BACKGROUND: Obesity is a well-established risk factor for cardiovascular diseases, diabetes, hypertension, arteriosclerosis and stroke. Stimulants such as ephedrine and caffeine and their herbal counterparts have been proved effective in reducing body mass; however, their use is controversial due to the undesired effects. Therefore, it is necessary to find a tolerable and effective nutraceutical that can increase energy expenditure and/or decrease calorie intake to reduce weight.OBJECTIVE: To assess the effects of a preparation containing node of Lotus Rhizome, green tea, and Panax notoginsengin reducing body mass and fat in obese adults.DESIGN: Randomized, double blind, placebo-controlled study using the volunteers as the subjects.SETTING: Institute of Natural Drug of Yunnan Baiyao Group.PARTICIPANTS: The trial was conducted in the Institute of Natural Drug of Yunnan Baiyao Group from July 5 to August 23 in 2003. Altogether 82 obese volunteers[35 men and 47 women aged 26- 50 years, body mass index (BMI) ≥ 25 kg/m2 ] were randomly assigned to treatment and placebo groups with 41 in each group.METHODS: The treatment group received 9 g pill of a dietary supplement containing a proprietary blend of node of Lotus Rhizome, green tea and Panax notoginseng every day for 7 weeks, while the placebo group received 9 g pill of rice flour every day for 7 weeks. Their body mass, percentage of body fat,absolute fat mass, BMI, waist and hip circumference, and anthropometric measurements were recorded at the beginning and the end of the study. The subjects completed daily dietary intake records on days 1 to 3 and 47 to 49. They also completed weekly activity logs throughout the study.MAIN OUTCOME MEASURES: ① Final outcome indexes: body mass,percentage of body fat, BMI, waist and hip circumference; ② Replacement indexes: diet, heart rate, oxygen consumption and blood pressure; ③ Risk indexes: adverse events and side effects.RESULTS: Four subjects (1 from the treatment group and 3 from the placebo group) dropped out for personal reasons unrelated to the study. No significant changes were found in the consumption of total calories, percentage of calories ingested as carbohydrates, fat or protein, or activity levels in either group throughout the study. Body mass, percentage of body fat and BMI of the treatment group were(74.7 ± 11.4) kg, (33.0±4. 1)% and(28.5±2.7) kg/m2 before the experiment, and(73.6 ± 12.4) kg, (31.3 ±4.5)%and(27.9 ± 3.0) kg/m2 at week 7, with significant differences. Waist and hip circumference of the treatment group was obviously decreased, but did not differ significantly before and after the experiment in the placebogroup. There were no significant differences in heart rate, oxygen consumption and blood pressure between the two groups. No obvious side effects were observed in the two groups.CONCLUSION: The novel combination of node of Lotus Rhizome, green tea and Panax notoginseng can significantly reduce body mass and fat in obese adults.