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OpenTrials
Completed

NCT Number: NCT01556321

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

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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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University, Human Biology

Maastricht, 6229 ER, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Dietary Supplement

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.

green tea (757 mg/capsule [84.5 mg EGCG + 2.1 mg caffeine ]

Dietary Supplement

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.

Primary outcomes

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

    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.

Secondary outcomes

  1. Resting energy expenditure (REE)

    Time frame: At three time points (baseline, 6 weeks and 12 weeks)

  2. Respiratory quotient (RQ)

    Time frame: At three time points (baseline, 6 weeks and 12 weeks)

  3. Three frequency eating questionnaire (TFEQ)

    Time frame: At three time points (baseline, 6 weeks and 12 weeks)

  4. Body composition: BMI, body fat percentage, fat mass index (FMI)

    Time frame: At three time points (baseline, 6 weeks and 12 weeks)

  5. Body fat distribution: waist circumference, waist-to-hip ratio (WHR

    Time frame: At three time points (baseline, 6 weeks and 12 weeks)

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Mar 16, 2012
Registry last updated
Mar 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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