Protein Supplementation and Mixed Power Training on Muscle Function and Functional Capacities in Elderly Men (PROMU)

January 2, 2018 updated by: Mylène Aubertin-Leheudre, Université du Québec a Montréal

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Recently, 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.

Due to this recent finding, it has been proposed that muscle power training would be the best exercise intervention to prevent the loss of mobility.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Elderly men
  • 60 years and older
  • Sedentary men
  • Not obese (BMI <30 kg/m2)
  • Living in free-living community

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Exercise + Placebo group
50 subjects will receive a placebo supplementation with an exercise intervention (EX group)
Other: Exercise + Placebo group
1/2 of the subject will follow a mixed power training: 4 power exercises + 6 functional exercises combined to a placebo
Active Comparator: Exercise + Protein group
50 subjects will receive a protein supplementation combined with an exercise intervention (PROTEX group)
Other: Exercise + Protein group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in walking speed
Time Frame: Change from Baseline walking speed at 12 weeks measure in all subjects
evaluate using the 4m- normal walking speed (m/sec)
Change from Baseline walking speed at 12 weeks measure in all subjects

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in lower limb muscle quality
Time Frame: Change from Baseline lower limb muscle quality at 12 weeks measure in all subjects
Knee extension muscle strength (isometric (N)/ lower limb muscle mass (kg))
Change from Baseline lower limb muscle quality at 12 weeks measure in all subjects

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in mitochondrial activity
Time Frame: Change from Baseline mitochondrial activity at 12 weeks measure in half of the subjects
citrate synthase activity (unit: percent)
Change from Baseline mitochondrial activity at 12 weeks measure in half of the subjects

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université du Québec a Montréal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

December 15, 2016

First Submitted That Met QC Criteria

January 2, 2018

First Posted (Actual)

January 8, 2018

Study Record Updates

Last Update Posted (Actual)

January 8, 2018

Last Update Submitted That Met QC Criteria

January 2, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UQAM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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