The human dose equivalent of NT used in this study was & frac16; and & frac112; of that shown to give well-tolerated weight loss in rodents. Number Ten will not be an effective dietary herbal supplement for the treatment of obesity owing to dose-limiting gastrointestinal toxicity.
The objective of this study was to test the safety and efficacy of NT, a dietary herbal supplement made from rhubarb, ginger, astragulus, red sage, and turmeric, combined with gallic acid (GA) to reduce food intake and cause weight loss. A total of 105 healthy subjects, 18-60 years old with a body mass index of 25-35 kg/m(2) and on no chronic medication, were randomized to a 300 mg/1.2 g NT-GA combination, a 600 mg/2.4 g NT-GA combination, or placebo in three divided doses daily for 24 weeks. Food intake was measured at baseline and 2 weeks, and safety parameters were followed regularly. Pharmacokinetic studies of a 200 mg/800 g NT-GA combination and 800 mg GA alone were performed with and without food. There was no dose-related weight loss or reduction in food intake at the 8-week analysis, and the study was terminated early. Pharmacokinetic studies showed plasma levels of GA did not increase above 10 microM and were not dose-related. The NT-GA at all concentrations was well tolerated, but was ineffective in causing weight loss or in suppressing food intake. Pharmacokinetics suggested that GA plasma levels were limited by oral absorption, and may be the reason for lack of efficacy.
The combination of NT and gallic acid gave no evidence of reproductive toxicity at 430 mg/kg per day or below, which is reassuring should this combination be used in the future as a dietary herbal supplement for the treatment of obesity.
Fiber-free liquid diets containing isonitrogenous amounts of various dietary nitrogen sources were fed to five adult male pig-tailed monkeys (Macaca nemestrina) with a mean weight of approximately 10 kg. All liquid diets supplied 3.0 g N/DAY PER MONKEY AND MAINTAINED THE ANIMALS IN A POSTIVE NITROGEN BALANCE. Initial baseline fecal output data were obtained by feeding the animals a commercial solid monkey chow. The dietary nitrogen sources fed were a) egg white protein, b) an enzymatic hydrolysate of fish protein supplemented with L-amino acids to simulate the egg albumin pattern, c) a mixture of pure L-amino acids simulating the egg pattern, d) a casein hydrolysate supplemented with amino acids, and e) an amino acid mixture with Rose's pattern. Total fecal matter, dry fecal matter, percent of moisture, fecal nitrogen, lipids and ash were determined for a 10-day period for each experimental diet. A very significant difference (P smaller than 0.001) was noted between each liquid diet and the solid chow, but no significant differences were found between the various fiber-free liquid diets, pointing to the effect of fiber as a major factor affecting fecal output. Monkeys fed liquid diets excreted fecal matter with a mean of 12.9 g/day, of which 4.7 g/day was dry feces (fecal dry matter 28.5%). Fecal nitrogen was found to be 0.25 g, fecal lipids were 0.19 g, and fecal ash was 0.59 g/day per monkey, respectively.
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