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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01556321
• Other study ID #: NL38773
• Status: Completed
• Phase: N/A
• First received: March 7, 2012
• Last updated: March 17, 2016
• Start date: June 2012
• Est. completion date: April 2015

Study information

• Verified date: May 2013
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Obesity

Intervention

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.
• 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.

Locations

Country	Name	City	State
Netherlands	Maastricht University, Human Biology	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

Hursel R, Viechtbauer W, Dulloo AG, Tremblay A, Tappy L, Rumpler W, Westerterp-Plantenga MS. The effects of catechin rich teas and caffeine on energy expenditure and fat oxidation: a meta-analysis. Obes Rev. 2011 Jul;12(7):e573-81. doi: 10.1111/j.1467-789X.2011.00862.x. Epub 2011 Mar 2. Review. — View Citation

Hursel R, Viechtbauer W, Westerterp-Plantenga MS. The effects of green tea on weight loss and weight maintenance: a meta-analysis. Int J Obes (Lond). 2009 Sep;33(9):956-61. doi: 10.1038/ijo.2009.135. Epub 2009 Jul 14. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Faeces are collected for analyzing the gut flora and fat absorption	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.	At three time points (baseline, 6 weeks and 12 weeks)	No
Secondary	Resting energy expenditure (REE)		At three time points (baseline, 6 weeks and 12 weeks)	No
Secondary	Respiratory quotient (RQ)		At three time points (baseline, 6 weeks and 12 weeks)	No
Secondary	Three frequency eating questionnaire (TFEQ)		At three time points (baseline, 6 weeks and 12 weeks)	No
Secondary	Body composition: BMI, body fat percentage, fat mass index (FMI)		At three time points (baseline, 6 weeks and 12 weeks)	No
Secondary	Body fat distribution: waist circumference, waist-to-hip ratio (WHR		At three time points (baseline, 6 weeks and 12 weeks)	No