To investigate the long-term effects of green tea on gut flora, fat absorption, resting energy expenditure and body composition.
ID
Source
Brief title
Condition
- Appetite and general nutritional disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of this study is the possible change in gut flora and fat
absorption.
Secondary outcome
Secondary study parameters/endpoints are resting energy expenditure and body
composition.
Background 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.
Study objective
To investigate the long-term effects of green tea on gut flora, fat absorption,
resting energy expenditure and body composition.
Study design
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).
Intervention
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.
Study burden and risks
The study does not include any major risk for the subjects. The collection of
faeces will be harmless. Anthropometric and body composition measurements will
not be invasive for the subjects. Deuterium dilution has been shown to be a
safe method for determining total body water and thereby body composition.
Furthermore, the air in the hood is continuously regulated.
Administering green tea will not form any health risk. Green tea is a natural
product, which is safe in the given dose.
Universiteitssingel 50
Maastricht 6229 ER
NL
Universiteitssingel 50
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
A total of 100 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 healthy, weight stable, dietary unrestraint, not using a more than moderate amount of alcohol (>10 consumptions/wk) or 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 and not using antibiotics during the last 6 months. The Dutch translation of the Three Factor Eating Questionnaire (TFEQ) will be used to determine eating behaviour (10). Non-restrained eaters (<9 times factor 1), these are persons who are not consciously occupied with food and who are not caloric restricted, will be selected. Subjects will be free of medication except for oral contraceptives use in women.
Exclusion criteria
Subjects will be excluded if they are not healthy, smoking, using a more than moderate
amount of alcohol or 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 or if they do not meet the criteria for BMI and age. Pregnant and lactating women, and subjects with allergies for the used food items will also be excluded from participation.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01556321 |
| CCMO | NL38773.068.11 |