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

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ClinicalTrials.gov Identifier: NCT00867555
Recruitment Status : Completed
First Posted : March 24, 2009
Last Update Posted : September 18, 2009
Sponsor:
Collaborator:
DSM Nutritional Products, Inc.
Information provided by:
Maastricht University Medical Center

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.


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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Effects of the Green Tea Extract TEAVIGO High in EGCG, on Postprandial Fat Oxidation in Overweight Volunteers
Study Start Date : October 2008
Primary Completion Date : May 2009
Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. postprandial fat oxidation [ Time Frame: 8 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Ellen E Blaak, Prof, Maastricht University
ClinicalTrials.gov Identifier: NCT00867555     History of Changes
Other Study ID Numbers: MEC 08-3-052
First Posted: March 24, 2009    Key Record Dates
Last Update Posted: September 18, 2009
Last Verified: September 2009

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