Dietary Polyphenols and Lipid Oxidation
Dietary Polyphenols as Modulators of Lipid Oxidation and Mitochondrial Function in Overweight Volunteers
1 other identifier
interventional
18
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 22, 2011
CompletedFirst Posted
Study publicly available on registry
February 24, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedSeptember 9, 2014
September 1, 2014
2.7 years
February 22, 2011
September 8, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
postprandial fat oxidation
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
Study Arms (3)
EGCG and resveratrol
EXPERIMENTALEGCG, resveratrol and genistein
EXPERIMENTALplacebo
PLACEBO COMPARATORInterventions
EGCG, resveratol and genistein
Eligibility Criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Maastricht University Medical Centerlead
- Alpro Foundationcollaborator
Study Sites (1)
Maastricht University
Maastricht, 6200 MD, Netherlands
Related Publications (1)
Most J, Goossens GH, Jocken JW, Blaak EE. Short-term supplementation with a specific combination of dietary polyphenols increases energy expenditure and alters substrate metabolism in overweight subjects. Int J Obes (Lond). 2014 May;38(5):698-706. doi: 10.1038/ijo.2013.231. Epub 2013 Dec 9.
PMID: 24317366DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2011
First Posted
February 24, 2011
Study Start
February 1, 2011
Primary Completion
October 1, 2013
Study Completion
November 1, 2013
Last Updated
September 9, 2014
Record last verified: 2014-09