NCT00867555

Brief Summary

The body of evidence regarding the health benefits of green tea has grown considerably during the last decade and includes antioxidant properties, anti- cancer, anti-obesity and anti-diabetes effects. There has been evidence that green tea extract favorably affect body weight and body fat and has positive effects on blood glucose control Aim of this study is to investigate the short term effect (3-day)of TEAVIGO (high in the catechin EGCG) on postprandial fat oxidation during different phases of the postprandial period in overweight subjects. Secondly, in a subset of volunteers changes in lipolysis and glucose metabolism will be studied in skeletal muscle and adipose tissue.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Oct 2008

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 24, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

September 18, 2009

Status Verified

September 1, 2009

Enrollment Period

7 months

First QC Date

March 23, 2009

Last Update Submit

September 17, 2009

Conditions

Outcome Measures

Primary Outcomes (1)

  • postprandial fat oxidation

    8 months

Study Arms (2)

EGCG

EXPERIMENTAL

Double blind randomized, placebo-controlled cross-over design with two arms: * the green tea extract TEAVIGO, high in EGCG and * placebo

Dietary Supplement: Effect of the green tea extract TEAVIGO, high in EGCG, on postprandial fat oxidation

placebo

PLACEBO COMPARATOR
Dietary Supplement: Effect of the green tea extract TEAVIGO, high in EGCG, on postprandial fat oxidation

Interventions

green tea extract TEAVIGO, high in EGCG

EGCGplacebo

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 20 and 50 y
  • BMI 25.0-29.9 kg/m2
  • Normal fasting glucose \<6.1 mmol/L
  • Blood pressure (systolic blood pressure 100-150 mmHg, diastolic blood pressure 60-90 mmHg)
  • Weight stable in last 3 months (±2 kg)

You may not qualify if:

  • pregnant, lactating or (post)menopausal women
  • regular smokers
  • people with intensive fitness training eg athletes
  • habitual consumption of green or black tea (more than 1 or 2 cups a day, respectively)
  • not more than 300 mg/day caffeine consumption

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept Human Biology, Maastricht University

Maastricht, 6200 MD, Netherlands

Location

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2

Interventions

epigallocatechin gallate

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Study Officials

  • Ellen E Blaak, PhD, Prof

    Maastricht University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 23, 2009

First Posted

March 24, 2009

Study Start

October 1, 2008

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

September 18, 2009

Record last verified: 2009-09

Locations