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

May 30, 2013 updated by: Maastricht University Medical Center

The Effect of Neuromuscular Electrical Stimulation on Post-prandial Muscle Protein Accretion in Healthy Elderly Men

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands
        • Maastricht University Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 85 years (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tracer enrichment in the muscle biopsy
Time Frame: 4 hours after protein ingestion
4 hours after protein ingestion

Secondary Outcome Measures

Outcome Measure
Time Frame
Fractional synthetic rate (FSR)
Time Frame: 0-4 hours after protein ingestion
0-4 hours after protein ingestion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

May 30, 2012

First Submitted That Met QC Criteria

June 7, 2012

First Posted (Estimate)

June 8, 2012

Study Record Updates

Last Update Posted (Estimate)

May 31, 2013

Last Update Submitted That Met QC Criteria

May 30, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC 12-3-020

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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