Neuromuscular Electrical Stimulation (NMES) and Muscle Protein Accretion (ES-PRO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01615276
First received: May 30, 2012
Last updated: May 30, 2013
Last verified: May 2013
  Purpose

In the present study, the effect of a bolus of intrinsically labeled milk directly after one-legged NMES will be studied.


Condition Intervention
Sarcopenia
Device: Enraf Nonius Tensmed S84 for Neuromuscular electrical stimulation (NMES)
Device: No Enraf Nonius Tensmed S84 for Neuromuscular electrical stimulation (NMES) NMES

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: The Effect of Neuromuscular Electrical Stimulation on Post-prandial Muscle Protein Accretion in Healthy Elderly Men

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Tracer enrichment in the muscle biopsy [ Time Frame: 4 hours after protein ingestion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fractional synthetic rate (FSR) [ Time Frame: 0-4 hours after protein ingestion ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: October 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Protein ingestion
Protein ingestion directly after the contralateral leg received NMES
Device: No Enraf Nonius Tensmed S84 for Neuromuscular electrical stimulation (NMES) NMES
No neuromuscular electrical stimulation (NMES) will be applied in the control leg
Experimental: Protein ingestion after NMES
Ingestion of intrinsically labeled protein, directly after one hour of Neuromuscular electrical stimulation (NMES)
Device: Enraf Nonius Tensmed S84 for Neuromuscular electrical stimulation (NMES)
One our of one-legged neuromuscular electrical stimulation (NMES)

  Eligibility

Ages Eligible for Study:   65 Years to 85 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01615276

Locations
Netherlands
Maastricht University Medical Centre
Maastricht, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Luc JC van Loon, PhD Maastricht UMC
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01615276     History of Changes
Other Study ID Numbers: MEC 12-3-020
Study First Received: May 30, 2012
Last Updated: May 30, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Neuromuscular Electrical Stimulation
Ageing
Protein ingestion

Additional relevant MeSH terms:
Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014