SarcopeniaNDCNCT01062711
Dose Response of Whey and Soy Protein Ingestion With and Without Resistance Exercise in Elderly Men
A study testing Whey or soy protein in people with Sarcopenia, run by McMaster University at 1 site in Canada.
Trial summary
When we age, we lose muscle. It is not exactly clear why this happens, but we do know that this muscle loss can increase health risks and lead to health problems. Lifting weights (i.e. Read more about this study
- Who is it for?
- Ages 60 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Whey or soy protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2008to May 2011
- 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 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male
- Aged 60 to 80 years old
- Non-smoker
- Generally healthy and can tolerate the resistance exercise and protein drink
Who cannot join
- Allergies to whey, casein or soy
- Health problems such as: heart disease, rheumatoid arthritis of the knee joint, diabetes, poor lung function, uncontrolled hypertension, or any health conditions that might put participants at risks for this study
- Failed clearance for exercise participation by their medical doctor
- Failed an exercise stress test
- Taking metformin and/or other medications for the control of blood glucose even though one might not be classified as diabetic
- Taking prescribed blood thinners such as warfarin and heparin but excluding aspirin
- Taking medications for lung and kidney conditions but excluding medication for asthma that is under control
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Responses of Muscle and Whole-body Protein Turnover to Ingestion of Differing Doses of Whey and Soy Protein With and Without Resistance Exercise in Elderly Men
When we age, we lose muscle. It is not exactly clear why this happens, but we do know that this muscle loss can increase health risks and lead to health problems. Lifting weights (i.e. performing resistance exercise) and proper nutrition, in particular eating enough high quality protein, can help slow the loss of muscle mass or potentially even reverse it. Protein and resistance exercise are thought to do this by stimulating your muscle to make more proteins and/or potentially by slowing down the rate at which your body breaks proteins down. Whey protein is a high quality protein isolated from milk and is known to stimulate new protein synthesis for all proteins in your body. However, to date, the effect that whey protein has on muscle protein synthesis, particularly in the elderly has yet to be determined. Thus the purposes of this study are: 1) to determine if whey is an effective source of protein that will stimulate muscle protein synthesis in the elderly, similar to what we have previously seen in young persons; 2) to determine the smallest amount of whey protein to consume to maximally stimulate your muscle to make new proteins; 3) to see if performing resistance exercise will augment the increase in new muscle protein synthesis with whey consumption; and 4) to try and found out if whey is more effective than soy protein in stimulating new muscle protein synthesis and suppressing muscle protein breakdown in the elderly, similar to what we have previously seen in young persons
- Conditions
- Sarcopenia
- Being tested
- Whey or soy protein
- Keywords
- sarcopenia, muscle, protein, muscle protein synthesis, muscle protein breakdown, whey, soy, casein, dose response, resistance exercise, unilateral, knee extension, whole body protein
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey or soy proteinDietary supplement
Whey and casein are isolated milk proteins
| Study group | Role | What they receive |
|---|---|---|
| Control group 0 g protein | Other | Control group in which a placebo drink containing no protein is given following unilateral knee extension exercise Receives: Dietary Supplement: Whey or soy protein |
| 10g whey | Experimental | 10g whey protein given following unilateral knee extension exercise Receives: Dietary Supplement: Whey or soy protein |
| 20g whey | Experimental | 20g whey protein given following unilateral knee extension exercise Receives: Dietary Supplement: Whey or soy protein |
| 30g whey | Experimental | 30g whey protein given following unilateral knee extension exercise Receives: Dietary Supplement: Whey or soy protein |
| 40g whey | Experimental | 40g whey protein given following unilateral knee extension exercise Receives: Dietary Supplement: Whey or soy protein |
| 20g soy | Experimental | 20g soy protein given following unilateral knee extension exercise Receives: Dietary Supplement: Whey or soy protein |
| 40g soy | Experimental | 40g soy protein given following unilateral knee extension exercise Receives: Dietary Supplement: Whey or soy protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle protein synthesis
Measured: Acute within the day
whole body amino acid oxidation
Measured: acute within the day
Secondary outcomes (3)
muscle protein breakdown
Measured: Acute within the day
serum insulin
Measured: acute within the day
plasma amino acid concentrations
Measured: acute within the day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2010 (estimated)
- Study startJul 2008
- Primary completionDec 2010
- Study completionMay 2011
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 McMaster UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- National Dairy Council
- Investigators
- Stuart Phillips, Ph.D., Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01062711
- Sponsor's protocol ID
- DMI 1484
- Acronym
- NDC
- Status last verified
- Jul 2011
- First submitted
- 3 Feb 2010
- Last updated
- 20 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Responses of Muscle and Whole-body Protein Turnover to Ingestion of Differing Doses of Whey and Soy Protein With and Without Resistance Exercise in Elderly Men
- ClinicalTrials.gov ID
- NCT01062711
- Acronym / sponsor ID
- NDC / DMI 1484
- Conditions
- Sarcopenia
- Keywords
- sarcopenia, muscle, protein, muscle protein synthesis, muscle protein breakdown, whey, soy, casein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- National Dairy Council
- Study start
- Jul 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 4 Feb 2010 (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.
When we age, we lose muscle. It is not exactly clear why this happens, but we do know that this muscle loss can increase health risks and lead to health problems. Lifting weights (i.e. performing resistance exercise) and proper nutrition, in particular eating enough high quality protein, can help slow the loss of muscle mass or potentially even reverse it. Protein and resistance exercise are thought to do this by stimulating your muscle to make more proteins and/or potentially by slowing down the rate at which your body breaks proteins down. Whey protein is a high quality protein isolated from milk and is known to stimulate new protein synthesis for all proteins in your body. However, to date, the effect that whey protein has on muscle protein synthesis, particularly in the elderly has yet to be determined. Thus the purposes of this study are: 1) to determine if whey is an effective source of protein that will stimulate muscle protein synthesis in the elderly, similar to what we have previously seen in young persons; 2) to determine the smallest amount of whey protein to consume to maximally stimulate your muscle to make new proteins; 3) to see if performing resistance exercise will augment the increase in new muscle protein synthesis with whey consumption; and 4) to try and found out if whey is more effective than soy protein in stimulating new muscle protein synthesis and suppressing muscle protein breakdown in the elderly, similar to what we have previously seen in young persons
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Control group 0 g protein | Other | Dietary Supplement: Whey or soy proteinControl group in which a placebo drink containing no protein is given following unilateral knee extension exercise |
| 10g whey | Experimental | Dietary Supplement: Whey or soy protein10g whey protein given following unilateral knee extension exercise |
| 20g whey | Experimental | Dietary Supplement: Whey or soy protein20g whey protein given following unilateral knee extension exercise |
| 30g whey | Experimental | Dietary Supplement: Whey or soy protein30g whey protein given following unilateral knee extension exercise |
| 40g whey | Experimental | Dietary Supplement: Whey or soy protein40g whey protein given following unilateral knee extension exercise |
| 20g soy | Experimental | Dietary Supplement: Whey or soy protein20g soy protein given following unilateral knee extension exercise |
| 40g soy | Experimental | Dietary Supplement: Whey or soy protein40g soy protein given following unilateral knee extension exercise |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male
- Aged 60 to 80 years old
- Non-smoker
- Generally healthy and can tolerate the resistance exercise and protein drink
Key exclusion criteria (7 listed)
- Allergies to whey, casein or soy
- Health problems such as: heart disease, rheumatoid arthritis of the knee joint, diabetes, poor lung function, uncontrolled hypertension, or any health conditions that might put participants at risks for this study
- Failed clearance for exercise participation by their medical doctor
- Failed an exercise stress test
- Taking metformin and/or other medications for the control of blood glucose even though one might not be classified as diabetic
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 |
|---|---|---|
| Whey or soy proteinWhey and casein are isolated milk proteins | Dietary supplement | 10g whey, 20g soy, 20g whey, 30g whey, 40g soy, 40g whey, Control group 0 g protein |
Primary outcome
Muscle protein synthesis
Time frame: Acute within the day
whole body amino acid oxidation
Time frame: acute within the day
3 secondary outcomes
muscle protein breakdown
Time frame: Acute within the day
serum insulin
Time frame: acute within the day
plasma amino acid concentrations
Time frame: acute within the day
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 20 Jul 2011.
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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.
Stuart Phillips, Ph.D. principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey or soy protein in people with Sarcopenia, run by McMaster University 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 4 inclusion and 7 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 20 Jul 2011. 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. 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 protein synthesis (time frame: Acute within the day). The study lists 2 primary outcomes in all. 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 20 Jul 2011; AzTrials last refreshed its copy on 7 Nov 2026.