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

Sarcopenia Clinical Trial

— ES-PRO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01615276
• Other study ID #: MEC 12-3-020
• Status: Completed
• Phase: N/A
• First received: May 30, 2012
• Last updated: May 30, 2013
• Start date: October 2012
• Est. completion date: January 2013

Study information

• Verified date: May 2013
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 65 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Device:
• Enraf Nonius Tensmed S84 for Neuromuscular electrical stimulation (NMES)
One our of one-legged neuromuscular electrical stimulation (NMES)
• No Enraf Nonius Tensmed S84 for Neuromuscular electrical stimulation (NMES) NMES
No neuromuscular electrical stimulation (NMES) will be applied in the control leg

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Centre	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tracer enrichment in the muscle biopsy		4 hours after protein ingestion	No
Secondary	Fractional synthetic rate (FSR)		0-4 hours after protein ingestion	No