Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-26 @ 6:58 PM
Study NCT ID:
NCT05019859
Status:
COMPLETED
Last Update Posted:
2022-06-02
First Post:
2021-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of a Low Carb Diet on Erectile Function and Serem Testosterone in Men With Metabolic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D007006', 'term': 'Hypogonadism'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Controlled Trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-27', 'studyFirstSubmitDate': '2021-08-18', 'studyFirstSubmitQcDate': '2021-08-18', 'lastUpdatePostDateStruct': {'date': '2022-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'testosterone', 'timeFrame': 'three months', 'description': 'serum total testosterone level'}], 'secondaryOutcomes': [{'measure': 'IIEF 5', 'timeFrame': 'three months', 'description': 'International Index of Erectile Function 5'}, {'measure': 'AMS', 'timeFrame': 'three months', 'description': 'Age male Symptom score'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['low carb diet', 'hypogonadism', 'metabolic syndrome'], 'conditions': ['Testosterone Deficiency', 'Metabolic Syndrome', 'Diet Modification']}, 'descriptionModule': {'briefSummary': 'Investigate if low carb diet could increase serum testosterone level in hypogonadic men', 'detailedDescription': 'Randomized controlled trial to evaluate the effect of low carb diet in men with metabolic syndrome and low testosterone level. The inclusion criteria is men with metabolic syndrome and serum total testosterone below 300 ng/dL. They will randomized to perform a low carb diet or a traditional low fat diet for metabolic syndrome. The follow up will be of three months with a once a month visit. Even though these men will be looked at their sexuality and life style. They will be monitoring by urologists and nutritionists during the study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* metabolic syndrome, serum testosterone level below 300 ng/dL\n\nExclusion Criteria:\n\n* active cancer, diet allergies, psychological incapability'}, 'identificationModule': {'nctId': 'NCT05019859', 'briefTitle': 'Effects of a Low Carb Diet on Erectile Function and Serem Testosterone in Men With Metabolic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Moinhos de Vento'}, 'officialTitle': 'Effects of a Low Carb Diet on Erectile Function and Serem Testosterone in Men With Metabolic Syndrome', 'orgStudyIdInfo': {'id': 'HMoinhosVento'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention', 'description': 'low carb diet', 'interventionNames': ['Behavioral: low carb diet']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'traditional low fat diet'}], 'interventions': [{'name': 'low carb diet', 'type': 'BEHAVIORAL', 'description': 'low carb diet', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90035-903', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital de Clínicas Porto Alegre', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}], 'overallOfficials': [{'name': 'Brasil S Neto, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital de Clínicas Porto Alegre'}, {'name': 'Caio S Schmitt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Moinhos de Vento and Hospital de Clínicas Porto Alegre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Moinhos de Vento', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital de Clinicas de Porto Alegre', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}