Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2026-01-01 @ 2:46 PM
Study NCT ID:
NCT05348304
Status:
COMPLETED
Last Update Posted:
2022-10-13
First Post:
2022-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypoglycemic Effects of a Dietary Supplement With Inositols, Gymnema Silvestre, Alpha-lactalbumin and Zinc.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008659', 'term': 'Metabolic Diseases'}], 'ancestors': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-12', 'studyFirstSubmitDate': '2022-04-21', 'studyFirstSubmitQcDate': '2022-04-21', 'lastUpdatePostDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulinemia', 'timeFrame': 'Three time points: change in insulin levels from the baseline to three and six months', 'description': 'Reduction of systemic insulin levels'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metabolism Disorder']}, 'descriptionModule': {'briefSummary': 'This study is aimed at evaluating the hypoglycemic effects of a dietary supplement that associates the properties of two inositols (myo-inositol and D-chiro-inositol) in the ratio 40:1 to Gymnema sylvestre, alpha-lactalbumin and zinc.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI between 30 and 35\n* Basal Glycemia between 100 and 125 mg/dl\n\nExclusion Criteria:\n\n* Diabetes diagnosis\n* Use of food supplements containing inositols, gymnema, alpha-lactalbumin and zinc\n* Intolerance to inositols, gymnema, alpha-lactalbumin and zinc'}, 'identificationModule': {'nctId': 'NCT05348304', 'acronym': 'EUDIA_22', 'briefTitle': 'Hypoglycemic Effects of a Dietary Supplement With Inositols, Gymnema Silvestre, Alpha-lactalbumin and Zinc.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lo.Li.Pharma s.r.l'}, 'officialTitle': 'Hypoglycemic Effects of a Dietary Supplement That Combines the Properties of Myo-inositol and D-chiro-inositol With Gymnema Silvestre, Alpha-lactalbumin and Zinc.', 'orgStudyIdInfo': {'id': 'EUDIA_22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Hypocaloric diet'}, {'type': 'EXPERIMENTAL', 'label': 'EUDIAMET', 'description': 'Hypocaloric diet plus a supplementation with myo-inositol and D-chiro-inositol in the 40:1 ratio, Gymnema sylvestre, alpha-lactalbumin and zinc', 'interventionNames': ['Dietary Supplement: EUDIAMET']}], 'interventions': [{'name': 'EUDIAMET', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A combination of myo-inositol and D-chiro-inositol in the 40:1 ratio, Gymnema sylvestre, alpha-lactalbumin and zinc', 'armGroupLabels': ['EUDIAMET']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00161', 'city': 'Rome', 'state': 'RM', 'country': 'Italy', 'facility': 'Sapienza University of Rome', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': 'Sabrina Basciani', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Roma La Sapienza'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lo.Li.Pharma s.r.l', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}