Protein Supplementation and Mixed Power Training on Muscle Function and Functional Capacities in Elderly Men
PROMU
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
1 other identifier
interventional
100
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2013
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 15, 2016
CompletedFirst Posted
Study publicly available on registry
January 8, 2018
CompletedJanuary 8, 2018
January 1, 2018
2.2 years
December 15, 2016
January 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in walking speed
evaluate using the 4m- normal walking speed (m/sec)
Change from Baseline walking speed at 12 weeks measure in all subjects
Secondary Outcomes (1)
Change in lower limb muscle quality
Change from Baseline lower limb muscle quality at 12 weeks measure in all subjects
Other Outcomes (1)
Change in mitochondrial activity
Change from Baseline mitochondrial activity at 12 weeks measure in half of the subjects
Study Arms (2)
Exercise + Placebo group
ACTIVE COMPARATOR50 subjects will receive a placebo supplementation with an exercise intervention (EX group)
Exercise + Protein group
ACTIVE COMPARATOR50 subjects will receive a protein supplementation combined with an exercise intervention (PROTEX group)
Interventions
1/2 of the subject will follow a mixed power training: 4 power exercises + 6 functional exercises combined to a placebo
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.
Eligibility Criteria
You may qualify if:
- Elderly men
- years and older
- Sedentary men
- Not obese (BMI \<30 kg/m2)
- Living in free-living community
You may not qualify if:
- Not able to follow an exercise program (doctor authorization: XAAP)
- Having Lactose intolerance
- Having Pace marker
- Having Metabolism disorder
- No weight stable since the last 6 months
- No stable medication (same dose and type since at least 6 months)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
mylene aubertin-leheudre, PhD
Université du Québec a Montréal
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 15, 2016
First Posted
January 8, 2018
Study Start
September 1, 2013
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
January 8, 2018
Record last verified: 2018-01