ObesityNCT01556321
Long-term Effects of Green Tea on Gut Flora, Fat Absorption, Body Composition and Resting Energy Expenditure
A study testing green tea (757 mg/capsule [84.5 mg EGCG + 2.1 mg caffeine ] in people with Obesity, run by Maastricht University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- green tea (757 mg/capsule [84.5 mg EGCG + 2.1 mg caffeine ]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2012to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Show all 13Show fewer
- 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.
Who cannot join
- Not healthy
- Smoking
- Using a more than moderate amount of alcohol
- Using more than 100 mg caffeine per day
- Drinking tea
- Using probiotics
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University, Human Biology
Maastricht, 6229 ER
About this study
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- placebo, green tea (757 mg/capsule [84.5 mg EGCG + 2.1 mg caffeine ]
- Keywords
- Obesity, Body weight, Gut flora, Fat absorption
- Medical subject headings
- Obesity, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDietary 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 (757 mg/capsule [84.5 mg EGCG + 2.1 mg caffeine ]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.
| Study group | Role | What they receive |
|---|---|---|
| Green tea, normal weight | Experimental | 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 Receives: Dietary Supplement: green tea (757 mg/capsule [84.5 mg EGCG + 2.1 mg caffeine ] |
| Placebo, normal weight | Placebo comparator | 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 Receives: Dietary Supplement: placebo |
| Green tea, overweight | Experimental | Subjects with a BMI >30 kg/m2 will receive green tea capsules, which they have to consume daily for a period of twelve weeks Receives: Dietary Supplement: green tea (757 mg/capsule [84.5 mg EGCG + 2.1 mg caffeine ] |
| Placebo capsules, obese | Placebo comparator | Subjects with a BMI >30 kg/m2 will receive placebo capsules, which they have to consume daily for a period of twelve weeks Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At three time points (baseline, 6 weeks and 12 weeks)
Secondary outcomes (5)
Resting energy expenditure (REE)
Measured: At three time points (baseline, 6 weeks and 12 weeks)
Respiratory quotient (RQ)
Measured: At three time points (baseline, 6 weeks and 12 weeks)
Three frequency eating questionnaire (TFEQ)
Measured: At three time points (baseline, 6 weeks and 12 weeks)
Body composition: BMI, body fat percentage, fat mass index (FMI)
Measured: At three time points (baseline, 6 weeks and 12 weeks)
Body fat distribution: waist circumference, waist-to-hip ratio (WHR
Measured: At three time points (baseline, 6 weeks and 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Margriet Westerterp-Plantenga, Prof. Dr., Principal investigator, Maastricht University, department of human biology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01556321
- Sponsor's protocol ID
- NL38773
- Status last verified
- May 2013
- First submitted
- 7 Mar 2012
- Last updated
- 18 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21366839Hursel 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.
PubMed 19597519Janssens 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.
PubMed 27054321Janssens 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.
PubMed 25740906
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effects of Green Tea on Gut Flora, Fat Absorption, Body Composition and Resting Energy Expenditure
- ClinicalTrials.gov ID
- NCT01556321
- Acronym / sponsor ID
- NL38773
- Conditions
- Obesity
- Keywords
- Obesity, Body weight, Gut flora, Fat absorption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 16 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Green tea, normal weight | Experimental | Dietary Supplement: green tea (757 mg/capsule [84.5 mg EGCG + 2.1 mg caffeine ]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 |
| Placebo, normal weight | Placebo comparator | Dietary Supplement: placeboSubjects with a BMI 18.5-25 kg/m2 will receive placebo capsules, which they have to consume daily for a period of twelve weeks |
| Green tea, overweight | Experimental | Dietary Supplement: green tea (757 mg/capsule [84.5 mg EGCG + 2.1 mg caffeine ]Subjects with a BMI >30 kg/m2 will receive green tea capsules, which they have to consume daily for a period of twelve weeks |
| Placebo capsules, obese | Placebo comparator | Dietary Supplement: placeboSubjects with a BMI >30 kg/m2 will receive placebo capsules, which they have to consume daily for a period of twelve weeks |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- BMI between 18.5-25 kg/m2 and ≥30 kg/m2
- Age between 18-50 years
- Healthy
- Weight stable
- Dietary unrestraint
Key exclusion criteria (13 listed)
- Not healthy
- Smoking
- Using a more than moderate amount of alcohol
- Using more than 100 mg caffeine per day
- Drinking tea
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placeboSubjects 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. | Dietary supplement | Placebo capsules, obese, Placebo, normal weight |
| 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. | Dietary supplement | Green tea, normal weight, Green tea, overweight |
Primary outcome
Faeces are collected for analyzing the gut flora and fat absorption
Time frame: At three time points (baseline, 6 weeks and 12 weeks)
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.
5 secondary outcomes
Resting energy expenditure (REE)
Time frame: At three time points (baseline, 6 weeks and 12 weeks)
Respiratory quotient (RQ)
Time frame: At three time points (baseline, 6 weeks and 12 weeks)
Three frequency eating questionnaire (TFEQ)
Time frame: At three time points (baseline, 6 weeks and 12 weeks)
Body composition: BMI, body fat percentage, fat mass index (FMI)
Time frame: At three time points (baseline, 6 weeks and 12 weeks)
Body fat distribution: waist circumference, waist-to-hip ratio (WHR
Time frame: At three time points (baseline, 6 weeks and 12 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2016.
- Background: PubMed 21366839Hursel 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.
- Background: PubMed 19597519Hursel 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.
- Derived from this study: PubMed 27054321Janssens 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.
- Derived from this study: PubMed 25740906Janssens 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margriet Westerterp-Plantenga, Prof. Dr. principal investigator
Maastricht University, department of human biology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing green tea (757 mg/capsule [84.5 mg EGCG + 2.1 mg caffeine ] in people with Obesity, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Faeces are collected for analyzing the gut flora and fat absorption (time frame: At three time points (baseline, 6 weeks and 12 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01556321, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2016.