Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
Study NCT ID:
NCT06202469
Status:
COMPLETED
Last Update Posted:
2024-12-04
First Post:
2023-12-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Creatine and Ubiquinol for Sperm Quality
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009845', 'term': 'Oligospermia'}], 'ancestors': [{'id': 'D007248', 'term': 'Infertility, Male'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000602145', 'term': 'TARGET 1 dietary supplement'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2023-12-28', 'studyFirstSubmitQcDate': '2024-01-09', 'lastUpdatePostDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sperm concentration', 'timeFrame': 'Change from baseline sperm concentration at 8 weeks', 'description': 'Number of sperm per milliliter of semen'}], 'secondaryOutcomes': [{'measure': 'Total antioxidant capacity', 'timeFrame': 'Change from baseline total antioxidant capacity at 8 weeks', 'description': 'Level of total antioxidant capacity in semen'}, {'measure': 'Creatine kinase', 'timeFrame': 'Change from baseline creatine kinase at 8 weeks', 'description': 'Level of creatine kinase in semen'}, {'measure': 'Creatine', 'timeFrame': 'Change from baseline creatine at 8 weeks', 'description': 'Level of creatine in semen'}, {'measure': 'The World Health Organisation-Five Well-Being Index (WHO-5)', 'timeFrame': 'Change from baseline WHO-5 at 8 weeks', 'description': 'The World Health Organisation-Five Well-Being Index (WHO-5) is a short self-reported measure of current mental wellbeing.The raw scores are transformed to a score from 0 to 100, with lower scores indicating worse well-being.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oligospermia', 'Sperm Count, Low']}, 'referencesModule': {'references': [{'pmid': '35276945', 'type': 'BACKGROUND', 'citation': 'Ostojic SM, Stea TH, Engeset D. Creatine as a Promising Component of Paternal Preconception Diet. Nutrients. 2022 Jan 28;14(3):586. doi: 10.3390/nu14030586.'}, {'pmid': '41052075', 'type': 'DERIVED', 'citation': 'Nedeljkovic D, Todorovic N, Javorac D, Baltic S, Vranes M, Panic J, Kladar N, Ratgeber L, Betlehem J, Acs P, Stea TH, Engeset D, Stajer V, Ostojic SM. The effects of 8-week creatine supplementation with and without ubiquinol on sperm quality biomarkers in normospermic and oligospermic men: A randomized controlled pilot trial. Nutr Health. 2025 Oct 6:2601060251385000. doi: 10.1177/02601060251385000. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'This randomized controlled double-blind parallel-group interventional trial explores the impact of 8-week creatine supplementation, with or without ubiquinol, on sperm quality biomarkers in normospermic and oligospermic men. It aims to determine potential enhancements in sperm health to provide insights into male fertility and reproductive health improvement strategies.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 - 35 years\n* Sperm quality test available (at least half will have low sperm quality)\n* Informed consent\n* Healthy BMI (18.5 - 24.9 kg/m2)\n\nExclusion Criteria:\n\n* Major chronic disease and acute injuries\n* History of dietary supplement use during the past 28 days\n* No consent to randomization\n* Participation in other studies'}, 'identificationModule': {'nctId': 'NCT06202469', 'acronym': 'CRESPAQ10', 'briefTitle': 'Creatine and Ubiquinol for Sperm Quality', 'organization': {'class': 'OTHER', 'fullName': 'University of Novi Sad, Faculty of Sport and Physical Education'}, 'officialTitle': 'The Effects of 8-week Creatine Supplementation With and Without Ubiquinol on Sperm Quality Biomarkers in Normospermic and Oligospermic Men', 'orgStudyIdInfo': {'id': 'CR-24-AK15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supplement 1', 'description': 'Creatine monohydrate', 'interventionNames': ['Dietary Supplement: Supplement 1']}, {'type': 'EXPERIMENTAL', 'label': 'Supplement 2', 'description': 'Creatine monohydrate plus ubiquinol', 'interventionNames': ['Dietary Supplement: Supplement 2']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Inulin', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Supplement 1', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Creatine monohydrate (5 g/day)', 'armGroupLabels': ['Supplement 1']}, {'name': 'Supplement 2', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Creatine monohydrate (5 g/day) plus ubiquinol (200 mg/day)', 'armGroupLabels': ['Supplement 2']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo (inulin)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21000', 'city': 'Novi Sad', 'state': 'Vojvodina', 'country': 'Serbia', 'facility': 'FSPE Applied Bioenergetics Lab', 'geoPoint': {'lat': 45.25167, 'lon': 19.83694}}], 'overallOfficials': [{'name': 'Sergej Ostojic, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Novi Sad'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.', 'ipdSharing': 'YES', 'description': 'Data obtained through this study may be provided to qualified researchers with academic interest in sperm quality. Data will be coded, with no PHI included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.', 'accessCriteria': 'Only qualified researchers with academic interest in sperm quality'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Novi Sad, Faculty of Sport and Physical Education', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sergej Ostojic', 'investigatorAffiliation': 'University of Novi Sad, Faculty of Sport and Physical Education'}}}}