Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-27 @ 11:44 PM
Study NCT ID:
NCT01244360
Status:
UNKNOWN
Last Update Posted:
2011-06-02
First Post:
2010-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Resveratrol Supplementation on Measurements of Health and Human Performance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose 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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-06-01', 'studyFirstSubmitDate': '2010-11-17', 'studyFirstSubmitQcDate': '2010-11-18', 'lastUpdatePostDateStruct': {'date': '2011-06-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vascular function', 'timeFrame': '4 weeks, with option of additional 4 week treatment period', 'description': 'vascular response to stress will be measured using flow mediated dilation and ultrasound.'}], 'secondaryOutcomes': [{'measure': 'Body fat percentage', 'timeFrame': '4 weeks, with optional additional 4 week treatment period', 'description': 'Body fat percentage will be measured using a DEXA scan.'}, {'measure': 'inflammation biomarkers', 'timeFrame': '4 weeks, with optional additional 4 week treatment period', 'description': 'Fasting blood draw'}, {'measure': 'cognitive function', 'timeFrame': '4 weeks, with optional additional 4 week treatment period', 'description': 'cognitive function will be assessed using a validated computer based assessment tool'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['resveratrol', 'insulin', 'inflammation', 'cognition', 'metabolism'], 'conditions': ['Inflammation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the effects of resveratrol on health and human performance. The study will evaluate cognitive function and several indicators of physical health before and after taking a resveratrol supplement or a placebo for three weeks.', 'detailedDescription': 'Measurements\n\n* blood laboratory parameters\n* cognitive assessment changes\n* body composition changes\n* vascular endothelial response'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* men and women between 45 and 75 years of age\n* Normal heart rate and Blood pressure\n* Ability to use personal computer interface\n* Successful completion of physical activity readiness questionnaire\n\nExclusion Criteria:\n\n* Cardiovascular disease, uncontrolled hypertension, lung disease\n* inability to tolerate exercise\n* have taken grape related supplement in past 12 months\n* current use of drugs or dietary supplements to enhance exercise performance\n* allergy to wine, grape juice or grape seed supplements'}, 'identificationModule': {'nctId': 'NCT01244360', 'acronym': 'MUresv', 'briefTitle': 'The Effects of Resveratrol Supplementation on Measurements of Health and Human Performance', 'organization': {'class': 'OTHER', 'fullName': 'Marywood University'}, 'officialTitle': 'The Effects of Resveratrol Supplementation on Measurements of Health and Human Performance', 'orgStudyIdInfo': {'id': 'MU Smoliga Resveratrol'}, 'secondaryIdInfos': [{'id': '2RESMU194218', 'type': 'OTHER', 'domain': 'Marywood University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Sugar Pill', 'description': 'Subject will take placebo for daily for 4 weeks, with optional additional 4 week treatment period.', 'interventionNames': ['Other: Placebo Comparator: Sugar Pill']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dietary Supplement: resveratrol', 'description': 'Subject will take resveratrol supplement for 4 weeks, with optional additional 4 week treatment period.', 'interventionNames': ['Dietary Supplement: resveratrol']}], 'interventions': [{'name': 'resveratrol', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Subject will take resveratrol supplement for 4 weeks, with optional additional 4 week treatment period.', 'armGroupLabels': ['Dietary Supplement: resveratrol']}, {'name': 'Placebo Comparator: Sugar Pill', 'type': 'OTHER', 'description': 'Subject will take placebo for daily for 4 weeks, with optional additional 4 week treatment period.', 'armGroupLabels': ['Sugar Pill']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18509', 'city': 'Scranton', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Marywood University', 'geoPoint': {'lat': 41.40916, 'lon': -75.6649}}], 'overallOfficials': [{'name': 'James Smoliga, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Marywood University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marywood University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'JAmes Smoliga, Ph.D.', 'oldOrganization': 'Marywood University'}}}}