Resveratrol and Serum Apo A-I

Study Overview
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Brief Summary
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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.

Official Title
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The Effects of Resveratrol on Serum Apolipoprotein A-I Concentrations in Men and Women With Low HDL-cholesterol Concentrations

Conditions
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Dyslipidemia

Intervention / Treatment
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* Dietary Supplement: Resveratrol capsules


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Cellulose capsules<br> | Dietary Supplement: Resveratrol capsules<br>* 2 x 75 mg resveratrol each day, for 4 weeks<br>* Other names: Resveratrol will be provided as resVida®;|
| Experimental: Resveratrol capsules<br> | Dietary Supplement: Resveratrol capsules<br>* 2 x 75 mg resveratrol each day, for 4 weeks<br>* Other names: Resveratrol will be provided as resVida®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ApoA-I level |  | Measured at baseline, after 4 weeks, 8 weeks and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Resveratrol, FMD, PWV, HDL-cholesterol, Macrovasculature, Microvasculature