Long-term Effects of Green Tea on Gut Flora, Fat Absorption, Body Composition and Resting Energy Expenditure
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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.
- 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 |
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| Contact: Pilou Janssens, MSc | 043-3884596 | plhr.janssens@maastrichtuniversity.nl |
| Contact: Rick Hursel, Dr | 0.358 | rick.hursel@maastrichtuniversity.nl |
| 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. | |
| 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 May 16, 2013