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

Obesity Clinical Trial

Official title:

Effects of the Green Tea Extract TEAVIGO High in EGCG, on Postprandial Fat Oxidation in Overweight Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00867555
• Other study ID #: MEC 08-3-052
• Status: Completed
• Phase: N/A
• First received: March 23, 2009
• Last updated: September 17, 2009
• Start date: October 2008
• Est. completion date: May 2009

Study information

• Verified date: September 2009
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Obesity
• Type 2 Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
Netherlands	Dept Human Biology, Maastricht University	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	DSM Nutritional Products, Inc.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postprandial fat oxidation		8 months	No