar toxicity” and cravings.
3. Avoiding foods that stimulate further intake, increasing foods tat produce satiety.
4. Adding thermogenic elements to stimulate fat oxidation (randomized cross-over). Group A was assigned from a random sample to receive the novel blend “A” which contained elements to enzymatically degrade complex polysaccharides thereby reducing intestinal gas formation. The blend also contained L-methionine in an amount necessary to replace the deficiency of this compound (and cysteine) in legume protein. Group B was assigned to initially receive the same blend but additionally incorporating natural Ephedra alkaloids, caffeine, and also medium chain triglycerides in oil (blend “B”). Subjects and examiners were blinded as to which blend contained active thermogenic elements. Subjects were examined at 2 week intervals and crossed over to the alternate blend at the end of 4 weeks.

RESULTS: The study was flawed by a manufacturing defect in the Blend B formula during the second phase of the study. Additionally, many subjects complained of taste of Blend B and drop-out rate was high. No patient experienced adverse changes in vital signs. There was no difference between the blends in any effect attributable to Ephedra/ caffeine content. One patient discontinued after 2 days due to gas, four patients discontinued due to taste, and an additional 6 patients were lost to follow-up. In the remaining group, there was an average weight loss of 16 lbs. with an insignificant trend favoring Blend B. The findings were complicated by fewer subjects completing the second phase after cross-over to the flawed Blend B.

CONCLUSIONS: The liquid formula appeared effective and without medically significant side-effects in inducing weight loss in previously refractory obese patients. However, the formula was poorly tolerated due to taste problems and irregular batch consistency.

IV. ThermoBean™ Open-label Concept Trial This trial (currently on-going as of Feb.,2000) is intended to evaluate the global concept of the ”Four Principles” using the powdered sprinkle ThermoBean™ formula.

V. ThermoBean™ Body Composition Evaluation V ThermoBean™ Energy Enhancement Evaluation currently in progress.

VI. ThermoBean™ Diabetes/ Renal Function Trial. Ongoing, after three months, no Renal deterioration nor adverse change in Protein Euria has been observed.

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Thermogenesis | Ephedra Alkaloids | Legumes as Health Food
Clinical Trials