Green Tea, High in Epigallocatechin Gallate (EGCG) and Postprandial Fat Oxidation
Effects of the Green Tea Extract TEAVIGO High in EGCG, on Postprandial Fat Oxidation in Overweight Volunteers
1 other identifier
interventional
24
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Oct 2008
Shorter than P25 for not_applicable obesity
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
March 23, 2009
CompletedFirst Posted
Study publicly available on registry
March 24, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedSeptember 18, 2009
September 1, 2009
7 months
March 23, 2009
September 17, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
postprandial fat oxidation
8 months
Study Arms (2)
EGCG
EXPERIMENTALDouble blind randomized, placebo-controlled cross-over design with two arms: * the green tea extract TEAVIGO, high in EGCG and * placebo
placebo
PLACEBO COMPARATORInterventions
green tea extract TEAVIGO, high in EGCG
Eligibility Criteria
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ellen E Blaak, PhD, Prof
Maastricht University
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