Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 11:39 PM
Study NCT ID:
NCT00954434
Status:
COMPLETED
Last Update Posted:
2016-05-17
First Post:
2009-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Red Wine on Cardiovascular Risk Factors in Humans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-16', 'studyFirstSubmitDate': '2009-08-06', 'studyFirstSubmitQcDate': '2009-08-06', 'lastUpdatePostDateStruct': {'date': '2016-05-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'effects on laboratory variables, mood and body composition', 'timeFrame': '3 months', 'description': 'changes in mood, blood lipids, insulin levels, markers of inflammation and effects on liver and body composition.'}], 'secondaryOutcomes': [{'measure': 'effects on liver fat amount', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'Fifty healthy human subjects are randomized to not to consume any alcohol at all or to drink 1 glass of red wine/day for women or 2 glasses for men for three months. Outcomes are changes in mood, blood lipids, insulin levels, markers of inflammation and effects on liver and body composition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy subjects\n* 25 years of age and older\n\nExclusion Criteria:\n\n* alcoholic first degree relatives'}, 'identificationModule': {'nctId': 'NCT00954434', 'briefTitle': 'Effects of Red Wine on Cardiovascular Risk Factors in Humans', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Linkoeping'}, 'orgStudyIdInfo': {'id': 'M246-08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'red wine', 'description': 'intervention: dietary supplement intake of red wine on a daily basis, 1 glass/day for women, 2 for men', 'interventionNames': ['Dietary Supplement: red wine']}, {'type': 'NO_INTERVENTION', 'label': 'total abstention from alcohol'}], 'interventions': [{'name': 'red wine', 'type': 'DIETARY_SUPPLEMENT', 'description': 'intake of red wine on a daily basis', 'armGroupLabels': ['red wine']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Fredrik H Nystrom, MD PhD prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Linkoping, Sweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Linkoeping', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Fredrik H Nystrom MD, professor', 'oldOrganization': 'University Hospital, Linkoeping, Sweden'}}}}