NCT01588808

Brief Summary

In the present study, the effects of 5 days of lower limb immobilization with or without twice-daily protein supplementation on muscle mass and muscle fiber characteristics will be determined. A young group will be included to compare the changes in muscle mass and muscle fiber characteristics between young and old men.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 1, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

July 10, 2013

Status Verified

July 1, 2013

Enrollment Period

9 months

First QC Date

April 26, 2012

Last Update Submit

July 9, 2013

Conditions

Disuse AtrophyAging

Keywords

ImmobilizationProtein supplementation

Outcome Measures

Primary Outcomes (2)

  • Change in muscle mass

    three days before immobilization, and directly after immobilization (day of cast removal; day 6)

  • Change in muscle fiber size

    three days before immobilization, and directly after immobilization (day of cast removal; day 6)

Secondary Outcomes (1)

  • Change in muscle strength measured by quadriceps 1-Repetition Maximum by Leg Extension

    Three days before immobilization, and directly after immobilization (day of cast removal; day 6)

Study Arms (3)

Immobilization with protein (elderly)

ACTIVE COMPARATOR

Immobilization with twice-daily protein supplementation - in the elderly

Behavioral: Immobilization

Immobilization without protein (elderly)

PLACEBO COMPARATOR

Immobilization without twice-daily protein supplementation - in the elderly

Behavioral: Immobilization

Immobilization without protein (young)

ACTIVE COMPARATOR

Immobilization without twice-daily protein supplementation - in the young

Behavioral: Immobilization

Interventions

ImmobilizationBEHAVIORAL

Immobilization with protein (elderlY), immobilization without protein (elderly and young)

Immobilization with protein (elderly)Immobilization without protein (elderly)Immobilization without protein (young)

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male
  • Aged from 18-35 years and from 65-75 years
  • \< BMI \< 30 kg/m2

You may not qualify if:

  • Smoking
  • Performing regular resistance training in the previous 6 months
  • Hypertension (according to WHO criteria) \[52\] and/or cardiovascular disease
  • Any back/leg/knee/shoulder complaints which may interfere with the use of crutches
  • Systemic use of antibiotics within 3 weeks prior to the study visit
  • Current systemic use of corticosteroids, growth hormone, testosterone, immunosuppressants or insulin
  • Type 2 diabetes mellitus
  • Any history of thrombosis
  • Any family history (1st grade) of thrombosis
  • All co-morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. arthritis, spasticity/rigidity, all neurological disorders and paralysis).
  • Myocardial infarction within the last 3 years
  • Use of anti-coagulants
  • Any (history of) gastrointestinal disease that interferes with GI function
  • Indications related to interaction with the study product:
  • Known allergy to milk or milk products
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Centre

Maastricht, Netherlands

Location

Related Publications (1)

  • Dirks ML, Wall BT, Nilwik R, Weerts DH, Verdijk LB, van Loon LJ. Skeletal muscle disuse atrophy is not attenuated by dietary protein supplementation in healthy older men. J Nutr. 2014 Aug;144(8):1196-203. doi: 10.3945/jn.114.194217. Epub 2014 Jun 11.

    PMID: 24919692DERIVED

MeSH Terms

Conditions

Muscular Disorders, Atrophic

Interventions

Immobilization

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

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
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 26, 2012

First Posted

May 1, 2012

Study Start

May 1, 2012

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

July 10, 2013

Record last verified: 2013-07

Locations

NL(1)