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Resveratrol and Serum Apo A-I

This study has been completed.
Sponsor:
Collaborator:
DSM Nutritional Products, Inc.
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01364961
First received: January 17, 2011
Last updated: November 12, 2013
Last verified: November 2013

January 17, 2011
November 12, 2013
January 2011
December 2012   (final data collection date for primary outcome measure)
ApoA-I level [ Time Frame: Measured at baseline, after 4 weeks, 8 weeks and 12 weeks ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT01364961 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • 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
Not Provided
Not Provided
 
Resveratrol and Serum Apo A-I
The Effects of Resveratrol on Serum Apolipoprotein A-I Concentrations in Men and Women With Low HDL-cholesterol Concentrations

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Dyslipidemia
Dietary Supplement: Resveratrol capsules
2 x 75 mg resveratrol each day, for 4 weeks
Other Name: Resveratrol will be provided as resVida®
  • Placebo Comparator: Cellulose capsules
    Intervention: Dietary Supplement: Resveratrol capsules
  • Experimental: Resveratrol capsules
    Intervention: Dietary Supplement: Resveratrol capsules
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
August 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
45 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01364961
MEC 10-3-054
No
Maastricht University Medical Center
Maastricht University Medical Center
DSM Nutritional Products, Inc.
Principal Investigator: Ronald P Mensink, PhD Maastricht University Medical Center
Maastricht University Medical Center
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP