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

Sponsor

Maastricht University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01556321

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Obesity	Dietary Supplement: placebo Dietary Supplement: green tea (757 mg/capsule [84.5 mg EGCG + 2.1 mg caffeine ]	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Jun 1, 2012

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Green tea, normal weight 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	Dietary Supplement: green tea (757 mg/capsule [84.5 mg EGCG + 2.1 mg caffeine ] 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.
Placebo Comparator: Placebo, normal weight 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	Dietary Supplement: placebo 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.
Experimental: Green tea, overweight Subjects with a BMI >30 kg/m2 will receive green tea capsules, which they have to consume daily for a period of twelve weeks	Dietary Supplement: green tea (757 mg/capsule [84.5 mg EGCG + 2.1 mg caffeine ] 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.
Placebo Comparator: Placebo capsules, obese Subjects with a BMI >30 kg/m2 will receive placebo capsules, which they have to consume daily for a period of twelve weeks	Dietary Supplement: placebo 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.

Outcome Measures

Primary Outcome Measures

Faeces are collected for analyzing the gut flora and fat absorption [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.

Secondary Outcome Measures

Resting energy expenditure (REE) [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 composition: BMI, body fat percentage, fat mass index (FMI) [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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

BMI between 18.5-25 kg/m2 and ≥30 kg/m2
Age between 18-50 years
Healthy
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.

Exclusion Criteria:

Not healthy
Smoking
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.