Resveratrol and Serum Apo A-I
- Conditions
- Dyslipidemia
- Interventions
- Dietary Supplement: Resveratrol capsules
- Registration Number
- NCT01364961
- Lead Sponsor
- Maastricht University Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Cellulose capsules Resveratrol capsules - Resveratrol capsules Resveratrol capsules -
- Primary Outcome Measures
Name Time Method ApoA-I level Measured at baseline, after 4 weeks, 8 weeks and 12 weeks
- Secondary Outcome Measures
Name Time Method 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 Endothelial function of the retinal microvasculature Measured in weeks 4 and 12 Endothelial function and arterial stiffness Measured in weeks 4 and 12
Trial Locations
- Locations (1)
Maastricht University Medical Center
🇳🇱Maastricht, Netherlands