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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01615276
First Posted: June 8, 2012
Last Update Posted: May 31, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Maastricht University Medical Center
  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: None (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 ]

Secondary Outcome Measures:
  • Fractional synthetic rate (FSR) [ Time Frame: 0-4 hours after protein ingestion ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 85 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01615276     History of Changes
Other Study ID Numbers: MEC 12-3-020
First Submitted: May 30, 2012
First Posted: June 8, 2012
Last Update Posted: May 31, 2013
Last Verified: May 2013

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