NCT01556321

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jun 2012

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 16, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

March 18, 2016

Status Verified

May 1, 2013

Enrollment Period

2.5 years

First QC Date

March 7, 2012

Last Update Submit

March 17, 2016

Conditions

Obesity

Keywords

ObesityBody weightGut floraFat absorption

Outcome Measures

Primary Outcomes (1)

  • 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.

    At three time points (baseline, 6 weeks and 12 weeks)

Secondary Outcomes (5)

  • Resting energy expenditure (REE)

    At three time points (baseline, 6 weeks and 12 weeks)

  • Respiratory quotient (RQ)

    At three time points (baseline, 6 weeks and 12 weeks)

  • Three frequency eating questionnaire (TFEQ)

    At three time points (baseline, 6 weeks and 12 weeks)

  • Body composition: BMI, body fat percentage, fat mass index (FMI)

    At three time points (baseline, 6 weeks and 12 weeks)

  • Body fat distribution: waist circumference, waist-to-hip ratio (WHR

    At three time points (baseline, 6 weeks and 12 weeks)

Study Arms (4)

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

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

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

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

Dietary Supplement: placebo

Interventions

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.

Placebo capsules, obesePlacebo, normal weight
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.

Green tea, normal weightGreen tea, overweight

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University, Human Biology

Maastricht, 6229 ER, Netherlands

Location

Related Publications (4)

  • 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.

    PMID: 21366839BACKGROUND

  • 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.

    PMID: 19597519BACKGROUND

  • 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.

    PMID: 27054321DERIVED

  • 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.

    PMID: 25740906DERIVED

MeSH Terms

Conditions

ObesityBody Weight

Interventions

TeaCaffeine

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesXanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Margriet Westerterp-Plantenga, Prof. Dr.

    Maastricht University, department of human biology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2012

First Posted

March 16, 2012

Study Start

June 1, 2012

Primary Completion

December 1, 2014

Study Completion

April 1, 2015

Last Updated

March 18, 2016

Record last verified: 2013-05

Locations

NL(1)