Muscle SynthesisNCT01317511
Protein Supply in Elderly
A study testing Protein in people with Muscle Synthesis, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Stimulating overnight muscle protein synthesis, might augment muscle hypertrophy, increase mitochondrial mass, and/or improve muscle tissue repair. The goal of this proposal will be to provide further insight into the responsiveness of the muscle protein synthetic machinery to food intake in relation to age. 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
- Muscle Synthesis
- What is being tested?
- Protein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2010to Feb 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 65 to 80 years
- Men only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Males
- Age between 65 and 80 years
- BMI < 30 kg/m2
Who cannot join
- Type 2 diabetic patients
- Use of medication
- All co morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. artrosis, arthritis, spasticity/rigidity, all neurological disorders and paralysis).
- Use of anticoagulants, blood diseases, allergy for lidocain.
- Contra indications for the use of a nasogastric tube: high risk of aspiration, gastric stasis, gastro-oesophageal reflux, upper gastrointestinal stricture, nasal injuries and base of skull fractures.
- Patients suffering from PKU (Phenylketonuria).
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Centre
Maastricht, Limburg, 6229ER
About this study
Official title: Overnight Protein Supply as a Dietary Strategy to Improve Muscle Mass in Elderly.
Stimulating overnight muscle protein synthesis, might augment muscle hypertrophy, increase mitochondrial mass, and/or improve muscle tissue repair. The goal of this proposal will be to provide further insight into the responsiveness of the muscle protein synthetic machinery to food intake in relation to age.
- Conditions
- Muscle Synthesis
- Being tested
- Protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProteinDietary supplement
Also called casein vs water
Protein drink
| Study group | Role | What they receive |
|---|---|---|
| Protein | Experimental | Protein drink Receives: Dietary Supplement: Protein |
| Placebo | Placebo comparator | water Receives: Dietary Supplement: Protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protein synthesis
Overnight protein synthesis
Measured: overnight (12 h)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2011 (estimated)
- Study startJun 2010
- Primary completionDec 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle SynthesisStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Luc van Loon, Prof., Principal investigator, Maastricht UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01317511
- Sponsor's protocol ID
- MEC 09-3-078.3
- Status last verified
- Mar 2011
- First submitted
- 16 Mar 2011
- Last updated
- 17 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Gorissen SHM, Trommelen J, Kouw IWK, Holwerda AM, Pennings B, Groen BBL, Wall BT, Churchward-Venne TA, Horstman AMH, Koopman R, Burd NA, Fuchs CJ, Dirks ML, Res PT, Senden JMG, Steijns JMJM, de Groot LCPGM, Verdijk LB, van Loon LJC. Protein Type, Protein Dose, and Age Modulate Dietary Protein Digestion and Phenylalanine Absorption Kinetics and Plasma Phenylalanine Availability in Humans. J Nutr. 2020 Aug 1;150(8):2041-2050. doi: 10.1093/jn/nxaa024.
PubMed 32069356
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overnight Protein Supply as a Dietary Strategy to Improve Muscle Mass in Elderly.
- ClinicalTrials.gov ID
- NCT01317511
- Acronym / sponsor ID
- MEC 09-3-078.3
- Conditions
- Muscle Synthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 17 Mar 2011 (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.
Stimulating overnight muscle protein synthesis, might augment muscle hypertrophy, increase mitochondrial mass, and/or improve muscle tissue repair. The goal of this proposal will be to provide further insight into the responsiveness of the muscle protein synthetic machinery to food intake in relation to age.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protein | Experimental | Dietary Supplement: ProteinProtein drink |
| Placebo | Placebo comparator | Dietary Supplement: Proteinwater |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Males
- Age between 65 and 80 years
- BMI < 30 kg/m2
Key exclusion criteria (6 listed)
- Type 2 diabetic patients
- Use of medication
- All co morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. artrosis, arthritis, spasticity/rigidity, all neurological disorders and paralysis).
- Use of anticoagulants, blood diseases, allergy for lidocain.
- Contra indications for the use of a nasogastric tube: high risk of aspiration, gastric stasis, gastro-oesophageal reflux, upper gastrointestinal stricture, nasal injuries and base of skull fractures.
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 |
|---|---|---|
| ProteinAlso: casein vs waterProtein drink | Dietary supplement | Placebo, Protein |
Primary outcome
Protein synthesis
Time frame: overnight (12 h)
Overnight protein synthesis
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 17 Mar 2011.
- Derived from this study: PubMed 32069356Gorissen SHM, Trommelen J, Kouw IWK, Holwerda AM, Pennings B, Groen BBL, Wall BT, Churchward-Venne TA, Horstman AMH, Koopman R, Burd NA, Fuchs CJ, Dirks ML, Res PT, Senden JMG, Steijns JMJM, de Groot LCPGM, Verdijk LB, van Loon LJC. Protein Type, Protein Dose, and Age Modulate Dietary Protein Digestion and Phenylalanine Absorption Kinetics and Plasma Phenylalanine Availability in Humans. J Nutr. 2020 Aug 1;150(8):2041-2050. doi: 10.1093/jn/nxaa024.
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Yeast Protein for Muscle Mass
Healthy Adult Participants
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.
Luc van Loon, Prof. principal investigator
Maastricht UMC
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 in people with Muscle Synthesis, 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 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 17 Mar 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. 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?
Protein synthesis (time frame: overnight (12 h)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01317511, which also lists 1 linked publication.
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 17 Mar 2011.