Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-25 @ 5:22 PM
Study NCT ID:
NCT00742703
Status:
COMPLETED
Last Update Posted:
2009-03-09
First Post:
2008-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of the Effects of a Mineralized Water Ingestion Upon Lipidic Absorption Mechanisms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'lastUpdateSubmitDate': '2009-03-06', 'studyFirstSubmitDate': '2008-08-27', 'studyFirstSubmitQcDate': '2008-08-27', 'lastUpdatePostDateStruct': {'date': '2009-03-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood LDL Cholesterol rate.', 'timeFrame': 'Day-1, day-56, day-63, day-119 of study'}, {'measure': 'Post-prandial blood triglycerides rate.', 'timeFrame': 'Day-1, day-56, day-63, day-119 of the study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Moderated Cholesterolemia']}, 'descriptionModule': {'briefSummary': 'The principal objective of this research is the evaluation of the effect of mineralized water consumption upon evolution of LDL Cholesterol and triglycerides, compared to a low mineralized water consumption.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI included between 18.5 and 25 kg/m²\n* non smoking\n* moderated hypercholesterolemia\n\nExclusion Criteria:\n\n* food allergy\n* diabetes\n* high blood pressure\n* kidney deficiency\n* thyroid deficiency\n* metabolism deficiency'}, 'identificationModule': {'nctId': 'NCT00742703', 'briefTitle': 'Study of the Effects of a Mineralized Water Ingestion Upon Lipidic Absorption Mechanisms', 'organization': {'class': 'INDUSTRY', 'fullName': 'Multimed'}, 'officialTitle': 'Study of the Effects of a Mineralized Water Ingestion Upon Lipidic Absorption Mechanisms', 'orgStudyIdInfo': {'id': '9808'}, 'secondaryIdInfos': [{'id': 'IDRCB: 2008-A00743-52'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Other: Mineralized water']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Other: Low mineralized water']}], 'interventions': [{'name': 'Mineralized water', 'type': 'OTHER', 'armGroupLabels': ['1']}, {'name': 'Low mineralized water', 'type': 'OTHER', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44200', 'city': 'Nantes', 'country': 'France', 'facility': 'Biofortis', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}], 'overallOfficials': [{'name': 'Zaïr Yassine, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'BioFortis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Multimed', 'class': 'INDUSTRY'}}}}