Resveratrol and Serum Apo A-I

Dyslipidemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01364961
• Other study ID #: MEC 10-3-054
• Status: Completed
• Phase: N/A
• First received: January 17, 2011
• Last updated: November 12, 2013
• Start date: January 2011
• Est. completion date: August 2013

Study information

• Verified date: November 2013
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

Dietary Supplement:
• Resveratrol capsules
2 x 75 mg resveratrol each day, for 4 weeks

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	DSM Nutritional Products, Inc.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ApoA-I level		Measured at baseline, after 4 weeks, 8 weeks and 12 weeks	No
Secondary	Endothelial function and arterial stiffness		Measured in weeks 4 and 12	No
Secondary	Endothelial function of the retinal microvasculature		Measured in weeks 4 and 12	No
Secondary	Lipid and glucose metabolism during the fasting and postprandial phase		Measured at baseline, after 4 weeks, 8 weeks and 12 weeks	No
Secondary	biomarkers for low-grade systemic inflammation and endothelial function		Measured at baseline, after 4 weeks, 8 weeks and 12 weeks	No