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临床试验/NCT01556321
NCT01556321已完成不适用

Long-term Effects of Green Tea on Gut Flora, Fat Absorption, Body Composition and Resting Energy Expenditure

Maastricht University Medical Center1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2012年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
Faeces are collected for analyzing the gut flora and fat absorption

研究概览

简要总结

Green tea may have positive effects for weight control and on body composition via several approaches such as a positive effect on the gut flora, a decrease in fat absorption from the intestines and an increase in resting energy expenditure.

详细描述

Green tea may have positive effects for weight control and on body composition via several approaches such as a positive effect on the gut flora, a decrease in fat absorption from the intestines and an increase in resting energy expenditure. We would like to investigate the long-term effects of green tea on gut flora, fat absorption, resting energy expenditure and body composition.

The study will be conducted in a randomized, placebo-controlled, double-blind parallel design with four groups consisting of control groups and green tea groups with normal weight subjects and obese subjects. At three time points (baseline, 6 weeks and 12 weeks) faeces are collected for analyzing the gut flora composition and fat content. Furthermore, measurements of resting energy expenditure and body composition will be conducted. Activity will be measured during three weeks (baseline, week 6 and week 12).

a hundred healthy subjects (50 males and 50 females) with a BMI between 18.5-25 kg/m2 and ≥30 kg/m2 and aged between 18-50 years will be included in the study. All subjects will be non-smoking, non tea-drinkers, weight stable, dietary unrestraint, and at most moderate alcohol and caffeine consumers. Subjects will be free of medication except for oral contraceptives use in women.

Intervention (if applicable):

Subjects will receive either green tea or placebo in capsule form after their baseline measurement, which they have to consume three times daily for a period of twelve weeks.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •BMI between 18.5-25 kg/m2 and ≥30 kg/m2
  • •Age between 18-50 years
  • •Weight stable
  • •Dietary unrestraint
  • •Not using a more than moderate amount of alcohol (>10 consumptions/wk)
  • •Not using more than 100 mg caffeine per day
  • •Not drinking tea
  • •Not using probiotics
  • •Being weight stable (weight change < 3kg during the last 6 months)
  • •Dietary unrestraint
  • •Not using antibiotics during the last 6 months.
  • •Free of medication except for oral contraceptives use in women.

排除标准

  • •Not healthy
  • •Using a more than moderate amount of alcohol
  • •Using more than 100 mg caffeine per day
  • •Drinking tea
  • •Using probiotics
  • •Not being weight stable
  • •Dietary restraint
  • •Using medication or supplements except for oral contraceptives in women
  • •Using antibiotics
  • •Not meeting the criteria for BMI and age.
  • •Pregnant or lactating women
  • •Having allergies for the used food items will also be excluded from participation.

研究组 & 干预措施

Green tea, normal weight

Experimental

Subjects with a BMI 18.5-25 kg/m2 will receive green tea capsules, which they have to consume daily for a period of twelve weeks

干预措施: green tea (757 mg/capsule [84.5 mg EGCG + 2.1 mg caffeine ] (Dietary Supplement)

Placebo, normal weight

Placebo Comparator

Subjects with a BMI 18.5-25 kg/m2 will receive placebo capsules, which they have to consume daily for a period of twelve weeks

干预措施: placebo (Dietary Supplement)

Green tea, overweight

Experimental

Subjects with a BMI >30 kg/m2 will receive green tea capsules, which they have to consume daily for a period of twelve weeks

干预措施: green tea (757 mg/capsule [84.5 mg EGCG + 2.1 mg caffeine ] (Dietary Supplement)

Placebo capsules, obese

Placebo Comparator

Subjects with a BMI >30 kg/m2 will receive placebo capsules, which they have to consume daily for a period of twelve weeks

干预措施: placebo (Dietary Supplement)

结局指标

主要结局

Faeces are collected for analyzing the gut flora and fat absorption

时间窗: At three time points (baseline, 6 weeks and 12 weeks)

The primary endpoint of this study is the change in gut flora; ratio firmicutes/bacteroidetes, changes in total faecal fat and change in body weight.

次要结局

  • Resting energy expenditure (REE)(At three time points (baseline, 6 weeks and 12 weeks))
  • Body composition: BMI, body fat percentage, fat mass index (FMI)(At three time points (baseline, 6 weeks and 12 weeks))
  • Respiratory quotient (RQ)(At three time points (baseline, 6 weeks and 12 weeks))
  • Three frequency eating questionnaire (TFEQ)(At three time points (baseline, 6 weeks and 12 weeks))
  • Body fat distribution: waist circumference, waist-to-hip ratio (WHR(At three time points (baseline, 6 weeks and 12 weeks))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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