SarcopeniaES-PRONCT01615276
Neuromuscular Electrical Stimulation (NMES) and Muscle Protein Accretion (ES-PRO)
A study testing Enraf Nonius Tensmed S84 for Neuromuscular electrical stimulation (NMES) and No Enraf Nonius Tensmed S84 for Neuromuscular electrical stimulation (NMES) NMES in people with Sarcopenia, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
In the present study, the effect of a bolus of intrinsically labeled milk directly after one-legged NMES will be studied. Read more about this study
- Who is it for?
- Ages 65 to 85 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Enraf Nonius Tensmed S84 for Neuromuscular electrical stimulation (NMES) and No Enraf Nonius Tensmed S84 for Neuromuscular electrical stimulation (NMES) NMES
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2012to Jan 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 85 years
- Men only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Male
- Age 65 - 85 years
- 18.5 < BMI < 30 kg∙m2
Who cannot join
- Type II diabetes
- All co morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. arthrosis, arthritis, spasticity/rigidity, all neurological disorders, paralysis, hip/knee surgery).
- Use of anticoagulants, blood diseases, allergy for lidocaine
- Use of NSAIDs and acetylsalicylic acid
- Patients suffering from PKU (Phenylketonuria)
- Presence of implantable cardioverter defibrillator and/or pacemaker
- Performed regular resistance type exercise in the past 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Neuromuscular Electrical Stimulation on Post-prandial Muscle Protein Accretion in Healthy Elderly Men
In the present study, the effect of a bolus of intrinsically labeled milk directly after one-legged NMES will be studied.
- Conditions
- Sarcopenia
- Being tested
- Enraf Nonius Tensmed S84 for Neuromuscular electrical stimulation (NMES), No Enraf Nonius Tensmed S84 for Neuromuscular electrical stimulation (NMES) NMES
- Keywords
- Neuromuscular Electrical Stimulation, Ageing, Protein ingestion
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enraf Nonius Tensmed S84 for Neuromuscular electrical stimulation (NMES)Device
One our of one-legged neuromuscular electrical stimulation (NMES)
No Enraf Nonius Tensmed S84 for Neuromuscular electrical stimulation (NMES) NMESDevice
No neuromuscular electrical stimulation (NMES) will be applied in the control leg
| Study group | Role | What they receive |
|---|---|---|
| Protein ingestion | Placebo comparator | Protein ingestion directly after the contralateral leg received NMES Receives: Device: No Enraf Nonius Tensmed S84 for Neuromuscular electrical stimulation (NMES) NMES |
| Protein ingestion after NMES | Experimental | Ingestion of intrinsically labeled protein, directly after one hour of Neuromuscular electrical stimulation (NMES) Receives: Device: Enraf Nonius Tensmed S84 for Neuromuscular electrical stimulation (NMES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tracer enrichment in the muscle biopsy
Measured: 4 hours after protein ingestion
Secondary outcomes (1)
Fractional synthetic rate (FSR)
Measured: 0-4 hours after protein ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2012 (estimated)
- Study startOct 2012
- Primary completionJan 2013
- Study completionJan 2013
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 SarcopeniaStudies 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
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luc JC van Loon, PhD, Principal investigator, Maastricht UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01615276
- Sponsor's protocol ID
- MEC 12-3-020
- Acronym
- ES-PRO
- Status last verified
- May 2013
- First submitted
- 30 May 2012
- Last updated
- 31 May 2013
- 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 31 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Neuromuscular Electrical Stimulation on Post-prandial Muscle Protein Accretion in Healthy Elderly Men
- ClinicalTrials.gov ID
- NCT01615276
- Acronym / sponsor ID
- ES-PRO / MEC 12-3-020
- Conditions
- Sarcopenia
- Keywords
- Neuromuscular Electrical Stimulation, Ageing, Protein ingestion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 8 Jun 2012 (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.
In the present study, the effect of a bolus of intrinsically labeled milk directly after one-legged NMES will be studied.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protein ingestion | Placebo comparator | Device: No Enraf Nonius Tensmed S84 for Neuromuscular electrical stimulation (NMES) NMESProtein ingestion directly after the contralateral leg received NMES |
| Protein ingestion after NMES | Experimental | Device: Enraf Nonius Tensmed S84 for Neuromuscular electrical stimulation (NMES)Ingestion of intrinsically labeled protein, directly after one hour of Neuromuscular electrical stimulation (NMES) |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Male
- Age 65 - 85 years
- 18.5 < BMI < 30 kg∙m2
Key exclusion criteria (7 listed)
- Type II diabetes
- All co morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. arthrosis, arthritis, spasticity/rigidity, all neurological disorders, paralysis, hip/knee surgery).
- Use of anticoagulants, blood diseases, allergy for lidocaine
- Use of NSAIDs and acetylsalicylic acid
- Patients suffering from PKU (Phenylketonuria)
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 |
|---|---|---|
| Enraf Nonius Tensmed S84 for Neuromuscular electrical stimulation (NMES)One our of one-legged neuromuscular electrical stimulation (NMES) | Device | Protein ingestion after NMES |
| No Enraf Nonius Tensmed S84 for Neuromuscular electrical stimulation (NMES) NMESNo neuromuscular electrical stimulation (NMES) will be applied in the control leg | Device | Protein ingestion |
Primary outcome
Tracer enrichment in the muscle biopsy
Time frame: 4 hours after protein ingestion
1 secondary outcome
Fractional synthetic rate (FSR)
Time frame: 0-4 hours after protein ingestion
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 31 May 2013.
- 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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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 JC van Loon, PhD 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 Enraf Nonius Tensmed S84 for Neuromuscular electrical stimulation (NMES) and No Enraf Nonius Tensmed S84 for Neuromuscular electrical stimulation (NMES) NMES in people with Sarcopenia, 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 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 31 May 2013. 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?
Tracer enrichment in the muscle biopsy (time frame: 4 hours after protein ingestion). 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 NCT01615276, 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 31 May 2013.