Maastricht University, Human Biology
Maastricht, 6229 ER, Netherlands
NCT Number: NCT01556321
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.
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Notify Me18 year–50 year
All sexes
Interventional
Not applicable
Maastricht, 6229 ER, Netherlands
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects will receive placebo (soy oil; 757 mg/capsule, 3 capsules with each breakfast, lunch and dinner) in capsule form after their baseline measurement, which they have to consume daily for a period of twelve weeks.
Subjects will receive green tea (757 mg/capsule [84.5 mg EGCG + 2.1 mg caffeine ], 3 capsules with each breakfast, lunch and dinner)in capsule form after their baseline measurement, which they have to consume daily for a period of twelve weeks.
Time frame: 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.
Time frame: At three time points (baseline, 6 weeks and 12 weeks)
Time frame: At three time points (baseline, 6 weeks and 12 weeks)
Time frame: At three time points (baseline, 6 weeks and 12 weeks)
Time frame: At three time points (baseline, 6 weeks and 12 weeks)
Time frame: At three time points (baseline, 6 weeks and 12 weeks)
Maastricht University Medical Center
Other
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