A short pilot study was conducted to test the impact of a supplement regimen, in conjunction with dietary and exercise advice, on weight loss and physique modification in overweight volunteers. The daily regimen provided the following, to be consumed in three equal doses: calcium pyruvate, 12 g; HCA, 1.5 g; L-carnitine, 250 mg; chromium (as chromic tripicolinate), 600 .mu.g. The supplements were to be consumed in the morning (prior to exercise or eating), with lunch and at bedtime. Participants were asked to walk at least 20 minutes each morning, on an empty stomach and at a brisk pace at which they could converse normally. Dietary advice consisted of recommendations to eat a high-protein, low-fat diet (30% and 10% of calories, respectively) in an amount that provided 0.75-1 g protein per pound of lean mass daily (or 100 g daily for women with lean mass under 100 pounds). These recommendations corresponded to total daily caloric intakes of 1,300-3,100 kcal daily, dependent on body size; the average recommended intake was about 2,000 kcal daily which was to be consumed in numerous small meals daily, and no calories were to be ingested in the three hours prior to bedtime.

Body composition was evaluated at baseline and at weekly intervals thereafter using Futrex 5000.TM., an infrared technique for quantifying the depth of underlying subcutaneous fat (Conway et al., Am. J. Clin. Nutr. 40:1123-1130, 1984; Elia et al., Eur. J. Clin. Nutr. 44:113-121, 1990). All measurements were made at a standardized distance up the upper arm between the heads of the biceps. On each occasion, except the last, measurements were taken in triplicate and averaged. Heights and weights were also determined, thus enabling calculation of body mass index (BMI), a standard measure of obesity which is defined as the weight divided by the square of the height.

A total of 23 volunteers, the majority Samoan-American, appeared for enrollment and admitted in three groups on dates A, B and C; final evaluation was on date D. The time periods between dates A-D, B-D and C-D were 28 days, 24 days and 21 days, respectively. Three subjects did not return after baseline evaluation, and one subject did not return for final evaluation. Two subjects refused to be weighed at baseline (insisting on "reporting" their own weights) and therefore could not be properly assessed. One subject developed a rash after three days, and pyruvate administration was discontinued. Thus, 16 of the participants were able to be evaluated. The initial body weights of the subjects ranged from 69 kg to 231 kg, with a mean weight of 117 kg. Percentage body fat ranged from 26% to 54%, with a mean value of 41%. The average BMI was 39.3 (range 26.2-63.7).

Most subjects tolerated the regimen quite well. As noted, one subject developed a rash and was discontinued in the study. The largest enrolled subject (initial weight 231 kg), who also lost the most weight and fat, had a prior history of gout, and experienced an attack of gout during the final week which prevented him from walking. One subject noted borborygmus (intestinal rumbling) and gas.

Most subjects reported feeling warm during the study, in the first week, three subjects reported sweating and/or subjective feelings of heat (including a woman who at baseline had complained that she was always cold). Since this was thought to be a possible sign of increased thermogenesis, the other subjects were queried as to whether they were experiencing sensations of warmth, and the subjects were virtually unanimous in affirming this. On subject (again, the largest one) noted profuse sweating and indicated that he needed to turn a fan on himself at bedtime in order to sleep. The other virtually unanimous subjective response was of considerably increased physical energy.

Self-reported compliance with the dietary and exercise recommendations was excellent in many subjects, but others confessed to occasional junk food binges, a failure to achieve the suggested intake of protein or sporadic adherence to morning walking exercise. Self-reported compliance with the supplement regimen in general was quite good, although a few subjects noted that they had missed several doses. Participants were free living and, with the exception of a whey supplement provided to several subjects, their food was self-chosen. Exercise was not monitored. Thus, the conditions of the study were closer to "real world" application than is the case in most carefully supervised clinical studies. Furthermore, no subjects were excluded from the final analysis owing to sporadic (or, in a few instances, non-existent) compliance with dietary, exercise or supplementation recommendations.

Since subjects were enrolled for varying period of time (3-4 weeks), results are reported as average weight loss and average fat loss per week. In the entire group of 16 subjects, average weekly weight loss was 1.5 kg (3.3 lb) and average weekly fat loss was 2.3 kg (5.1 lb). This implies a weekly gain of lean mass averaging 0.8 kg. The largest subject achieved, within 24 days, a weight loss of 11.8 kg (26 lb) and, remarkably, a fat loss of 22.7 kg (50 lb). If this subject is excluded from the analysis as atypical, the average weekly weight and fat losses in the remaining 15 subjects were 1.4 kg (3.1 lb) and 2.0 kg (4.4 lb), respectively.

Since grossly obese subjects have often been noted to lose significant weight initially when their diet is regulated (preventing binges on favorite foods), a separate analysis was made of the five subjects with an initial weight under 200 pounds (91 kg). In these subjects, average weekly weight loss and fat loss averaged 1.3 kg (2.9 lb) and 1.8 kg (4 lb), respectively which was not greatly different from the group as a whole. The subject with the lowest body weight, as well as the subject with the lowest initial percentage body fat, achieved weekly rates of fat loss of 2.0 and 2.7 kg (4.4 and 6 lb), respectively. Thus, the benefit does not appear to be contingent on severe obesity. The poorest response was noted in a 74 kg woman who lost 3.2 kg ((7 lb) and 4.5 kg (9.9 lb) of fat over four weeks. During the final week, she had been completely noncompliant with the diet and exercise recommendations.

These results demonstrate a marked synergism between pyruvate and HCA/carnitine. When used in conjunction with low-calorie diets or an overfeeding regimen, pyruvate (at 15-30 g daily) diminished body fat by about 1 kg over 21 days relative to placebo (Stanko et al., Am. J. Clin. Nutr. 55:771-776, 1992; Stanko et al., Am. J. Clin. Nutr. 56:630-635, 1992; Stanko et al., Int. J. Obesity 20:925-930, 1996). In the context of a low-fat weight-maintaining regimen in hyperlipidemic subjects, about half of whom were obese, the incremental fat loss associated with pyruvate (22-44 g daily) was 0.4 kg over six weeks (Stanko et al., Am. J. Clin. Nutr. 59:423-427, 1994). In a double-blind study in which overweight volunteers received HCA/carnitine/chromium picolinate while asked to avoid fatty foods, eat more fiber, and get more physical activity, the additional fat loss attributable to the supplement was 0.6 kg over four weeks (Kaats et al., oral presentation, 3rd International Conference on Anti-Aging Medicine and Biomedical Technology, Las Vegas, 1995). Used alone, either of these techniques appears to have some utility, but they should be considered as adjuvants to traditional weight management techniques. In contrast, the results reported herein with the combined use of these measures are clearly far greater than the sum of their individual efficacies and constitute a new and definitive approach to obesity control.

It is also notable that, in every subject, lean body mass increased during the study. Thus, the response was quite different from that seen during very low calorie dieting. The subjective increase in energy (which helped some subjects comply with the recommended exercise) and in body warmth is also hardly typical of response during caloric deprivation. Perhaps the most telling indication of the success of the regimen were the dozens of friends and relatives of the volunteers who demanded to be included in the study.

If one assumes that a pound of fat corresponds to about 3,500 kcal, whereas a pound of lean averages 700 kcal, the average daily caloric deficit was approximately 2,370 kcal (2,100 kcal if the heaviest subject is excluded from the analysis). Given the fact that the subjects were not subjected to severe caloric restriction (indeed, a few complained that they were being asked to eat too much), and were asked to do only walking exercise of modest duration, these responses are likely to be unprecedented and are strongly suggestive of a dramatic increase in thermogenesis. The average monthly weight loss, approximately 6.5 kg (14.3 lb) is exceptional in the context of a regimen that does not include severe caloric restriction, draconian exercise or drugs.

The above description of the invention is set forth solely to assist in understanding the invention. It is to be understood that variations of the invention, including all equivalents now known or later developed, are to be considered as falling within the scope of the invention, which is limited only by the following claims.

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