The effects of resveratrol on serum apolipoprotein A-I concentrations in men and women with low HDL-cholesterol concentrations.

Completed

• Conditions: a low concentration of the protective ('good') cholesterol; Low HDL cholesterol; 10013317

• Registration Number: NL-OMON38326
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

• aged between 45 and 70 years
• HDL-C <1.21 mmol/L (men)
• HDL-C <1.53 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:
o grapes
o wine (red and white)
o all berries
o peanuts
o peanut butter
o soy (products)
o 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. Oral anti-contraceptives and paracetamol are allowed.
• 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: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the change in serum apoA-I concentrations and serum<br /><br>HDL-C.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-flow-mediated dilation<br /><br>-pulse wave velocity<br /><br>-glucose- en insulineconcentration<br /><br>-ApoB<br /><br>-Total cholesterol<br /><br>-LDL-C<br /><br>-Triglycerides<br /><br>-hdCRP<br /><br>-IL-6<br /><br>-sICAM-1<br /><br>-VCAM-1<br /><br>-MCP-1<br /><br>-sE Selectin<br /><br>- Blood chemistry: phosphorus, sodium, potassium, chloride, calcium,<br /><br>creatinine, blood urea nitrogen (BUN), protein, albumin, gammaGT,<br /><br>aspartate-aminotransferase (AST), alanine-aminotransferase (ALT), alkaline<br /><br>phosphatase (ALP), bilirubin<br /><br>- Haematology: White cell count, red cell count, platelet count, hemoglobin,<br /><br>hematocrit, mean cell volume, and mean cell hemoglobin concentration, red cell<br /><br>distribution<br /><br>- Blood coagulation: Prothrombin time (PT) and aPT</p><br>