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

NCT ID: NCT01556321

Last Updated: 2016-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2015-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type EXPERIMENTAL

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

Intervention Type 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.

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type 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, 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

Group Type EXPERIMENTAL

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

Intervention Type 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.

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Margriet Westerterp-Plantenga, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Maastricht University, department of human biology

Locations

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Maastricht University, Human Biology

Maastricht, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type BACKGROUND
PMID: 21366839 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19597519 (View on PubMed)

Janssens PL, Penders J, Hursel R, Budding AE, Savelkoul PH, Westerterp-Plantenga MS. Long-Term Green Tea Supplementation Does Not Change the Human Gut Microbiota. PLoS One. 2016 Apr 7;11(4):e0153134. doi: 10.1371/journal.pone.0153134. eCollection 2016.

Reference Type DERIVED
PMID: 27054321 (View on PubMed)

Janssens PL, Hursel R, Westerterp-Plantenga MS. Long-term green tea extract supplementation does not affect fat absorption, resting energy expenditure, and body composition in adults. J Nutr. 2015 May;145(5):864-70. doi: 10.3945/jn.114.207829. Epub 2015 Mar 4.

Reference Type DERIVED
PMID: 25740906 (View on PubMed)

Other Identifiers

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NL38773

Identifier Type: -

Identifier Source: org_study_id

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