Ignite Creation Date:
2025-12-24 @ 11:50 AM
Ignite Modification Date:
2025-12-26 @ 7:23 AM
Study NCT ID:
NCT01364961
Status:
COMPLETED
Last Update Posted:
2013-11-13
First Post:
2011-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Resveratrol and Serum Apo A-I
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077185', 'term': 'Resveratrol'}], 'ancestors': [{'id': 'D000081225', 'term': 'Stilbestrols'}, {'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D059808', 'term': 'Polyphenols'}, {'id': 'D010636', 'term': 'Phenols'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-12', 'studyFirstSubmitDate': '2011-01-17', 'studyFirstSubmitQcDate': '2011-06-01', 'lastUpdatePostDateStruct': {'date': '2013-11-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ApoA-I level', 'timeFrame': 'Measured at baseline, after 4 weeks, 8 weeks and 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Endothelial function and arterial stiffness', 'timeFrame': 'Measured in weeks 4 and 12'}, {'measure': 'Endothelial function of the retinal microvasculature', 'timeFrame': 'Measured in weeks 4 and 12'}, {'measure': 'Lipid and glucose metabolism during the fasting and postprandial phase', 'timeFrame': 'Measured at baseline, after 4 weeks, 8 weeks and 12 weeks'}, {'measure': 'biomarkers for low-grade systemic inflammation and endothelial function', 'timeFrame': 'Measured at baseline, after 4 weeks, 8 weeks and 12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Resveratrol', 'FMD', 'PWV', 'HDL-cholesterol', 'Macrovasculature', 'Microvasculature'], 'conditions': ['Dyslipidemia']}, 'referencesModule': {'references': [{'pmid': '25790328', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nEpidemiologic 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged between 45 and 70 years\n* HDL-C \\<1.0 mmol/L (men)\n* HDL-C \\<1.3 mmol/L (women)\n* serum total cholesterol \\<8.0 mmol/L\n* plasma glucose \\<7.0 mmol/L\n* BMI between 25 - 35 kg/m2\n* non-smoking\n* willingness to abstain from resveratrol rich products from two weeks prior to the study and the duration of the study:\n\n * grapes and grape juice\n * wine (red and white)\n * all berries\n * peanuts\n * peanut butter\n * soy (products)\n * pomegranate\n\nExclusion Criteria:\n\n* unstable body weight (weight gain or loss \\>3 kg in the past 3 months)\n* indication for treatment with cholesterol-lowering drugs according to the Dutch Cholesterol Consensus\n* use of medication or a medically-prescribed diet known to affect serum lipid or glucose metabolism\n* Active cardiovascular disease (for instance congestive heart failure) or recent (\\<6 months) event, such as acute myocardial infarction or cerebro-vascular accident\n* 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\n* men: consumption of \\>21 glasses of alcohol-containing drinks per week women: consumption of \\>14 glasses of alcohol-containing drinks per week\n* abuse of drugs\n* pregnant or breastfeeding women\n* participation in another biomedical study within 1 month prior to the screening visit\n* having donated blood (as blood donor) within 1 month prior to the screening visit or planning to do so during the study\n* impossible or difficult to puncture as evidenced during the screening visits'}, 'identificationModule': {'nctId': 'NCT01364961', 'briefTitle': 'Resveratrol and Serum Apo A-I', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'The Effects of Resveratrol on Serum Apolipoprotein A-I Concentrations in Men and Women With Low HDL-cholesterol Concentrations', 'orgStudyIdInfo': {'id': 'MEC 10-3-054'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Cellulose capsules', 'interventionNames': ['Dietary Supplement: Resveratrol capsules']}, {'type': 'EXPERIMENTAL', 'label': 'Resveratrol capsules', 'interventionNames': ['Dietary Supplement: Resveratrol capsules']}], 'interventions': [{'name': 'Resveratrol capsules', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Resveratrol will be provided as resVida®'], 'description': '2 x 75 mg resveratrol each day, for 4 weeks', 'armGroupLabels': ['Cellulose capsules', 'Resveratrol capsules']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Maastricht University Medical Center', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'Ronald P Mensink, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'DSM Nutritional Products, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}