Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-01-01 @ 3:04 PM
Study NCT ID:
NCT06604793
Status:
RECRUITING
Last Update Posted:
2024-09-20
First Post:
2024-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Creatine Supplementation in Young Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003401', 'term': 'Creatine'}], 'ancestors': [{'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-17', 'studyFirstSubmitDate': '2024-09-17', 'studyFirstSubmitQcDate': '2024-09-17', 'lastUpdatePostDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Whole-body lean mass (kg)', 'timeFrame': 'baseline, day 21', 'description': 'Bioelectrical impedance analysis'}, {'measure': 'Strength', 'timeFrame': 'baseline, day 21', 'description': '1-repetition maximum leg press and chest press (kg)'}, {'measure': 'Endurance', 'timeFrame': 'baseline, day 21', 'description': 'Repetitions to fatigue for leg press and chest press (total number)'}, {'measure': 'Hydration', 'timeFrame': 'baseline, day 21', 'description': 'Total body water (kg) using bioelectrical impedance analysis'}, {'measure': 'Power', 'timeFrame': 'baseline, day 21', 'description': 'Vertical Jump (cm)'}, {'measure': 'Power', 'timeFrame': 'baseline, day 21', 'description': 'Medicine Ball Throw (feet)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Improve Muscle Performance in Young Adults']}, 'descriptionModule': {'briefSummary': 'The purpose is to compare the effects of bolus ingestion (5 grams) vs. intermittent ingestion (2 x 2.5 grams) of creatine supplementation vs. placebo for 21 days on measures of body composition (lean tissue mass-indicator of muscle mass, total body water) and muscle performance (i.e., power, strength, endurance).', 'detailedDescription': 'Creatine is a naturally occurring compound produced in the liver and brain. Creatine can also be found in food products such as red meat and seafood or through commercially available manufactured creatine products (i.e. creatine supplementation).\n\nEvidence-based research shows that creatine supplementation improves measures of body composition and muscle performance. However, the optimal creatine supplementation protocol to achieve these benefits is unknown.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* if you are 18-39 years of age\n* if you have not been performing resistance training for at least 4 weeks prior to the start of the study.\n\nExclusion Criteria:\n\n* if you are pregnant or nursing\n* have taken creatine monohydrate within 30 days prior to the start of the study\n* if you have pre-existing allergies to the placebo (corn-starch maltodextrin)'}, 'identificationModule': {'nctId': 'NCT06604793', 'briefTitle': 'Creatine Supplementation in Young Healthy Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of Regina'}, 'officialTitle': 'Effects of Equal-volume Creatine Supplementation With Different Dosing Strategies on Body Composition and Muscle Performance in Young Healthy Adults', 'orgStudyIdInfo': {'id': '834'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Creatine Bolus', 'description': '(Serving 1: 5 grams of creatine monohydrate + 3 grams of placebo in the morning; Serving 2: 8 grams of placebo in the evening) for 21 days.', 'interventionNames': ['Dietary Supplement: Creatine']}, {'type': 'EXPERIMENTAL', 'label': 'Creatine Intermittent', 'description': '(Serving 1: 2.5 grams of creatine monohydrate + 5.5 grams of placebo in the morning; Serving 2: 2.5 grams of creatine monohydrate + 5.5 grams of placebo in the evening) for 21 days.', 'interventionNames': ['Dietary Supplement: Creatine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '(Servings 1: 8 grams of placebo in the morning; Serving 2: 8 grams of placebo in the evening) for 21 days.', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Creatine', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Creatine monohydrate', 'armGroupLabels': ['Creatine Bolus', 'Creatine Intermittent']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Maltodextrin', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S4S 0A2', 'city': 'Regina', 'state': 'Saskatchewan', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Darren Candow', 'role': 'CONTACT', 'email': 'Darren.Candow@uregina.ca', 'phone': '306-585-4096'}], 'facility': 'University of Regina', 'geoPoint': {'lat': 50.45008, 'lon': -104.6178}}], 'centralContacts': [{'name': 'Darren Candow', 'role': 'CONTACT', 'email': 'Darren.Candow@uregina.ca', 'phone': '306-585-4906'}], 'overallOfficials': [{'name': 'Darren Candow', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Regina'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Regina', 'class': 'OTHER'}, 'collaborators': [{'name': 'Iovate Health Sciences International Inc', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Darren Candow', 'investigatorAffiliation': 'University of Regina'}}}}