ClinicalTrials.gg
CompletedNCT03393650PROMUUpdated Jan 8, 2018

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

An interventional study of Exercise + Placebo group and Exercise + Protein group in Dynapenia, Aging and Physical Impairment, sponsored by Université du Québec a Montréal. Completed. Open to male participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-08.

Sponsored by Université du Québec a Montréal · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
60 Years and older
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Dynapenia
  • Aging
  • Physical Impairment

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Keywords

  • exercise
  • protein
  • muscle function
  • aging
03

In context

Motor Activity

9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.

This study's enrollment of 100 is above the median of 60 across 8,388 interventional studies indexed under Motor Activity.

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Lead sponsor

Université du Québec a Montréal is the lead sponsor of 19 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
100 participants (actual)

Study arms

  • Active comparator
    Exercise + Placebo group

    50 subjects will receive a placebo supplementation with an exercise intervention (EX group)

    Other: Exercise + Placebo group

  • Active comparator
    Exercise + Protein group

    50 subjects will receive a protein supplementation combined with an exercise intervention (PROTEX group)

    Other: Exercise + Protein group

Interventions

  • OtherExercise + Placebo group

    1/2 of the subject will follow a mixed power training: 4 power exercises + 6 functional exercises combined to a placebo

  • OtherExercise + 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.

06

What researchers measure

Primary outcomes

  1. Change in walking speed

    evaluate using the 4m- normal walking speed (m/sec)

    Time frame: Change from Baseline walking speed at 12 weeks measure in all subjects

Secondary outcomes

  1. Change in lower limb muscle quality

    Knee extension muscle strength (isometric (N)/ lower limb muscle mass (kg))

    Time frame: Change from Baseline lower limb muscle quality at 12 weeks measure in all subjects

Other outcomes

  1. Change in mitochondrial activity

    citrate synthase activity (unit: percent)

    Time frame: Change from Baseline mitochondrial activity at 12 weeks measure in half of the subjects

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Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2013, a primary completion of Dec 2015 and a completion of Dec 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 15, 2016
First posted
Jan 8, 2018
Start
Sep 2013
Primary completionActual
Dec 2015
CompletionActual
Dec 2015
Last update
Jan 8, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 8, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03393650
Lead sponsor
Université du Québec a Montréal
Responsible party
Mylène Aubertin-Leheudre (Professor, Université du Québec a Montréal) — Principal investigator
First posted
Jan 8, 2018
Start date
Sep 2013
Primary completion
Dec 2015
Completion
Dec 2015
Last update
Jan 8, 2018

Study contacts

mylene aubertin-leheudre, PhD
principal investigator · Université du Québec a Montréal

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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