Dietary Polyphenols and Lipid Oxidation

This study is currently recruiting participants.

Verified October 2012 by Maastricht University Medical Center

Sponsor:

Collaborator:

Alpro Foundation

Information provided by (Responsible Party):

Maastricht University Medical Center

ClinicalTrials.gov Identifier:

NCT01302639

First received: February 22, 2011

Last updated: October 24, 2012

Last verified: October 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	February 22, 2011
Last Updated Date	October 24, 2012
Start Date ^ICMJE	February 2011
Estimated Primary Completion Date	October 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 22, 2011)	postprandial fat oxidation [ Time Frame: 3 days ] [ Designated as safety issue: No ] 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
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01302639 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Dietary Polyphenols and Lipid Oxidation
Official Title ^ICMJE	Dietary Polyphenols as Modulators of Lipid Oxidation and Mitochondrial Function in Overweight Volunteers
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 objectives will be addressed in the current study: 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 to perform a randomized controlled dietary intervention study with the most promising combination of dietary polyphenols, investigating its effect on fat oxidation, mitochondrial function and insulin sensitivity in overweight subjects over a 12 wk period.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science
Condition ^ICMJE	Obesity, Insulin Sensitivity, Type 2 Diabetes Mellitus
Intervention ^ICMJE	Dietary Supplement: Comparison of different combinations of polyphenols with respect to effects on fat oxidation EGCG, resveratol and genistein
Study Arm (s)	Experimental: EGCG and resveratrol Intervention: Dietary Supplement: Comparison of different combinations of polyphenols with respect to effects on fat oxidation Experimental: EGCG, resveratrol and genistein Intervention: Dietary Supplement: Comparison of different combinations of polyphenols with respect to effects on fat oxidation Placebo Comparator: placebo Intervention: Dietary Supplement: Comparison of different combinations of polyphenols with respect to effects on fat oxidation
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	18
Estimated Completion Date	November 2013
Estimated Primary Completion Date	October 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	30 Years to 70 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Netherlands

Administrative Information
NCT Number ^ICMJE	NCT01302639
Other Study ID Numbers ^ICMJE	MEC 10-03-032.7
Has Data Monitoring Committee	No
Responsible Party	Maastricht University Medical Center
Study Sponsor ^ICMJE	Maastricht University Medical Center
Collaborators ^ICMJE	Alpro Foundation
Investigators ^ICMJE	Not Provided
Information Provided By	Maastricht University Medical Center
Verification Date	October 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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