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OpenTrials
Completed

NCT Number: NCT01302639

Dietary Polyphenols and Lipid Oxidation

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

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Comparison of different combinations of polyphenols with respect to effects on fat oxidation

Dietary Supplement

EGCG, resveratol and genistein

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Alpro Foundation

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 24, 2011
Registry last updated
Sep 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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