Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2025-12-31 @ 12:04 AM
Study NCT ID:
NCT06606704
Status:
RECRUITING
Last Update Posted:
2024-09-23
First Post:
2024-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Resistance-band Training and Creatine Supplementation Strategies in Healthy Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, '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': 52}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-18', 'studyFirstSubmitDate': '2024-09-16', 'studyFirstSubmitQcDate': '2024-09-18', 'lastUpdatePostDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Whole-body lean mass (kg)', 'timeFrame': 'baseline, week 16', 'description': 'Bioelectrical impedance analysis'}, {'measure': 'Muscle Hypertrophy (cm)', 'timeFrame': 'baseline, week 16', 'description': 'B-mode ultrasound'}, {'measure': 'Strength (kg)', 'timeFrame': 'baseline, week 16', 'description': '1-repetition maximum leg press and chest press'}, {'measure': 'Endurance (number of repetitions to fatigue)', 'timeFrame': 'baseline, week 16', 'description': 'Leg press and chest press'}, {'measure': 'Power (feet)', 'timeFrame': 'baseline, week 16', 'description': 'medicine ball throw'}, {'measure': 'Balance (Centre of Pressure)', 'timeFrame': 'baseline, week 16', 'description': 'Force Plate'}, {'measure': 'Gait Speed (meters)', 'timeFrame': 'baseline, week 16', 'description': 'Walking distance'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aging', 'Creatine', 'Resistance-Bands', 'Muscle', 'Strength'], 'conditions': ['Aging']}, 'descriptionModule': {'briefSummary': 'The primary purpose is to compare the effects of creatine supplementation (bolus ingestion of 5 grams vs. 3 grams) during 16 weeks of resistance-band training on measures of body composition (i.e., whole-body lean tissue mass, total body water), arm and leg muscle thickness (growth), muscle performance (i.e., power, strength, endurance) and functional ability (i.e., walking speed, balance).\n\nA secondary purpose of this research is to examine the effects of bolus ingestion of creatine (5 grams) compared to intermittent ingestion of creatine (2 x 2.5 grams) during 16 weeks of resistance-band training on measures of body composition (i.e., whole-body lean tissue mass, total body water), arm and leg muscle thickness (growth), muscle performance (i.e., power, strength, endurance) and functional ability (i.e., walking speed, balance).', 'detailedDescription': 'Resistance-band training is safe, conveient, easy-to-use, eliminates potential barriers to exercise participation (i.e., lack of transportation to and from commercial training facilities) and results in high exercise compliance and adherence. Further, resistance-band training results in similar improvements in muscle performance and functional ability compared to traditional resistance-type training using free-weights and machines.\n\nCreatine is a naturally occurring nitrogen-containing compound produced in the body in the liver and brain and can also be found in food products such as red meat and seafood or through commercially available manufactured creatine products.\n\nEvidence-based research shows that creatine supplementation, when ingested during a resistance exercise training program, improves measures of lean mass and muscle growth, muscle performance and functional ability. However, the optimal creatine supplementation protocol to achieve these benefits is unknown.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* if you are 50 years of age and older\n* if you have not been performing more than 1 resistance training session per week for the past 6 weeks or more.\n\nExclusion Criteria:\n\n* if you have taken creatine supplements 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': 'NCT06606704', 'briefTitle': 'Effects of Resistance-band Training and Creatine Supplementation Strategies in Healthy Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of Regina'}, 'officialTitle': 'Effects of Resistance-band Training and Creatine Supplementation in Healthy Older Adults', 'orgStudyIdInfo': {'id': '853'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Creatine Bolus 5', 'interventionNames': ['Dietary Supplement: Creatine Bolus 5']}, {'type': 'EXPERIMENTAL', 'label': 'Creatine Bolus 3', 'interventionNames': ['Dietary Supplement: Creatine Bolus 3']}, {'type': 'EXPERIMENTAL', 'label': 'Creatine Intermittent 5', 'interventionNames': ['Dietary Supplement: Creatine Intermittent 5']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Creatine Bolus 5', 'type': 'DIETARY_SUPPLEMENT', 'description': '(Serving 1: 5 grams of creatine + 3 grams of placebo in the morning; Serving 2: 8 grams of placebo at least 6 hours after Serving 1).', 'armGroupLabels': ['Creatine Bolus 5']}, {'name': 'Creatine Bolus 3', 'type': 'DIETARY_SUPPLEMENT', 'description': '(Serving 1: 3 grams of creatine + 5 grams of placebo in the morning; Serving 2: 8 grams of placebo at least 6 hours after Serving 1).', 'armGroupLabels': ['Creatine Bolus 3']}, {'name': 'Creatine Intermittent 5', 'type': 'DIETARY_SUPPLEMENT', 'description': '(Serving 1: 2.5 grams of creatine + 5.5 grams of placebo in the morning, Serving 2: 2.5 grams of creatine + 5.5 grams of placebo at least 6 hours after Serving 1).', 'armGroupLabels': ['Creatine Intermittent 5']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '(Serving: 8 grams of placebo in the morning; Servings 2: 8 grams of placebo at least 6 hours after Serving 1).', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S4S4H4', 'city': 'Regina', 'state': 'Saskatchewan', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Darren G Candow, PhD', 'role': 'CONTACT', 'email': 'Darren.Candow@uregina.ca', 'phone': '3062090280'}, {'name': 'Darren G Candow, PhD', 'role': 'CONTACT'}], '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'}}}}