Dyslipidemia
Conditions
Keywords
Resveratrol, FMD, PWV, HDL-cholesterol, Macrovasculature, Microvasculature
Brief summary
Although much effort has been done to lower LDL-cholesterol concentrations, there is still a substantial risk for cardiovascular disease (CVD). Another strategy to lower the risk for CVD is elevating the HDL-cholesterol (HDL-C). Both in vitro and in vivo studies showed that elevating HDL-C or apolipoprotein A-I (Apo A-I) levels protect against CVD. However, despite many initiatives, no new widely applicable intervention strategies with proven efficacy have been developed. Epidemiologic studies have shown that a higher polyphenol intake is associated with a lower risk for CVD. Resveratrol, a polyphenol, could, through several beneficial mechanisms, exert a positive effect on formation of atherosclerotic plaques and thus on developing CVD. It has been shown in animals that resveratrol elevates PPAR-alpha activity. This may lead to elevated apo A-I and HDL-C levels in the blood. However, these effects are not shown in human intervention studies.
Interventions
DIETARY_SUPPLEMENTResveratrol capsules
2 x 75 mg resveratrol each day, for 4 weeks
Sponsors
DSM Nutritional Products, Inc.
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* aged between 45 and 70 years * HDL-C \<1.0 mmol/L (men) * HDL-C \<1.3 mmol/L (women) * serum total cholesterol \<8.0 mmol/L * plasma glucose \<7.0 mmol/L * BMI between 25 - 35 kg/m2 * non-smoking * willingness to abstain from resveratrol rich products from two weeks prior to the study and the duration of the study: * grapes and grape juice * wine (red and white) * all berries * peanuts * peanut butter * soy (products) * pomegranate
Exclusion criteria
* unstable body weight (weight gain or loss \>3 kg in the past 3 months) * indication for treatment with cholesterol-lowering drugs according to the Dutch Cholesterol Consensus * use of medication or a medically-prescribed diet known to affect serum lipid or glucose metabolism * Active cardiovascular disease (for instance congestive heart failure) or recent (\<6 months) event, such as acute myocardial infarction or cerebro-vascular accident * not willing to stop the consumption of vitamin supplements, fish oil capsules or products rich in plant stanol or sterol esters 3 weeks before the start of the study * men: consumption of \>21 glasses of alcohol-containing drinks per week women: consumption of \>14 glasses of alcohol-containing drinks per week * abuse of drugs * pregnant or breastfeeding women * participation in another biomedical study within 1 month prior to the screening visit * having donated blood (as blood donor) within 1 month prior to the screening visit or planning to do so during the study * impossible or difficult to puncture as evidenced during the screening visits
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ApoA-I level | Measured at baseline, after 4 weeks, 8 weeks and 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Endothelial function and arterial stiffness | Measured in weeks 4 and 12 |
| Endothelial function of the retinal microvasculature | Measured in weeks 4 and 12 |
| Lipid and glucose metabolism during the fasting and postprandial phase | Measured at baseline, after 4 weeks, 8 weeks and 12 weeks |
| biomarkers for low-grade systemic inflammation and endothelial function | Measured at baseline, after 4 weeks, 8 weeks and 12 weeks |
Countries
Netherlands
Outcome results
None listed