SarcopeniaESPRO2NCT02253329
NMES During the Day and Prior to Sleep
A study testing Dietary protein plus NMES during the day and Dietary protein plus NMES prior to sleep 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 (Neuromuscular Electrical Stimulation) will be studied under two conditions: during the day and prior to sleep 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?
- Dietary protein plus NMES during the day and Dietary protein plus NMES prior to sleep
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2015to May 2015
- 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
- Age 65-85 years
- Male
- 18.5 ≤ BMI ≤ 30.0
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 (non-steroidal anti-inflammatory drugs) and acetylsalicylic acid
- Patients suffering from PKU (Phenylketonuria)
- Presence of implantable cardioverter defibrillator and/or pacemaker
Show all 9Show fewer
- Performed regular resistance type exercise in the past 6 months
- Use of any tools to assist during walking (cane/ crutches/ walker)
- (Partial) foot/ leg amputation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Neuromuscular Electrical Stimulation on Post-prandial Protein Accretion During the Day and Prior to Sleep
In the present study, the effect of a bolus of intrinsically labeled milk directly after one-legged NMES (Neuromuscular Electrical Stimulation) will be studied under two conditions: during the day and prior to sleep
Read the detailed description
In the present study, the effect of a bolus of intrinsically labeled milk directly after an hour of one-legged NMES (Neuromuscular Electrical Stimulation) will be studied under two conditions: during the day and immediately prior to sleep
- Conditions
- Sarcopenia
- Being tested
- Dietary protein plus NMES during the day, Dietary protein plus NMES prior to sleep
- 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.
Dietary protein plus NMES during the dayProcedure or surgery
Neuromuscular electrical stimulation after a protein bolus, performed during the day
Dietary protein plus NMES prior to sleepProcedure or surgery
Neuromuscular electrical stimulation after a protein bolus, performed prior to sleep
| Study group | Role | What they receive |
|---|---|---|
| Treatment during the day | Active comparator | Neuromuscular electrical stimulation after a protein bolus, performed during the day Receives: Procedure: Dietary protein plus NMES during the day |
| Treatment prior to sleep | Active comparator | Protein ingestion directly after one-legged NMES, directly prior to sleep Receives: Procedure: Dietary protein plus NMES prior to sleep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incorporation of stable isotope amino acids into skeletal muscle tissue
Measured: 4-8 hours in the postprandial phase
Secondary outcomes (1)
Plasma amino acid enrichment
Measured: 4-8 hours in the postprandial phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study startJan 2015
- Primary completionMay 2015
- Study completionMay 2015
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 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
- None (open label)
- Enrolment
- 16 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 University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02253329
- Sponsor's protocol ID
- MEC 14-3-042
- Acronym
- ESPRO2
- Status last verified
- May 2015
- First submitted
- 29 Sep 2014
- Last updated
- 21 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Neuromuscular Electrical Stimulation on Post-prandial Protein Accretion During the Day and Prior to Sleep
- ClinicalTrials.gov ID
- NCT02253329
- Acronym / sponsor ID
- ESPRO2 / MEC 14-3-042
- Conditions
- Sarcopenia
- Keywords
- Neuromuscular electrical stimulation, Ageing, Protein ingestion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 1 Oct 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.
In the present study, the effect of a bolus of intrinsically labeled milk directly after one-legged NMES (Neuromuscular Electrical Stimulation) will be studied under two conditions: during the day and prior to sleep
Detailed description
In the present study, the effect of a bolus of intrinsically labeled milk directly after an hour of one-legged NMES (Neuromuscular Electrical Stimulation) will be studied under two conditions: during the day and immediately prior to sleep
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment during the day | Active comparator | Procedure: Dietary protein plus NMES during the dayNeuromuscular electrical stimulation after a protein bolus, performed during the day |
| Treatment prior to sleep | Active comparator | Procedure: Dietary protein plus NMES prior to sleepProtein ingestion directly after one-legged NMES, directly prior to sleep |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age 65-85 years
- Male
- 18.5 ≤ BMI ≤ 30.0
Key exclusion criteria (9 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 (non-steroidal anti-inflammatory drugs) 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 |
|---|---|---|
| Dietary protein plus NMES during the dayNeuromuscular electrical stimulation after a protein bolus, performed during the day | Procedure or surgery | Treatment during the day |
| Dietary protein plus NMES prior to sleepNeuromuscular electrical stimulation after a protein bolus, performed prior to sleep | Procedure or surgery | Treatment prior to sleep |
Primary outcome
Incorporation of stable isotope amino acids into skeletal muscle tissue
Time frame: 4-8 hours in the postprandial phase
1 secondary outcome
Plasma amino acid enrichment
Time frame: 4-8 hours in the postprandial phase
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 21 May 2015.
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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 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 Dietary protein plus NMES during the day and Dietary protein plus NMES prior to sleep 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 9 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 21 May 2015. 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?
Incorporation of stable isotope amino acids into skeletal muscle tissue (time frame: 4-8 hours in the postprandial phase). 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 21 May 2015.