Back to resultsNMES During the Day and Prior to Sleep (ESPRO2)
Primary Purpose
Sarcopenia
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Dietary protein plus NMES during the day
Dietary protein plus NMES prior to sleep
Sponsored by
About this trial
This is an interventional prevention trial for Sarcopenia focused on measuring Neuromuscular electrical stimulation, Ageing, Protein ingestion
Eligibility Criteria
Inclusion Criteria:
- Age 65-85 years
- Male
- 18.5 ≤ BMI ≤ 30.0
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Maastricht University Medical Centre +
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Treatment during the day
Treatment prior to sleep
Arm Description
Neuromuscular electrical stimulation after a protein bolus, performed during the day
Protein ingestion directly after one-legged NMES, directly prior to sleep
Outcomes
Primary Outcome Measures
Incorporation of stable isotope amino acids into skeletal muscle tissue
Secondary Outcome Measures
Plasma amino acid enrichment
Full Information
NCT ID
NCT02253329
First Posted
September 29, 2014
Last Updated
May 20, 2015
Sponsor
Maastricht University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02253329
Brief Title
NMES During the Day and Prior to Sleep
Acronym
ESPRO2
Official Title
The Effect of Neuromuscular Electrical Stimulation on Post-prandial Protein Accretion During the Day and Prior to Sleep
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
Neuromuscular electrical stimulation, Ageing, Protein ingestion
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment during the day
Arm Type
Active Comparator
Arm Description
Neuromuscular electrical stimulation after a protein bolus, performed during the day
Arm Title
Treatment prior to sleep
Arm Type
Active Comparator
Arm Description
Protein ingestion directly after one-legged NMES, directly prior to sleep
Intervention Type
Procedure
Intervention Name(s)
Dietary protein plus NMES during the day
Intervention Description
Neuromuscular electrical stimulation after a protein bolus, performed during the day
Intervention Type
Procedure
Intervention Name(s)
Dietary protein plus NMES prior to sleep
Intervention Description
Neuromuscular electrical stimulation after a protein bolus, performed prior to sleep
Primary Outcome Measure Information:
Title
Incorporation of stable isotope amino acids into skeletal muscle tissue
Time Frame
4-8 hours in the postprandial phase
Secondary Outcome Measure Information:
Title
Plasma amino acid enrichment
Time Frame
4-8 hours in the postprandial phase
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 65-85 years
Male
18.5 ≤ BMI ≤ 30.0
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luc JC van Loon, PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Centre +
City
Maastricht
Country
Netherlands
12. IPD Sharing Statement
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NMES During the Day and Prior to Sleep
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