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Resveratrol and Serum Apo A-I

This study has been completed.
DSM Nutritional Products, Inc.
Information provided by (Responsible Party):
Maastricht University Medical Center Identifier:
First received: January 17, 2011
Last updated: November 12, 2013
Last verified: November 2013

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.

Condition Intervention
Dietary Supplement: Resveratrol capsules

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effects of Resveratrol on Serum Apolipoprotein A-I Concentrations in Men and Women With Low HDL-cholesterol Concentrations

Resource links provided by NLM:

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • ApoA-I level [ Time Frame: Measured at baseline, after 4 weeks, 8 weeks and 12 weeks ]

Secondary Outcome Measures:
  • Endothelial function and arterial stiffness [ Time Frame: Measured in weeks 4 and 12 ]
  • Endothelial function of the retinal microvasculature [ Time Frame: Measured in weeks 4 and 12 ]
  • Lipid and glucose metabolism during the fasting and postprandial phase [ Time Frame: Measured at baseline, after 4 weeks, 8 weeks and 12 weeks ]
  • biomarkers for low-grade systemic inflammation and endothelial function [ Time Frame: Measured at baseline, after 4 weeks, 8 weeks and 12 weeks ]

Enrollment: 50
Study Start Date: January 2011
Study Completion Date: August 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Cellulose capsules Dietary Supplement: Resveratrol capsules
2 x 75 mg resveratrol each day, for 4 weeks
Other Name: Resveratrol will be provided as resVida®
Experimental: Resveratrol capsules Dietary Supplement: Resveratrol capsules
2 x 75 mg resveratrol each day, for 4 weeks
Other Name: Resveratrol will be provided as resVida®


Ages Eligible for Study:   45 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01364961

Maastricht University Medical Center
Maastricht, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
DSM Nutritional Products, Inc.
Principal Investigator: Ronald P Mensink, PhD Maastricht University Medical Center
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Maastricht University Medical Center Identifier: NCT01364961     History of Changes
Other Study ID Numbers: MEC 10-3-054
Study First Received: January 17, 2011
Last Updated: November 12, 2013

Keywords provided by Maastricht University Medical Center:

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Antimutagenic Agents
Anticarcinogenic Agents processed this record on May 25, 2017