DynapeniaPROMUNCT03393650
Protein Supplementation and Mixed Power Training on Muscle Function and Functional Capacities in Elderly Men
A study testing Exercise + Protein group in people with Dynapenia and Aging, run by Université du Québec a Montréal.
Trial 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 more about this study
- Who is it for?
- Ages 60 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dynapenia, Aging, Physical Impairment
- What is being tested?
- Exercise + Protein group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elderly men
- 60 years and older
- Sedentary men
- Not obese (BMI <30 kg/m2)
- Living in free-living community
Who cannot join
- 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)
About this study
Official title: 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.
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.
- Conditions
- Dynapenia, Aging, Physical Impairment
- Being tested
- Exercise + Placebo group, Exercise + Protein group
- Keywords
- exercise, protein, muscle function, aging
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise + Placebo groupOther
1/2 of the subject will follow a mixed power training: 4 power exercises + 6 functional exercises combined to a placebo
Exercise + Protein groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise + Placebo group | Active comparator | 50 subjects will receive a placebo supplementation with an exercise intervention (EX group) Receives: Other: Exercise + Placebo group |
| Exercise + Protein group | Active comparator | 50 subjects will receive a protein supplementation combined with an exercise intervention (PROTEX group) Receives: Other: Exercise + Protein group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in walking speed
evaluate using the 4m- normal walking speed (m/sec)
Measured: 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))
Measured: Change from Baseline lower limb muscle quality at 12 weeks measure in all subjects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study startSep 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DynapeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université du Québec a Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mylène Aubertin-Leheudre, Université du Québec a Montréal
- Investigators
- mylene aubertin-leheudre, PhD, Principal investigator, Université du Québec a Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03393650
- Sponsor's protocol ID
- UQAM
- Acronym
- PROMU
- Status last verified
- Jan 2018
- First submitted
- 15 Dec 2016
- Last updated
- 8 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03393650
- Acronym / sponsor ID
- PROMU / UQAM
- Conditions
- Dynapenia, Aging, Physical Impairment
- Keywords
- exercise, protein, muscle function, aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Université du Québec a MontréalUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 8 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise + Placebo group | Active comparator | Other: Exercise + Placebo group50 subjects will receive a placebo supplementation with an exercise intervention (EX group) |
| Exercise + Protein group | Active comparator | Other: Exercise + Protein group50 subjects will receive a protein supplementation combined with an exercise intervention (PROTEX group) |
Who may qualify
- Ages
- 60 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Elderly men
- 60 years and older
- Sedentary men
- Not obese (BMI <30 kg/m2)
- Living in free-living community
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise + Placebo group1/2 of the subject will follow a mixed power training: 4 power exercises + 6 functional exercises combined to a placebo | Other | Exercise + Placebo group |
| Exercise + Protein group1/2 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. | Other | Exercise + Protein group |
Primary outcome
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)
1 secondary outcome
Change in lower limb muscle quality
Time frame: Change from Baseline lower limb muscle quality at 12 weeks measure in all subjects
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Dynapenia
Not yet recruitingObservational study
Investigation of the Prevalence of Sarcopenia and Dynapenia According to Disease Stage in Patients With Multiple Sclerosis and Evaluation of the Relationship Between Sarcopenia Severity and Clinical and Functional Parameters
Multiple Sclerosis, Sarcopenia
RecruitingObservational study
Patients With Type 2 Diabetes
Diabetes Mellitus Type 2
Not yet recruiting
Blood Flow Restriction Parameters and Lower Limb Function in Older Adults With Dynapenia
Dynapenia
Not yet recruiting
Effectiveness of Whole Body Vibration on Health Outcomes in Older Adults With Dynapenic Abdominal Obesity
Dynapenia, Abdominal Obesity
Enrolling by invitation
Reduction in Resistance Training Volume and Neuromuscular Adaptations in Older Adults
Sarcopenia in Elderly, Dynapenia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mylene aubertin-leheudre, PhD principal investigator
Université du Québec a Montréal
Questions about this trial
What is this clinical trial studying?
A study testing Exercise + Protein group in people with Dynapenia and Aging, run by Université du Québec a Montréal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in walking speed (time frame: Change from Baseline walking speed at 12 weeks measure in all subjects). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2018.