NMES During the Day and Prior to Sleep (ESPRO2)

May 20, 2015 updated by: Maastricht University Medical Center

The Effect of Neuromuscular Electrical Stimulation on Post-prandial Protein Accretion During the Day and Prior to Sleep

In the present study, the effect of a bolus of intrinsically labeled milk directly after one-legged NMES (Neuromuscular Electrical Stimulation) will be studied under two conditions: during the day and prior to sleep

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In the present study, the effect of a bolus of intrinsically labeled milk directly after an hour of one-legged NMES (Neuromuscular Electrical Stimulation) will be studied under two conditions: during the day and immediately prior to sleep

Study Type

Interventional

Enrollment (Actual)

16

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:

  • Age 65-85 years
  • Male
  • 18.5 ≤ BMI ≤ 30.0

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 (non-steroidal anti-inflammatory drugs) 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
  • Use of any tools to assist during walking (cane/ crutches/ walker)
  • (Partial) foot/ leg amputation

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment during the day
Neuromuscular electrical stimulation after a protein bolus, performed during the day
Procedure: Dietary protein plus NMES during the day
Neuromuscular electrical stimulation after a protein bolus, performed during the day
Active Comparator: Treatment prior to sleep
Protein ingestion directly after one-legged NMES, directly prior to sleep
Procedure: Dietary protein plus NMES prior to sleep
Neuromuscular electrical stimulation after a protein bolus, performed prior to sleep

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incorporation of stable isotope amino acids into skeletal muscle tissue
Time Frame: 4-8 hours in the postprandial phase
4-8 hours in the postprandial phase

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma amino acid enrichment
Time Frame: 4-8 hours in the postprandial phase
4-8 hours in the postprandial phase

Collaborators and Investigators

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

Sponsor

Maastricht University Medical Center

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

January 1, 2015

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

September 29, 2014

First Submitted That Met QC Criteria

September 29, 2014

First Posted (Estimate)

October 1, 2014

Study Record Updates

Last Update Posted (Estimate)

May 21, 2015

Last Update Submitted That Met QC Criteria

May 20, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC 14-3-042

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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