AgingNCT01239277
Combined Nutrient Intake and Muscle Protein Synthesis
A study testing protein, protein and carbohydrate and protein and leucine in people with Aging, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Dietary intervention to prevent sarcopenia in elderly people. The objective of this study is to test whether combined nutrient intake plays an important role in stimulation of the muscle protein growth in elderly people; and whether it represent effective strategies to overcome the impaired muscle protein synthesis in… Read more about this study
- Who is it for?
- Ages 70 to 85 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- protein, protein and carbohydrate and protein and leucine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2011to Jul 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 70 to 85 years
- Men only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- males
- 70-85 years or 18-30 years
- BMI < 30
Who cannot join
- Type II diabetes
- All co morbidities interacting with mobility and muscle metabolism of the lower limbs
- Use of anticoagulants
- Patients suffering from Phenylketonuria
- Participation in any regular exercise programme
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Universiteit Maastricht, Bewegingswetenschappen
Maastricht, Limburg
About this study
Dietary intervention to prevent sarcopenia in elderly people. The objective of this study is to test whether combined nutrient intake plays an important role in stimulation of the muscle protein growth in elderly people; and whether it represent effective strategies to overcome the impaired muscle protein synthesis in elderly when compared with young subjects.
- Conditions
- Aging
- Being tested
- protein, protein and carbohydrate, protein and leucine
- Keywords
- muscle, FSR, protein, carbohydrate, leucine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proteinOther
20g protein
protein and carbohydrateOther
20g protein and 20g carbohydrate
protein and leucineOther
20g protein, 2.5g leucine
| Study group | Role | What they receive |
|---|---|---|
| protein (elderly) | Experimental | Not described Receives: Other: protein |
| protein and carbohydrate (elderly) | Experimental | Not described Receives: Other: protein and carbohydrate |
| protein and carbohydrate (young) | Experimental | Not described Receives: Other: protein and carbohydrate |
| protein and leucine (elderly) | Experimental | Not described Receives: Other: protein and leucine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle protein synthesis
Muscle protein synthesis will be expressed as fractional synthetic rate (FSR) by dividing the increment in enrichment in the product, i.e. protein-bound C13phe, by the enrichment of the precursor (=plasma availability).
Measured: 6 h postprandial period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2010 (estimated)
- Study startJan 2011
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- A. de Lange, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01239277
- Sponsor's protocol ID
- MEC 10-3-080
- Status last verified
- Sep 2011
- First submitted
- 10 Nov 2010
- Last updated
- 14 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Nutrient Intake and Muscle Protein Synthesis
- ClinicalTrials.gov ID
- NCT01239277
- Acronym / sponsor ID
- MEC 10-3-080
- Conditions
- Aging
- Keywords
- muscle, FSR, protein, carbohydrate, leucine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 11 Nov 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.
Dietary intervention to prevent sarcopenia in elderly people. The objective of this study is to test whether combined nutrient intake plays an important role in stimulation of the muscle protein growth in elderly people; and whether it represent effective strategies to overcome the impaired muscle protein synthesis in elderly when compared with young subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| protein (elderly) | Experimental | Other: protein |
| protein and carbohydrate (elderly) | Experimental | Other: protein and carbohydrate |
| protein and carbohydrate (young) | Experimental | Other: protein and carbohydrate |
| protein and leucine (elderly) | Experimental | Other: protein and leucine |
Who may qualify
- Ages
- 70 to 85 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- males
- 70-85 years or 18-30 years
- BMI < 30
Key exclusion criteria (5 listed)
- Type II diabetes
- All co morbidities interacting with mobility and muscle metabolism of the lower limbs
- Use of anticoagulants
- Patients suffering from Phenylketonuria
- Participation in any regular exercise programme
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 |
|---|---|---|
| protein20g protein | Other | protein (elderly) |
| protein and carbohydrate20g protein and 20g carbohydrate | Other | protein and carbohydrate (elderly), protein and carbohydrate (young) |
| protein and leucine20g protein, 2.5g leucine | Other | protein and leucine (elderly) |
Primary outcome
Muscle protein synthesis
Time frame: 6 h postprandial period
Muscle protein synthesis will be expressed as fractional synthetic rate (FSR) by dividing the increment in enrichment in the product, i.e. protein-bound C13phe, by the enrichment of the precursor (=plasma availability).
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 14 Sep 2011.
- Information about research performed by the Maastricht Muscle Metabolism group at MUMCLink provided by the sponsor.
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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.
A. de Lange principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing protein, protein and carbohydrate and protein and leucine in people with Aging, run by Maastricht University Medical Center at 1 site in Netherlands.
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 3 inclusion and 5 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 14 Sep 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 Netherlands. 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: 6 h postprandial period). 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 14 Sep 2011.