SarcopeniaPRONCT01883674
Milk and Milk-produce to Counteract the Loss of Muscle Mass and Function in Exercising Older Adults.
A study testing Resistance training in people with Sarcopenia, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
This project evaluates the use of different types of proteins from various food sources after an exercise session, on muscle mass and physical capacity in aged sarcopenic men (who have low muscle mass). Read more about this study
- Who is it for?
- Ages 65 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Resistance training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteCanada
- Study dates
- May 2012to Dec 2014
- 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 65 to 75 years
- Men only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 65-75 years
- francophone or understanding French
- muscle mass index < 10.75 kg/m2 (Janssen et al, 2004)
- body mass index <30kg/m²
- weight stable (< 2 kg) for 6 mo
- no resistance exercise for 3 years
- controlled blood pressure for at least 6 months
Who cannot join
- major physical disability
- medical treatment influencing metabolism
- statin treatment
- diagnosis or any sign of kidney disease
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre de recherche sur le vieillissement
Sherbrooke, Quebec, J1H 4C4
About this study
This project evaluates the use of different types of proteins from various food sources after an exercise session, on muscle mass and physical capacity in aged sarcopenic men (who have low muscle mass). Specifically, researchers want to:
- Examine the efficiency of protein intake after exercise on muscle mass and physical abilities;
- Examine the impact of exercise and proteins on blood lipids (LDL cholesterol, HDL cholesterol, total cholesterol and triglycerides);
- Examine the impact of exercise and proteins on liver enzymes;
- Examine the impact of exercise and proteins on a hormone that controls hunger;
- Evaluate the program's impact on the ability of the body to produce energy.
Read more
All participants are exercising (resistance training) and ingest one of the 3 different sources of proteins, immediately after training:
- Milk proteins (from milk beverage)
- Essential amino acids (added to a soya beverage)
- No protein (rice beverage - control group)
Our hypothesis is that proteins from milk will induce a gain in muscle mass and physical function equivalent to the essential amino acids (EAA). We anticipate that both milk proteins and EAA will be both superior to control group.
This would represent an interesting finding since milk is more accessible, palatable and cheaper than essential amino acids commercial mix.
- Conditions
- Sarcopenia
- Being tested
- Resistance training
- Keywords
- Sarcopenia, Physical capacity, Muscle force, Muscle quality, Milk proteins, Essential amino acids, Proteins, Resistance training, Exercise
- Medical subject headings
- Sarcopenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance trainingOther
All group will exercise 3x/week. Each session of resistance training will last 60min. and will target main muscular groups.
| Study group | Role | What they receive |
|---|---|---|
| Milk proteins | Experimental | This group will do a resistance training + milk proteins (milk beverage) Receives: Other: Resistance training |
| Essential amino acids (add to soya bvg) | Experimental | This group will do a resistance training + essential amino acids (added to soya beverage) Receives: Other: Resistance training |
| No protein (control) | Placebo comparator | This group will do a resistance training + ingestion of the control beverage (no protein, rice beverage) Receives: Other: Resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle mass
Measured: At baseline and post intervention (17th week)
Secondary outcomes (6)
Relative strength
Measured: At baseline and post intervention (17th week)
Blood markers of inflammation
Plasmatic IL-6 anf TNF-alpha
Measured: At baseline and post intervention (17th week)
Plasma Lipid profile
Apolipoproteins (Apo-AI, Apo-AII, Apo-B); Total cholesterol, HDL, LDL and triglycerides.
Measured: At baseline and post intervention (17th week)
Plasma creatinine
Blood marker on renal function will be assessed to ensure the safety of the supplementation of protein intake on renal function in sarcopenic men.
Measured: At baseline, mid (8th week) and post intervention (17th week)
Blood markers of fatty liver
Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gamma-glutamyltransferase (GGT) and Alkaline phosphatase (ALP).
Measured: At baseline and post intervention (17th week)
extracellular HSP72
Measured: At baseline and post intervention (17th week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startMay 2012
- Primary completionApr 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Dairy Farmers of Canada
- Responsible party
- Sponsor
- Investigators
- Isabelle J. Dionne, Ph.D., Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01883674
- Sponsor's protocol ID
- PLC-021742
- Acronym
- PRO
- Status last verified
- Dec 2014
- First submitted
- 7 Feb 2013
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Milk and Milk-produce to Counteract the Loss of Muscle Mass and Function in Exercising Older Adults.
- ClinicalTrials.gov ID
- NCT01883674
- Acronym / sponsor ID
- PRO / PLC-021742
- Conditions
- Sarcopenia
- Keywords
- Sarcopenia, Physical capacity, Muscle force, Muscle quality, Milk proteins, Essential amino acids, Proteins, Resistance training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Dairy Farmers of Canada
- Study start
- May 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 21 Jun 2013 (estimated)
- 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.
This project evaluates the use of different types of proteins from various food sources after an exercise session, on muscle mass and physical capacity in aged sarcopenic men (who have low muscle mass). Specifically, researchers want to:
- Examine the efficiency of protein intake after exercise on muscle mass and physical abilities;
- Examine the impact of exercise and proteins on blood lipids (LDL cholesterol, HDL cholesterol, total cholesterol and triglycerides);
- Examine the impact of exercise and proteins on liver enzymes;
- Examine the impact of exercise and proteins on a hormone that controls hunger;
- Evaluate the program's impact on the ability of the body to produce energy.
All participants are exercising (resistance training) and ingest one of the 3 different sources of proteins, immediately after training:
- Milk proteins (from milk beverage)
- Essential amino acids (added to a soya beverage)
- No protein (rice beverage - control group)
Our hypothesis is that proteins from milk will induce a gain in muscle mass and physical function equivalent to the essential amino acids (EAA). We anticipate that both milk proteins and EAA will be both superior to control group.
This would represent an interesting finding since milk is more accessible, palatable and cheaper than essential amino acids commercial mix.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Milk proteins | Experimental | Other: Resistance trainingThis group will do a resistance training + milk proteins (milk beverage) |
| Essential amino acids (add to soya bvg) | Experimental | Other: Resistance trainingThis group will do a resistance training + essential amino acids (added to soya beverage) |
| No protein (control) | Placebo comparator | Other: Resistance trainingThis group will do a resistance training + ingestion of the control beverage (no protein, rice beverage) |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 65-75 years
- francophone or understanding French
- muscle mass index < 10.75 kg/m2 (Janssen et al, 2004)
- body mass index <30kg/m²
- weight stable (< 2 kg) for 6 mo
Key exclusion criteria (4 listed)
- major physical disability
- medical treatment influencing metabolism
- statin treatment
- diagnosis or any sign of kidney disease
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 |
|---|---|---|
| Resistance trainingAll group will exercise 3x/week. Each session of resistance training will last 60min. and will target main muscular groups. | Other | Essential amino acids (add to soya bvg), Milk proteins, No protein (control) |
Primary outcome
Muscle mass
Time frame: At baseline and post intervention (17th week)
6 secondary outcomes
Relative strength
Time frame: At baseline and post intervention (17th week)
Blood markers of inflammation
Time frame: At baseline and post intervention (17th week)
Plasma Lipid profile
Time frame: At baseline and post intervention (17th week)
Plasma creatinine
Time frame: At baseline, mid (8th week) and post intervention (17th week)
Blood markers of fatty liver
Time frame: At baseline and post intervention (17th week)
extracellular HSP72
Time frame: At baseline and post intervention (17th week)
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 3 Dec 2014.
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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.
Isabelle J. Dionne, Ph.D. principal investigator
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance training in people with Sarcopenia, run by Université de Sherbrooke at 1 site in Canada.
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 7 inclusion and 4 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 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Muscle mass (time frame: At baseline and post intervention (17th week)). 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 3 Dec 2014.