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

This study is currently recruiting participants.
Verified May 2013 by Maastricht University Medical Center
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01556321
First received: March 7, 2012
Last updated: May 16, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Obesity
Dietary Supplement: placebo
Dietary Supplement: green tea (757 mg/capsule [84.5 mg EGCG + 2.1 mg caffeine ]

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Long-term Effects of Green Tea on Gut Flora, Fat Absorption, Body Composition and Resting Energy Expenditure

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Faeces are collected for analyzing the gut flora and fat absorption [ Time Frame: At three time points (baseline, 6 weeks and 12 weeks) ] [ Designated as safety issue: No ]
    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) [ Time Frame: At three time points (baseline, 6 weeks and 12 weeks) ] [ Designated as safety issue: No ]
  • Respiratory quotient (RQ) [ Time Frame: At three time points (baseline, 6 weeks and 12 weeks) ] [ Designated as safety issue: No ]
  • Three frequency eating questionnaire (TFEQ) [ Time Frame: At three time points (baseline, 6 weeks and 12 weeks) ] [ Designated as safety issue: No ]
  • Body composition: BMI, body fat percentage, fat mass index (FMI) [ Time Frame: At three time points (baseline, 6 weeks and 12 weeks) ] [ Designated as safety issue: No ]
  • Body fat distribution: waist circumference, waist-to-hip ratio (WHR [ Time Frame: At three time points (baseline, 6 weeks and 12 weeks) ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01556321

Contacts
Contact: Pilou Janssens, MSc 043-3884596 plhr.janssens@maastrichtuniversity.nl
Contact: Rick Hursel, Dr 0.358 rick.hursel@maastrichtuniversity.nl

Locations
Netherlands
Maastricht University, Human Biology Recruiting
Maastricht, Netherlands, 6229 ER
Contact: Margriet S Westerterp-Plantenga, Prof. dr.    043-3881566    m.westerterp@maastrichtuniversity.nl   
Principal Investigator: Margriet S Westerterp-Plantenga, Prof. Dr.         
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Margriet Westerterp-Plantenga, Prof. Dr. Maastricht University, department of human biology
  More Information

Publications:
Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01556321     History of Changes
Other Study ID Numbers: NL38773
Study First Received: March 7, 2012
Last Updated: May 16, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Obesity
Body weight
Gut flora
Fat absorption

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on April 17, 2014