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临床试验/NCT00302276
NCT00302276已完成2 期

Weight Loss Maintenance of a New Bioactive Compound (Metobes-Long)

University of Copenhagen2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2004年1月最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
80
试验地点
2
主要终点
Body weight, fat mass, fat free mass, energy expenditure, respiratory quotient, fecal fat, fecal energy

研究概览

简要总结

The objective of the present study was to investigate the acute and sub-chronic effect of a supplement containing green tea extract, capsaisin, caffeine, tyrosine and calcium or placebo taken t.i.d on thermogenesis, body fat loss, and fecal fat excretion. Furthermore, if a 8-week supplementation could prevent weight-regain after initial 4-week weight loss.

详细描述

It has previously been shown that a combination of tyrosine, capsaicin, catechines, and caffeine may stimulate the sympathetic nervous system and promote satiety, lipolysis and thermogenesis. In addition, dietary calcium may increase fecal fat excretion.

Method:

80 healthy Danish overweight to obese (BMI between 28 and 35 kg/m2), 18 to 70 years of age subjects of both gender. All subjects was be weight stable (within 3-kg) 2 months prior to study inclusion, non-smoking, non-athletic and have no daily use of medication except for anticonception and antihypertensive compounds. All subjects gave their written consent after verbal and written information about the study. The study protocol was approved by The Municipal Ethical Committee of Copenhagen and Frederiksberg as being in accordance with the Helsinki II Declaration.

The total study period was 12 weeks. The intervention design was an 8-weeks randomized, 3-arm parallel, placebo-controlled and double-blind intervention. Prior to the randomized intervention a weight loss was initiated by 4 week treatment on a 3.4 MJ/d low caloric diet (LCD). Only subject who lost more than 4% of their initial body weight after 4 weeks LCD treatment was randomized and continued in the study.

The subjects were randomized into 3 balanced groups i.e. placebo, simple or enterocoated release. All subjects received dietary instruction to a slightly hypo caloric diet of -300 kcal/day after the isoenergetic educational system. The dietary advice was reinforced by dietetic consultations every fortnight.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • healthy Danish overweight to obese (BMI between 28 and 35 kg/m2), 18 to 70 years of age subjects of both gender. All subjects must be weight stable (within 3-kg) 2 months prior to study inclusion.

排除标准

  • smokers, athletic, daily use of medication except for anticonception and antihypertensive compounds, blood pressure above 165/95 mmHg

结局指标

主要结局

Body weight, fat mass, fat free mass, energy expenditure, respiratory quotient, fecal fat, fecal energy

次要结局

  • blood pressure, heart rate, urine catecholamines, self-reported adverse events

研究者

申办方类型
Other

研究点 (2)

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