Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-31 @ 12:58 AM
Study NCT ID:
NCT01121003
Status:
COMPLETED
Last Update Posted:
2011-10-19
First Post:
2010-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Fructose and Exercise on Hepatic Lipid Metabolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-18', 'studyFirstSubmitDate': '2010-05-06', 'studyFirstSubmitQcDate': '2010-05-10', 'lastUpdatePostDateStruct': {'date': '2011-10-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hepatic de novo lipogenesis', 'timeFrame': 'after 4 days on controlled diet+exercise', 'description': 'Measurement of 13C VLDL palmitate after ingestion of 13C fructose'}], 'secondaryOutcomes': [{'measure': 'Plasma VLDL-triglyceride kinetics', 'timeFrame': 'after 4 days on controlled diet+exercise', 'description': 'Modelling of 2H5-glycerol incorporation in VLDL afetr administration of a bolus of 2H5 glycerol'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fructose', 'VLDL-triglycerides', 'de novo lipogenesis', 'Human metabolism'], 'conditions': ['Metabolism']}, 'descriptionModule': {'briefSummary': '8 healthy male volunteers will be studied each on 3 occasions, ie\n\n* after 4 days on a weight maintenance diet containing 5% simple sugars + low physical activity\n* after 4 days on a weight maintenance diet containing 30% fructose + low physical activity\n* after 4 days on a weight maintenance diet containing 30% fructose + high physical activity At the end of each of these 3 periods, fructose induced hepatic de novo lipogenesis (13C palmitate synthesis in response to ingestion of a 13C fructose load) and plasma VLDL-triglyceride kinetics (measured with a bolus of 2H-labeled glycerol) will be measured'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age between 18 and 30 years\n* males\n* BMI between 19 and 25\n* low to moderate physical activity (\\< 3 sessions/week)\n\nExclusion Criteria:\n\n* smoking\n* consumption of alcohol\\>50g/week\n* consumption of drugs or illicit substances\n* food allergies'}, 'identificationModule': {'nctId': 'NCT01121003', 'acronym': 'FRUCTEXER', 'briefTitle': 'Effects of Fructose and Exercise on Hepatic Lipid Metabolism', 'organization': {'class': 'OTHER', 'fullName': 'University of Lausanne'}, 'officialTitle': 'Effects of a Weight Maintenance, High Fructose Diet and of Exercise on Hepatic Lipid Metabolism', 'orgStudyIdInfo': {'id': 'Protocole 220/09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Low fructose diet/no exercise', 'interventionNames': ['Behavioral: weight maintenance, low sugar diet']}, {'type': 'EXPERIMENTAL', 'label': 'high fructose diet/no exercise', 'interventionNames': ['Behavioral: weight maintenance, high fructose diet']}, {'type': 'EXPERIMENTAL', 'label': 'high fructose diet+exercise', 'interventionNames': ['Behavioral: weight maintenance, high fructose diet+ exercise']}], 'interventions': [{'name': 'weight maintenance, low sugar diet', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Low fructose diet/no exercise']}, {'name': 'weight maintenance, high fructose diet', 'type': 'BEHAVIORAL', 'armGroupLabels': ['high fructose diet/no exercise']}, {'name': 'weight maintenance, high fructose diet+ exercise', 'type': 'BEHAVIORAL', 'armGroupLabels': ['high fructose diet+exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CH-1011', 'city': 'Lausanne', 'state': 'Canton of Vaud', 'country': 'Switzerland', 'facility': 'Centre Hospitalier Universitaire Vaudois', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'Luc Tappy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Lausanne'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Lausanne', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre Hospitalier Universitaire Vaudois', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Physiology', 'investigatorFullName': 'Luc Tappy, MD', 'investigatorAffiliation': 'University of Lausanne'}}}}