Dietary Polyphenols and Lipid Oxidation

September 8, 2014 updated by: Maastricht University Medical Center

Dietary Polyphenols as Modulators of Lipid Oxidation and Mitochondrial Function in Overweight Volunteers

There are strong indications that (combinations of) polyphenols may be attractive candidates in the prevention of the metabolic syndrome and diabetes through modulation of pathways of fatty acid metabolism and mitochondrial function. We hypothesize that the combination of specific polyphenols, with partly distinct mechanisms of action, may have physiologically significant effects on fat oxidation through additive or synergistic effects, thereby improving body composition, insulin sensitivity and preventing type 2 diabetes. The following objective will be addressed in the current study:

(1) to test short term (3 day) effects of combinations of polyphenols (supplements of EGCG either in combination with resveratrol or with resveratrol and genistein) to affect systemic lipolysis and fat oxidation during overnight fasted conditions and after ingestion of a high fat meal in overweight subjects

Study Overview

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Maastricht, Netherlands, 6200 MD
        • Maastricht University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • overweight men and women (BMI≥25kg/m2- 29.9 kg/m2), aged 30-70 years, Caucasian, normal fasting glucose (< 6.1 mmol/L) and blood pressure (systolic blood pressure 100-140 mmHg, diastolic blood pressure 60-90 mmHg), weight stable in last 3 months (± 2kg). Exclusion criteria:

Exclusion Criteria:

  • women lactating, pregnant or (post)menopausal, regular smokers, people with intensive fitness training, eg. athletes (≥ 3 per week ≥ 1 hour training), habitual consumption of green tea (more than 1 cup per day) or products containing green tea extract, total caffeine consumption > 300 mg/day, alcohol intake >20 g/day, any dietary vitamins or dietary supplements, diabetes mellitus (defined as FPG ≥ 7.0 mmol/l and/or 2hPG ≥ 11.1 mmol/l); serious pulmonary, cardiovascular, hepatic or renal disease : history of cardiovascular disease, all other relevant medical disorders that potentially interfere with this trial, current use of medication interfering with study intervention or interfering with study endpoints/hypotheses.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
EGCG, resveratol and genistein
Experimental: EGCG and resveratrol
EGCG, resveratol and genistein
Experimental: EGCG, resveratrol and genistein
EGCG, resveratol and genistein

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postprandial fat oxidation
Time Frame: 3 days

3 day supplementation of different combinations of polyphenols in a randomised crossover design in healthy overweight volunteers.

At the end of each supplementation period, postprandial fat oxidation is measured

3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

February 22, 2011

First Submitted That Met QC Criteria

February 22, 2011

First Posted (Estimate)

February 24, 2011

Study Record Updates

Last Update Posted (Estimate)

September 9, 2014

Last Update Submitted That Met QC Criteria

September 8, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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