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The Safety and Efficacy of a Dietary Herbal Supplement and Gallic Acid for Weight Loss
Frank L. Greenway,Andrew T. Roberts,Corby K. Martin,Zhijun Liu,Ronald J. Amen,Eugene A. Woltering,Jennifer C. Rood,Mary K. Caruso,Ying Yu,Hui Xie 한국식품영양과학회 2007 Journal of medicinal food Vol.10 No.1
The objective of this study was to test the safety and efficacy of NT, a dietary herbal supplement made fromrhubarb, ginger, astragulus, red sage, and turmeric, combined with gallic acid (GA) to reduce food intake and cause weightloss. A total of 105 healthy subjects, 1860 years old with a body mass index of 2535 kg/m2 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 divideddoses 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 mg NT-GA combination and 800 g GA alone were performed with and withoutfood. There was no dose-related weight loss or reduction in food intake at the 8-week analysis, and the study was terminatedearly. Pharmacokinetic studies showed plasma levels of GA did not increase above 10 .M and were not dose-related. TheNT-GA at all concentrations was well tolerated, but was ineffective in causing weight loss or in suppressing food intake. Phar-macokinetics suggested that GA plasma levels were limited by oral absorption, and may be the reason for lack of efficacy.