Obesity, Insulin Sensitivity, Type 2 Diabetes Mellitus Clinical Trial
Official title:
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
| Status | Completed |
| Enrollment | 18 |
| Est. completion date | November 2013 |
| Est. primary completion date | October 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 30 Years to 70 Years |
| Eligibility |
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. |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | Maastricht University | Maastricht |
| Lead Sponsor | Collaborator |
|---|---|
| Maastricht University Medical Center | Alpro Foundation |
Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |