Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2025-12-25 @ 5:31 PM
Study NCT ID:
NCT06660004
Status:
COMPLETED
Last Update Posted:
2025-12-16
First Post:
2024-10-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Creatine HCl and Creatine Ethyl Ester Supplementation in Perimenopausal and Menopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2024-10-24', 'studyFirstSubmitQcDate': '2024-10-24', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fatigue', 'timeFrame': 'Change from baseline fatigue at 8 weeks', 'description': 'Level of fatigue as assessed by the Multidimensional Fatigue Inventory (MFI)'}], 'secondaryOutcomes': [{'measure': 'Time to exhaustion', 'timeFrame': 'Change from baseline time to exhaustion at 8 weeks', 'description': 'Running time to exhaustion during incrementaltestontreadmill'}, {'measure': 'Brain creatine', 'timeFrame': 'Change from baseline brain creatine concentrations at 8 weeks', 'description': 'Magnetic resonance spectra for brain creatine concentrations'}, {'measure': 'Cognitive interference', 'timeFrame': 'Change from baseline fatigue at 8 weeks', 'description': 'Ability to inhibit cognitive interference as assessed by the The Stroop Color and Word Test'}, {'measure': 'Amyloid b', 'timeFrame': 'Change from baseline time to exhaustion at 8 weeks', 'description': 'Serum levels of amyloid b'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['creatine', 'brain metabolism', 'cognition', 'fatigue'], 'conditions': ['Menopausal', 'Perimenopause']}, 'referencesModule': {'references': [{'pmid': '39055234', 'type': 'BACKGROUND', 'citation': 'Ostojic SM, Stea TH, Ellery SJ, Smith-Ryan AE. Association between dietary intake of creatine and female reproductive health: Evidence from NHANES 2017-2020. Food Sci Nutr. 2024 Apr 30;12(7):4893-4898. doi: 10.1002/fsn3.4135. eCollection 2024 Jul.'}, {'pmid': '40854087', 'type': 'DERIVED', 'citation': 'Korovljev D, Ostojic J, Panic J, Ranisavljev M, Todorovic N, Nedeljkovic D, Kuzmanovic J, Vranes M, Stajer V, Ostojic SM. The Effects of 8-Week Creatine Hydrochloride and Creatine Ethyl Ester Supplementation on Cognition, Clinical Outcomes, and Brain Creatine Levels in Perimenopausal and Menopausal Women (CONCRET-MENOPA): A Randomized Controlled Trial. J Am Nutr Assoc. 2025 Aug 25:1-12. doi: 10.1080/27697061.2025.2551184. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this randomized controlled double-blind parallel-group interventional trial is to evaluate the effects of of dietary supplementation with creatine HCl and creatine ethyl ester supplementation on cognitive performance, multidimensional fatigue, brain metabolism, and biochemical indices in perimenopausal and menopausal women'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index 18.5 - 29.9 kg/m2\n* Free of major chronic diseases or acute disorders (including AD and dementia (MMSE score \\> 25 points)\n* MENOPAUSAL: no menstrual cycle for consecutive 12 months (with no other obvious causes)\n* PERIMENOPAUSAL: Still menstruating (regular or irregular) but have at least one of the following symptoms: (1) hot flashes, (2) sleep disturbances, (3) mood swings, and (4) concentration difficulties\n* Given written informed consent\n\nExclusion Criteria:\n\n* History of dietary supplement use 4 weeks before the study commences\n* Pregnancy (or planning pregnancy)\n* Abnormal values for lab clinical chemistry (\\> 2 SD)\n* Unwillingness to return for follow-up analysis\n* Participation in other clinical trials'}, 'identificationModule': {'nctId': 'NCT06660004', 'acronym': 'CONCRET-MENOPA', 'briefTitle': 'Creatine HCl and Creatine Ethyl Ester Supplementation in Perimenopausal and Menopausal Women', 'organization': {'class': 'OTHER', 'fullName': 'University of Novi Sad, Faculty of Sport and Physical Education'}, 'officialTitle': 'The Effects of 8-Week Creatine HCl and Creatine Ethyl Ester Supplementation on Cognitive Performance, Multidimensional Fatigue, Brain Metabolism, and Biochemical Indices in Perimenopausal and Menopausal Women', 'orgStudyIdInfo': {'id': 'CC-1-24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Creatine hcl', 'description': 'One capsule per day of creatine hcl during breakfast', 'interventionNames': ['Dietary Supplement: Dietary Supplement: Experimental 1 Creatine HCl']}, {'type': 'EXPERIMENTAL', 'label': 'Creatine hcl 2', 'description': 'One capsule during breakfast and one during dinner of creatine hcl', 'interventionNames': ['Dietary Supplement: Dietary Supplement: Experimental 2 Creatine HCl']}, {'type': 'EXPERIMENTAL', 'label': 'Creatine ethyl ester', 'description': 'One capsule during breakfast and one during dinner of creatine ethyl ester', 'interventionNames': ['Dietary Supplement: Dietary Supplement: Experimental 3 Creatine Ethyl ester']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'One capsule per day of inulin during breakfast', 'interventionNames': ['Dietary Supplement: Dietary Supplement: Experimental 4 Placebo']}], 'interventions': [{'name': 'Dietary Supplement: Experimental 1 Creatine HCl', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Creatine hcl', 'armGroupLabels': ['Creatine hcl']}, {'name': 'Dietary Supplement: Experimental 2 Creatine HCl', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Creatine hcl', 'armGroupLabels': ['Creatine hcl 2']}, {'name': 'Dietary Supplement: Experimental 3 Creatine Ethyl ester', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Creatine ethyl ester', 'armGroupLabels': ['Creatine ethyl ester']}, {'name': 'Dietary Supplement: Experimental 4 Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21000', 'city': 'Novi Sad', 'state': 'Vojvodina', 'country': 'Serbia', 'facility': 'FSPE Applied BIoenergetcis Lab', 'geoPoint': {'lat': 45.25167, 'lon': 19.83694}}], 'overallOfficials': [{'name': 'Sergej Ostojic, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Applied BIoenergetics Lab'}]}, 'ipdSharingStatementModule': {'url': 'https://www.appliedbioenergetics.org/', '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 perimenopause. 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': 'Data obtained through this study may be provided to qualified researchers with academic interest in perimenopause.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Novi Sad, Faculty of Sport and Physical Education', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Head of the Applied Bioenergetics Lab', 'investigatorFullName': 'Sergej Ostojic', 'investigatorAffiliation': 'University of Novi Sad, Faculty of Sport and Physical Education'}}}}