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Resveratrol and Serum Apo A-I

Primary Purpose

Dyslipidemia

Status

Completed

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Resveratrol capsules

About this trial

This is an interventional basic science trial for Dyslipidemia focused on measuring Resveratrol, FMD, PWV, HDL-cholesterol, Macrovasculature, Microvasculature

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Maastricht University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Cellulose capsules

Resveratrol capsules

Arm Description

Outcomes

Primary Outcome Measures

ApoA-I level

Secondary Outcome Measures

Endothelial function and arterial stiffness

Endothelial function of the retinal microvasculature

Lipid and glucose metabolism during the fasting and postprandial phase

biomarkers for low-grade systemic inflammation and endothelial function

Full Information

NCT ID

NCT01364961

First Posted

January 17, 2011

Last Updated

November 12, 2013

Sponsor

Maastricht University Medical Center

Collaborators

DSM Nutritional Products, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01364961

Brief Title

Resveratrol and Serum Apo A-I

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Maastricht University Medical Center

Collaborators

DSM Nutritional Products, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dyslipidemia

Keywords

Resveratrol, FMD, PWV, HDL-cholesterol, Macrovasculature, Microvasculature

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cellulose capsules

Arm Type

Placebo Comparator

Arm Title

Resveratrol capsules

Arm Type

Experimental

Intervention Type

Dietary Supplement

Intervention Name(s)

Resveratrol capsules

Other Intervention Name(s)

Resveratrol will be provided as resVida®

Intervention Description

2 x 75 mg resveratrol each day, for 4 weeks

Primary Outcome Measure Information:

Title

ApoA-I level

Time Frame

Measured at baseline, after 4 weeks, 8 weeks and 12 weeks

Secondary Outcome Measure Information:

Title

Endothelial function and arterial stiffness

Time Frame

Measured in weeks 4 and 12

Title

Endothelial function of the retinal microvasculature

Time Frame

Measured in weeks 4 and 12

Title

Lipid and glucose metabolism during the fasting and postprandial phase

Time Frame

Measured at baseline, after 4 weeks, 8 weeks and 12 weeks

Title

biomarkers for low-grade systemic inflammation and endothelial function

Time Frame

Measured at baseline, after 4 weeks, 8 weeks and 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ronald P Mensink, PhD

Organizational Affiliation

Maastricht University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Maastricht University Medical Center

City

Maastricht

Country

Netherlands

12. IPD Sharing Statement

Citations:

PubMed Identifier

25790328

Citation

van der Made SM, Plat J, Mensink RP. Resveratrol does not influence metabolic risk markers related to cardiovascular health in overweight and slightly obese subjects: a randomized, placebo-controlled crossover trial. PLoS One. 2015 Mar 19;10(3):e0118393. doi: 10.1371/journal.pone.0118393. eCollection 2015.

Results Reference

derived

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Resveratrol and Serum Apo A-I

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