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Resveratrol and Serum Apo A-I

This study is currently recruiting participants.
Verified June 2011 by Maastricht University Medical Center
Sponsor:
Collaborator:
DSM Nutritional Products, Inc.
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01364961
First received: January 17, 2011
Last updated: June 17, 2011
Last verified: June 2011
History of Changes
  Purpose

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
Dyslipidemia
 Dietary Supplement: Resveratrol capsules

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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:

MedlinePlus related topics: Cholesterol
Drug Information available for: Resveratrol
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    Changes will be calculated between day 25+28 and day 0 of each experimental period.


Secondary Outcome Measures:
  • Endothelial function and arterial stiffness [ Time Frame: Measured in weeks 4 and 12 ] [ Designated as safety issue: No ]
  • Endothelial function of the retinal microvasculature [ Time Frame: Measured in weeks 4 and 12 ] [ Designated as safety issue: No ]
  • Lipid and glucose metabolism during the fasting and postprandial phase [ Time Frame: Measured at baseline, after 4 weeks, 8 weeks and 12 weeks ] [ Designated as safety issue: No ]
    Changes will be calculated between day 25+28 and day 0 of each experimental period.

  • biomarkers for low-grade systemic inflammation and endothelial function [ Time Frame: Measured at baseline, after 4 weeks, 8 weeks and 12 weeks ] [ Designated as safety issue: No ]
    Changes will be calculated between day 25+28 and day 0 of each experimental period


Estimated Enrollment: 50
Study Start Date: January 2011
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: November 2011 (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®

  Eligibility

Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01364961

Contacts
Contact: Sanne M van der Made, M.Sc. +31433882113 sanne.vandermade@maastrichtuniversity.nl

Locations
Netherlands
Maastricht University Medical Center Recruiting
Maastricht, Netherlands
Contact: S. M. van der Made, M.Sc.     +31 (0)43 3882113     sanne.vandermade@maastrichtuniversity.nl    
Sponsors and Collaborators
Maastricht University Medical Center
DSM Nutritional Products, Inc.
Investigators
Principal Investigator: Ronald P Mensink, PhD Maastricht University Medical Center
  More Information

No publications provided

Responsible Party: R.P. Mensink, PhD, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01364961     History of Changes
Other Study ID Numbers: MEC 10-3-054
Study First Received: January 17, 2011
Last Updated: June 17, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Resveratrol
FMD
PWV
 HDL-cholesterol
Macrovasculature
Microvasculature

Additional relevant MeSH terms:
Resveratrol
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
 Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Hematologic Agents
Antimutagenic Agents
Anticarcinogenic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013