藕节、绿茶及三七微丸制剂干预成年性肥胖

Preparation-containing node of Lotus Rhizome,green tea and Panax notoginseng for obese adults

背景:肥胖是一个已确立的心血管疾病、糖尿病、高血压、动脉硬化和脑卒中的危险因素。一些激动剂,如麻黄素、咖啡因以及它们的草药类似物质已被证明有减轻体质量的作用,但是对它们的使用因其副反应而有争议。因此,一种能增加能量消耗或减少热量摄入,减肥有效而又能耐受的营养性制剂,是合乎需要的。目的:评估一种含藕节,绿茶及三七成分的新颖微丸制剂,对成年肥胖者体质量和脂肪的减少效果。设计:以自愿者为观察对象,随机,双盲,安慰剂对照实验。单位:云南白药集团天然药物研究院。对象:实验于2003-07-05/08-23在云南白药集团天然药物研究院完成。自愿者82例,男35例,女47例;年龄26～50岁;体质量指数≥25kg/m2。随机分为处理组和安慰剂组,每组各41例。方法:处理组口服含藕节、绿茶及三七微丸制剂(千草美姿减肥旨安微丸)9g/d;安慰剂组每天口服淀粉制作微丸9g/d,实验周期为7周。测量实验起始和实验结束时的体质量,体脂百分含量,脂肪绝对质量,体质量指数,腹围和臀围,以及其他人体测量指标。实验最初3d和实验末尾3d记录摄食情况。受试者记录每周的活动情况。主要观察指标:①终点结局指标:两组体质量、身体脂肪含量、体质量指数、腹围及臀围。②替代指标:两组饮食、心率、耗氧量和血压情况。③危险性指标:不良事?

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 notoginseng in 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:①Final outcome indexes:body mass,percentage of body fat,BMI,waist and hip circumference;②Replacement indexes:diet,heart rate,oxygen consumption and blood pressure;③Risk 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 placebo group.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.