NCT02253329

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 1, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

May 21, 2015

Status Verified

May 1, 2015

Enrollment Period

4 months

First QC Date

September 29, 2014

Last Update Submit

May 20, 2015

Conditions

Sarcopenia

Keywords

Neuromuscular electrical stimulationAgeingProtein ingestion

Outcome Measures

Primary Outcomes (1)

  • Incorporation of stable isotope amino acids into skeletal muscle tissue

    4-8 hours in the postprandial phase

Secondary Outcomes (1)

  • Plasma amino acid enrichment

    4-8 hours in the postprandial phase

Study Arms (2)

Treatment during the day

ACTIVE COMPARATOR

Neuromuscular electrical stimulation after a protein bolus, performed during the day

Procedure: Dietary protein plus NMES during the day

Treatment prior to sleep

ACTIVE COMPARATOR

Protein ingestion directly after one-legged NMES, directly prior to sleep

Procedure: Dietary protein plus NMES prior to sleep

Interventions

Dietary protein plus NMES during the dayPROCEDURE

Neuromuscular electrical stimulation after a protein bolus, performed during the day

Treatment during the day
Dietary protein plus NMES prior to sleepPROCEDURE

Neuromuscular electrical stimulation after a protein bolus, performed prior to sleep

Treatment prior to sleep

Eligibility Criteria

Age65 Years - 85 Years
Sexmale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Centre +

Maastricht, Netherlands

Location

MeSH Terms

Conditions

Sarcopenia

Interventions

Dietary Proteins

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

ProteinsAmino Acids, Peptides, and ProteinsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Luc JC van Loon, PhD

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2014

First Posted

October 1, 2014

Study Start

January 1, 2015

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

May 21, 2015

Record last verified: 2015-05

Locations

NL(1)