Back to resultsNeuromuscular Electrical Stimulation (NMES) and Muscle Protein Accretion (ES-PRO) (ES-PRO)
Primary Purpose
Sarcopenia
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Enraf Nonius Tensmed S84 for Neuromuscular electrical stimulation (NMES)
No Enraf Nonius Tensmed S84 for Neuromuscular electrical stimulation (NMES) NMES
Sponsored by
About this trial
This is an interventional basic science trial for Sarcopenia focused on measuring Neuromuscular Electrical Stimulation, Ageing, Protein ingestion
Eligibility Criteria
Inclusion Criteria:
- Male
- Age 65 - 85 years
- 18.5 < BMI < 30 kg∙m2
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 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
Sites / Locations
- Maastricht University Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Protein ingestion
Protein ingestion after NMES
Arm Description
Protein ingestion directly after the contralateral leg received NMES
Ingestion of intrinsically labeled protein, directly after one hour of Neuromuscular electrical stimulation (NMES)
Outcomes
Primary Outcome Measures
Tracer enrichment in the muscle biopsy
Secondary Outcome Measures
Fractional synthetic rate (FSR)
Full Information
NCT ID
NCT01615276
First Posted
May 30, 2012
Last Updated
May 30, 2013
Sponsor
Maastricht University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01615276
Brief Title
Neuromuscular Electrical Stimulation (NMES) and Muscle Protein Accretion (ES-PRO)
Acronym
ES-PRO
Official Title
The Effect of Neuromuscular Electrical Stimulation on Post-prandial Muscle Protein Accretion in Healthy Elderly Men
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In the present study, the effect of a bolus of intrinsically labeled milk directly after one-legged NMES will be studied.
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
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Protein ingestion
Arm Type
Placebo Comparator
Arm Description
Protein ingestion directly after the contralateral leg received NMES
Arm Title
Protein ingestion after NMES
Arm Type
Experimental
Arm Description
Ingestion of intrinsically labeled protein, directly after one hour of Neuromuscular electrical stimulation (NMES)
Intervention Type
Device
Intervention Name(s)
Enraf Nonius Tensmed S84 for Neuromuscular electrical stimulation (NMES)
Intervention Description
One our of one-legged neuromuscular electrical stimulation (NMES)
Intervention Type
Device
Intervention Name(s)
No Enraf Nonius Tensmed S84 for Neuromuscular electrical stimulation (NMES) NMES
Intervention Description
No neuromuscular electrical stimulation (NMES) will be applied in the control leg
Primary Outcome Measure Information:
Title
Tracer enrichment in the muscle biopsy
Time Frame
4 hours after protein ingestion
Secondary Outcome Measure Information:
Title
Fractional synthetic rate (FSR)
Time Frame
0-4 hours after protein ingestion
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:
Male
Age 65 - 85 years
18.5 < BMI < 30 kg∙m2
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luc JC van Loon, PhD
Organizational Affiliation
Maastricht UMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Centre
City
Maastricht
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
32069356
Citation
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.
Results Reference
derived
Learn more about this trial
Neuromuscular Electrical Stimulation (NMES) and Muscle Protein Accretion (ES-PRO)
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