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

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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 July 21, 2017