NMES During the Day and Prior to Sleep

Sarcopenia Clinical Trial

— ESPRO2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02253329
• Other study ID #: MEC 14-3-042
• Status: Completed
• Phase: N/A
• First received: September 29, 2014
• Last updated: May 20, 2015
• Start date: January 2015
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• 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 (Neuromuscular Electrical Stimulation) will be studied under two conditions: during the day and prior to sleep

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 65 Years to 85 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Procedure:
• Dietary protein plus NMES during the day
Neuromuscular electrical stimulation after a protein bolus, performed during the day
• Dietary protein plus NMES prior to sleep
Neuromuscular electrical stimulation after a protein bolus, performed prior to sleep

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	Incorporation of stable isotope amino acids into skeletal muscle tissue		4-8 hours in the postprandial phase	No
Secondary	Plasma amino acid enrichment		4-8 hours in the postprandial phase	No