Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2025-12-25 @ 11:09 PM
Study NCT ID:
NCT04615767
Status:
COMPLETED
Last Update Posted:
2021-08-02
First Post:
2020-10-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
D-chiro-inositol Increases Androgens and Reduces Estrogens in Human Serum
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Ten male volunteers are treated daily with 1 g D-chiro-inositol for 30 days (2 capsules containing 500 mg each, twice a day). The serum levels of the detected parameters at the end of treatment are compared to the values found in the volunteers at the baseline, used as controls. Parameters under analysis: Testosterone/Estradiol ratio, Testosterone, dehydroepiandrosterone, estradiol, estrone, glycemia and insulinemia with Homeostatic Model Assessment for Insulin Resistance (HOMA) index, follicle stimulating hormone, luteinizing hormone, D-chiro-inositol and myo-inositol.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-12-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-30', 'studyFirstSubmitDate': '2020-10-29', 'studyFirstSubmitQcDate': '2020-11-03', 'lastUpdatePostDateStruct': {'date': '2021-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement of the Testosterone/Estradiol ratio in serum', 'timeFrame': 'Thirty days', 'description': 'Assessment of the D-Chiro-Inositol treatment to increase the Testosterone/Estradiol ratio by detecting these physiological parameters in serum'}], 'secondaryOutcomes': [{'measure': 'Dehydroepiandrosterone sulfate', 'timeFrame': 'Thirty days', 'description': 'Detecting the serum levels of Dehydroepiandrosterone sulfate'}, {'measure': 'Estrone', 'timeFrame': 'Thirty days', 'description': 'Detecting the serum levels of Estrone'}, {'measure': 'Homeostatic Model Assessment for Insulin Resistance (HOMA) Index', 'timeFrame': 'Thirty days', 'description': 'Detecting glycemia and insulinemia'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Testosterone', 'DHEAS', 'Estradiol', 'Estrone', 'HOMA index', 'D-chiro-inositol'], 'conditions': ['Low Serum Testosterone Levels in Man']}, 'referencesModule': {'references': [{'pmid': '34078260', 'type': 'DERIVED', 'citation': 'Monastra G, Vazquez-Levin M, Bezerra Espinola MS, Bilotta G, Lagana AS, Unfer V. D-chiro-inositol, an aromatase down-modulator, increases androgens and reduces estrogens in male volunteers: a pilot study. Basic Clin Androl. 2021 Jun 3;31(1):13. doi: 10.1186/s12610-021-00131-x.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this pilot study is to test the effect of a 30 day-D-chiro-inositol oral treatment on a set of clinical parameters (mainly sex hormones) in a group of male volunteers selected by their age and BMI to investigate if D-chiro-inositol acts as an aromatase inhibitor.', 'detailedDescription': 'This is an open label clinical trial with a dietary supplement carried out in male volunteers selected by their age and BMI. The aim is to test the effect of oral daily treatment with 1 g D-chiro-inositol for 30 days on some clinical parameters, to see if D-chiro-inositol acts as an aromatase inhibitor. Testosterone, estradiol, Testosterone/Estradiol ratio, Dehydroepiandrosterone sulfate, Estrone, glycemia and insulinemia (with calculation of HOMA index), follicle-stimulating hormone, Luteinizing hormone, D-chiro-inositol and Myo-inositol serum concentrations have to be determined before and after D-chiro-inositol administration.\n\nWe wish to evaluate if this treatment for one month is able to change the sexual hormone levels, increasing androgens and decreasing estrogens. Furthermore, we wish to control the safety profile of D-chiro-inositol, a well-known molecule, different from the classic aromatase inhibitors. We think that our pilot study can open up new perspectives of research and therapeutic applications for this many-sided molecule.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index (BMI) range is between 22 and 34 kg/m2, in order to include subjects with normal weight, overweight and obese. Subjects with altered glycemia or hormonal status due to age or weight were enrolled in the study.\n\nExclusion Criteria:\n\n* Men with poor general health were excluded from the study.'}, 'identificationModule': {'nctId': 'NCT04615767', 'briefTitle': 'D-chiro-inositol Increases Androgens and Reduces Estrogens in Human Serum', 'organization': {'class': 'OTHER', 'fullName': 'AGUNCO Obstetrics and Gynecology Centre'}, 'officialTitle': 'D-chiro-inositol, a Putative Aromatase Inhibitor, Increases Androgen and Reduces Estrogen Levels in Serum of Male Volunteers. A Pilot Study.', 'orgStudyIdInfo': {'id': 'UVittorio1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'D-chiro-inositol', 'description': 'Volunteers are orally administered with 1 g D-chiro-inositol per day (two doses in capsules of 500 mg each, one in the morning and the other one in the evening) for thirty days', 'interventionNames': ['Dietary Supplement: D-chiro-inositol']}], 'interventions': [{'name': 'D-chiro-inositol', 'type': 'DIETARY_SUPPLEMENT', 'description': 'as described previously', 'armGroupLabels': ['D-chiro-inositol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00198', 'city': 'Rome', 'country': 'Italy', 'facility': 'Clinica Alma Res', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': 'Giovanni Monastra', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Systems Biology Group Lab, Rome, Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AGUNCO Obstetrics and Gynecology Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}