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Green Tea, High in Epigallocatechin Gallate (EGCG) and Postprandial Fat Oxidation
This study is currently recruiting participants.
Verified by Maastricht University Medical Center, March 2009
First Received: March 23, 2009   No Changes Posted
Sponsors and Collaborators: Maastricht University Medical Center
DSM Nutritional Products, Inc.
Information provided by: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00867555
  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: Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study
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
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
green tea extract TEAVIGO, high in EGCG
placebo: Placebo Comparator 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00867555

Contacts
Contact: Judith Can, Drs +31433884256 J.vanCan@Hb.unimaas.nl

Locations
Netherlands
Dept Human Biology, Maastricht University Recruiting
Maastricht, Netherlands, 6200 MD
Contact: Judith Can, Bsc         J.vanCan@Hb.unimaas.nl    
Principal Investigator: Ellen E Blaak, PhD, Prof            
Sponsors and Collaborators
Maastricht University Medical Center
DSM Nutritional Products, Inc.
Investigators
Principal Investigator: Ellen E Blaak, PhD, Prof Maastricht University Medical Center
  More Information

No publications provided

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

Study placed in the following topic categories:
Anticarcinogenic Agents
Epigallocatechin gallate
Obesity
Antioxidants
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Overweight
Epigallocatechin
Neuroprotective Agents
Body Weight
Signs and Symptoms
Tea
Diabetes Mellitus, Type 2
Nutrition Disorders
Overnutrition
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

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

ClinicalTrials.gov processed this record on August 25, 2009