Ignite Creation Date:
2025-12-24 @ 5:20 PM
Ignite Modification Date:
2026-01-29 @ 11:50 AM
Study NCT ID:
NCT03393650
Status:
COMPLETED
Last Update Posted:
2018-01-08
First Post:
2016-12-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Protein Supplementation and Mixed Power Training on Muscle Function and Functional Capacities in Elderly Men
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-02', 'studyFirstSubmitDate': '2016-12-15', 'studyFirstSubmitQcDate': '2018-01-02', 'lastUpdatePostDateStruct': {'date': '2018-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in mitochondrial activity', 'timeFrame': 'Change from Baseline mitochondrial activity at 12 weeks measure in half of the subjects', 'description': 'citrate synthase activity (unit: percent)'}], 'primaryOutcomes': [{'measure': 'Change in walking speed', 'timeFrame': 'Change from Baseline walking speed at 12 weeks measure in all subjects', 'description': 'evaluate using the 4m- normal walking speed (m/sec)'}], 'secondaryOutcomes': [{'measure': 'Change in lower limb muscle quality', 'timeFrame': 'Change from Baseline lower limb muscle quality at 12 weeks measure in all subjects', 'description': 'Knee extension muscle strength (isometric (N)/ lower limb muscle mass (kg))'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['exercise', 'protein', 'muscle function', 'aging'], 'conditions': ['Dynapenia', 'Aging', 'Physical Impairment']}, 'descriptionModule': {'briefSummary': 'Investigate the effect of 12 weeks mixed power training (power and functional exercises) combined with a protein supplementation (30g/d) or not (placebo) on physiological characteristics of muscle and functional capacities in elderly men.', 'detailedDescription': "Life habits are know to be able to prevent the loss of functional capacities and muscle function during aging process. More specifically, protein intake is important to maintain muscle function in older adults. Another non pharmacological intervention and well recognized for its efficacy, it's exercise training.\n\nRecently, it has been observed than muscle quality is more important to maintain physical autonomy than muscle mass per se. In addition, muscle quality is more related to functional capacities than muscle mass.\n\nDue to this recent finding, it has been proposed that muscle power training would be the best exercise intervention to prevent the loss of mobility."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elderly men\n* 60 years and older\n* Sedentary men\n* Not obese (BMI \\<30 kg/m2)\n* Living in free-living community\n\nExclusion Criteria:\n\n* Not able to follow an exercise program (doctor authorization: XAAP)\n* Having Lactose intolerance\n* Having Pace marker\n* Having Metabolism disorder\n* No weight stable since the last 6 months\n* No stable medication (same dose and type since at least 6 months)'}, 'identificationModule': {'nctId': 'NCT03393650', 'acronym': 'PROMU', 'briefTitle': 'Protein Supplementation and Mixed Power Training on Muscle Function and Functional Capacities in Elderly Men', 'organization': {'class': 'OTHER', 'fullName': 'Université du Québec a Montréal'}, 'officialTitle': 'Effect of Protein Supplementation Combined With Mixed Power Training on Muscle Function, Composition, Phenotype and Functional Capacities Compared to Mixed Power Training Alone in Elderly Men', 'orgStudyIdInfo': {'id': 'UQAM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Exercise + Placebo group', 'description': '50 subjects will receive a placebo supplementation with an exercise intervention (EX group)', 'interventionNames': ['Other: Exercise + Placebo group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Exercise + Protein group', 'description': '50 subjects will receive a protein supplementation combined with an exercise intervention (PROTEX group)', 'interventionNames': ['Other: Exercise + Protein group']}], 'interventions': [{'name': 'Exercise + Placebo group', 'type': 'OTHER', 'description': '1/2 of the subject will follow a mixed power training: 4 power exercises + 6 functional exercises combined to a placebo', 'armGroupLabels': ['Exercise + Placebo group']}, {'name': 'Exercise + Protein group', 'type': 'OTHER', 'description': '1/2 of the subject will receive 30 g/ d of protein (leucine+ vitD; divided in three equal doses: morning, afternoon and evening) + will follow a mixed power training: 4 power exercises + 6 functional exercises.', 'armGroupLabels': ['Exercise + Protein group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'mylene aubertin-leheudre, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université du Québec a Montréal'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université du Québec a Montréal', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Mylène Aubertin-Leheudre', 'investigatorAffiliation': 'Université du Québec a Montréal'}}}}