Dietary Polyphenols and Lipid Oxidation

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 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: September 3, 2013
Last verified: September 2013
  Purpose

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


Condition Intervention
Obesity, Insulin Sensitivity, Type 2 Diabetes Mellitus
Dietary Supplement: Comparison of different combinations of polyphenols with respect to effects on fat oxidation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Dietary Polyphenols as Modulators of Lipid Oxidation and Mitochondrial Function in Overweight Volunteers

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • 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



Estimated Enrollment: 18
Study Start Date: February 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EGCG and resveratrol Dietary Supplement: Comparison of different combinations of polyphenols with respect to effects on fat oxidation
EGCG, resveratol and genistein
Experimental: EGCG, resveratrol and genistein Dietary Supplement: Comparison of different combinations of polyphenols with respect to effects on fat oxidation
EGCG, resveratol and genistein
Placebo Comparator: placebo Dietary Supplement: Comparison of different combinations of polyphenols with respect to effects on fat oxidation
EGCG, resveratol and genistein

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01302639

Locations
Netherlands
Maastricht University Recruiting
Maastricht, Netherlands, 6200 MD
Contact: JAsper Most, Bsc    +31433881621    J.most@maastrichtuniversity.nl   
Principal Investigator: Ellen E Blaak, Prof         
Sponsors and Collaborators
Maastricht University Medical Center
Alpro Foundation
  More Information

No publications provided by Maastricht University Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01302639     History of Changes
Other Study ID Numbers: MEC 10-03-032.7
Study First Received: February 22, 2011
Last Updated: September 3, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Hyperinsulinism

ClinicalTrials.gov processed this record on July 31, 2014