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

This study has been completed.
Sponsor:
Collaborator:
DSM Nutritional Products, Inc.
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00867555
First received: March 23, 2009
Last updated: September 17, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention
Obesity
Type 2 Diabetes Mellitus
Dietary Supplement: Effect of the green tea extract TEAVIGO, high in EGCG, on postprandial fat oxidation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Effects of the Green Tea Extract TEAVIGO High in EGCG, on Postprandial Fat Oxidation in Overweight Volunteers

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • postprandial fat oxidation [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: October 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EGCG

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

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00867555

Locations
Netherlands
Dept Human Biology, Maastricht University
Maastricht, Netherlands, 6200 MD
Sponsors and Collaborators
Maastricht University Medical Center
DSM Nutritional Products, Inc.
Investigators
Principal Investigator: Ellen E Blaak, PhD, Prof Maastricht University
  More Information

No publications provided

Responsible Party: Ellen E Blaak, Prof, Maastricht University
ClinicalTrials.gov Identifier: NCT00867555     History of Changes
Other Study ID Numbers: MEC 08-3-052
Study First Received: March 23, 2009
Last Updated: September 17, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Epigallocatechin gallate
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Antimutagenic Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses
Neuroprotective Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 22, 2014