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Green Tea, High in Epigallocatechin Gallate (EGCG) and Postprandial Fat Oxidation

Primary Purpose

Obesity, Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Effect of the green tea extract TEAVIGO, high in EGCG, on postprandial fat oxidation
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Sites / Locations

  • Dept Human Biology, Maastricht University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

EGCG

placebo

Arm Description

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

Outcomes

Primary Outcome Measures

postprandial fat oxidation

Secondary Outcome Measures

Full Information

First Posted
March 23, 2009
Last Updated
September 17, 2009
Sponsor
Maastricht University Medical Center
Collaborators
DSM Nutritional Products, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00867555
Brief Title
Green Tea, High in Epigallocatechin Gallate (EGCG) and Postprandial Fat Oxidation
Official Title
Effects of the Green Tea Extract TEAVIGO High in EGCG, on Postprandial Fat Oxidation in Overweight Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Maastricht University Medical Center
Collaborators
DSM Nutritional Products, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EGCG
Arm Type
Experimental
Arm Description
Double blind randomized, placebo-controlled cross-over design with two arms: the green tea extract TEAVIGO, high in EGCG and placebo
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Effect of the green tea extract TEAVIGO, high in EGCG, on postprandial fat oxidation
Intervention Description
green tea extract TEAVIGO, high in EGCG
Primary Outcome Measure Information:
Title
postprandial fat oxidation
Time Frame
8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen E Blaak, PhD, Prof
Organizational Affiliation
Maastricht University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept Human Biology, Maastricht University
City
Maastricht
ZIP/Postal Code
6200 MD
Country
Netherlands

12. IPD Sharing Statement

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Green Tea, High in Epigallocatechin Gallate (EGCG) and Postprandial Fat Oxidation

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