NCT01615276

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2012

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

May 30, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 8, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

May 31, 2013

Status Verified

May 1, 2013

Enrollment Period

3 months

First QC Date

May 30, 2012

Last Update Submit

May 30, 2013

Conditions

Sarcopenia

Keywords

Neuromuscular Electrical StimulationAgeingProtein ingestion

Outcome Measures

Primary Outcomes (1)

  • Tracer enrichment in the muscle biopsy

    4 hours after protein ingestion

Secondary Outcomes (1)

  • Fractional synthetic rate (FSR)

    0-4 hours after protein ingestion

Study Arms (2)

Protein ingestion

PLACEBO COMPARATOR

Protein ingestion directly after the contralateral leg received NMES

Device: No Enraf Nonius Tensmed S84 for Neuromuscular electrical stimulation (NMES) NMES

Protein ingestion after NMES

EXPERIMENTAL

Ingestion of intrinsically labeled protein, directly after one hour of Neuromuscular electrical stimulation (NMES)

Device: Enraf Nonius Tensmed S84 for Neuromuscular electrical stimulation (NMES)

Interventions

Enraf Nonius Tensmed S84 for Neuromuscular electrical stimulation (NMES)DEVICE

One our of one-legged neuromuscular electrical stimulation (NMES)

Protein ingestion after NMES
No Enraf Nonius Tensmed S84 for Neuromuscular electrical stimulation (NMES) NMESDEVICE

No neuromuscular electrical stimulation (NMES) will be applied in the control leg

Protein ingestion

Eligibility Criteria

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

You may qualify if:

  • Male
  • Age 65 - 85 years
  • \< BMI \< 30 kg∙m2

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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Centre

Maastricht, Netherlands

Location

Related Publications (1)

  • Gorissen SHM, Trommelen J, Kouw IWK, Holwerda AM, Pennings B, Groen BBL, Wall BT, Churchward-Venne TA, Horstman AMH, Koopman R, Burd NA, Fuchs CJ, Dirks ML, Res PT, Senden JMG, Steijns JMJM, de Groot LCPGM, Verdijk LB, van Loon LJC. Protein Type, Protein Dose, and Age Modulate Dietary Protein Digestion and Phenylalanine Absorption Kinetics and Plasma Phenylalanine Availability in Humans. J Nutr. 2020 Aug 1;150(8):2041-2050. doi: 10.1093/jn/nxaa024.

    PMID: 32069356DERIVED

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

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

Study Officials

  • Luc JC van Loon, PhD

    Maastricht UMC

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 30, 2012

First Posted

June 8, 2012

Study Start

October 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

May 31, 2013

Record last verified: 2013-05

Locations

NL(1)