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
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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COMPLETED
NA
70 participants
INTERVENTIONAL
2012-06-30
2015-04-30
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
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
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, 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
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, 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
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 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
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
50 Years
ALL
Yes
Sponsors
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Maastricht University Medical Center
OTHER
Responsible Party
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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
Countries
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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.
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.
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.
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.
Other Identifiers
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NL38773
Identifier Type: -
Identifier Source: org_study_id
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