Healthy Elderly MuscleNCT02315391
Protein Nutrition for Muscle Hypertrophy in Older Adults
A study testing isolated whey protein, micellar whey protein and glycine in people with Healthy Elderly Muscle and Anabolically Resistant Elderly Muscle, run by Société des Produits Nestlé (SPN).
Trial summary
The primary objective is to determine the effect of reduced activity on the stimulation of myofibrillar FSR with protein feeding in the elderly. Read more about this study
- Who is it for?
- Ages 65 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Elderly Muscle, Anabolically Resistant Elderly Muscle
- What is being tested?
- isolated whey protein, micellar whey protein and glycine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Dec 2013
- 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 80 years
- Men only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Must habitually complete a minimum of 5000 steps per day
- Having obtained informed consent
- Non-obese
- Non-smoker
Who cannot join
- Aged >80 years
- Inability to comply with study procedures
- Currently participating or having participated in another infusion trial during last 12 months
- Any acute or chronic llness
- History of neuromuscular problems
- Medications known to affect protein metabolism
- Individuals who complete fewer than 5000 steps per day
- Individuals who have metal implants
About this study
Official title: Efficacy of Isolated Whey and Micellar Whey Protein (+/- Citrulline) to Stimulate Protein Synthesis in 'Healthy' and 'Anabolically Resistant' Elderly Muscle
The primary objective is to determine the effect of reduced activity on the stimulation of myofibrillar FSR with protein feeding in the elderly.
Read the detailed description
The primary objective is to determine the effect of reduced activity on the stimulation of myofibrillar FSR with protein feeding in the elderly
- Being tested
- isolated whey protein, micellar whey protein, glycine, citrulline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isolated whey proteinDietary supplement
isolated whey protein
micellar whey proteinDietary supplement
micellar whey protein
glycineDietary supplement
glycine
citrullineDietary supplement
citrulline
| Study group | Role | What they receive |
|---|---|---|
| 20g isolated whey protein + 30g carb, 8,5g fat, 15g glycine | Experimental | 20g isolated whey protein + 30g carb, 8,5g fat, 15g glycine Receives: Dietary Supplement: isolated whey protein; Dietary Supplement: glycine |
| 20g micellar whey protein + 30g carb, 8.5g fat, 15g glycine | Experimental | 20g micellar whey protein + 30g carb, 8.5g fat, 15g glycine Receives: Dietary Supplement: micellar whey protein; Dietary Supplement: glycine |
| 20g micellar whey protein + 30g carb, 8.5g fat, 5g citrulline | Experimental | 20g micellar whey protein + 30g carb, 8.5g fat, 5g citrulline Receives: Dietary Supplement: micellar whey protein; Dietary Supplement: citrulline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in myofibrillar fractional synthetic rate (FSR)
Measured: one day and 2 weeks
Secondary outcomes (2)
change in non-myofibrillar fractional synthetic rate (FSR)
Measured: baseline and one day of feeding
Capillary dilatation and blood flow
Determine if inactivity reduces the feeding-induced increase in capillary dilation and nutrient delivery and whether citrulline rescues this in "resistant" muscle or augments it in the "healthy" muscle as measured by Definity infusion and contrast enhanced ultrasound (CEUS)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2014 (estimated)
- Study startSep 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Elderly MuscleStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stuart Philips, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02315391
- Sponsor's protocol ID
- 11.06.NRC
- Status last verified
- Nov 2014
- First submitted
- 12 Nov 2014
- Last updated
- 18 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Isolated Whey and Micellar Whey Protein (+/- Citrulline) to Stimulate Protein Synthesis in 'Healthy' and 'Anabolically Resistant' Elderly Muscle
- ClinicalTrials.gov ID
- NCT02315391
- Acronym / sponsor ID
- 11.06.NRC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 11 Dec 2014 (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.
The primary objective is to determine the effect of reduced activity on the stimulation of myofibrillar FSR with protein feeding in the elderly.
Detailed description
The primary objective is to determine the effect of reduced activity on the stimulation of myofibrillar FSR with protein feeding in the elderly
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 20g isolated whey protein + 30g carb, 8,5g fat, 15g glycine | Experimental | Dietary Supplement: isolated whey protein, Dietary Supplement: glycine20g isolated whey protein + 30g carb, 8,5g fat, 15g glycine |
| 20g micellar whey protein + 30g carb, 8.5g fat, 15g glycine | Experimental | Dietary Supplement: micellar whey protein, Dietary Supplement: glycine20g micellar whey protein + 30g carb, 8.5g fat, 15g glycine |
| 20g micellar whey protein + 30g carb, 8.5g fat, 5g citrulline | Experimental | Dietary Supplement: micellar whey protein, Dietary Supplement: citrulline20g micellar whey protein + 30g carb, 8.5g fat, 5g citrulline |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Must habitually complete a minimum of 5000 steps per day
- Having obtained informed consent
- Non-obese
- Non-smoker
Key exclusion criteria (8 listed)
- Aged >80 years
- Inability to comply with study procedures
- Currently participating or having participated in another infusion trial during last 12 months
- Any acute or chronic llness
- History of neuromuscular problems
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 |
|---|---|---|
| isolated whey proteinisolated whey protein | Dietary supplement | 20g isolated whey protein + 30g carb, 8,5g fat, 15g glycine |
| micellar whey proteinmicellar whey protein | Dietary supplement | 20g micellar whey protein + 30g carb, 8.5g fat, 15g glycine, 20g micellar whey protein + 30g carb, 8.5g fat, 5g citrulline |
| glycineglycine | Dietary supplement | 20g isolated whey protein + 30g carb, 8,5g fat, 15g glycine, 20g micellar whey protein + 30g carb, 8.5g fat, 15g glycine |
| citrullinecitrulline | Dietary supplement | 20g micellar whey protein + 30g carb, 8.5g fat, 5g citrulline |
Primary outcome
Change in myofibrillar fractional synthetic rate (FSR)
Time frame: one day and 2 weeks
2 secondary outcomes
change in non-myofibrillar fractional synthetic rate (FSR)
Time frame: baseline and one day of feeding
Capillary dilatation and blood flow
Time frame: 2 weeks
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 18 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.
Stuart Philips, PhD principal investigator
McMaster University
Questions about this trial
What is this clinical trial studying?
A study testing isolated whey protein, micellar whey protein and glycine in people with Healthy Elderly Muscle and Anabolically Resistant Elderly Muscle, run by Société des Produits Nestlé (SPN).
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 8 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 18 Dec 2014. 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 myofibrillar fractional synthetic rate (FSR) (time frame: one day and 2 weeks). 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 18 Dec 2014.