Skip to content

Immobilization and Protein Supplementation (IM-PRO)

The Impact of Dietary Protein Supplementation and Age on Muscle Mass Loss During Short Term One-legged Knee Immobilization

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01588808
Acronym
IM-PRO
Enrollment
35
Registered
2012-05-01
Start date
2012-05-31
Completion date
2013-02-28
Last updated
2013-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Disuse Atrophy

Keywords

Immobilization, Protein supplementation

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.

Interventions

BEHAVIORALImmobilization

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

Sponsors

Maastricht University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

* Male * Aged from 18-35 years and from 65-75 years * 18.5 \< BMI \< 30 kg/m2

Exclusion criteria

* 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 * Known galactosemia

Design outcomes

Primary

MeasureTime frame
Change in muscle massthree days before immobilization, and directly after immobilization (day of cast removal; day 6)
Change in muscle fiber sizethree days before immobilization, and directly after immobilization (day of cast removal; day 6)

Secondary

MeasureTime frame
Change in muscle strength measured by quadriceps 1-Repetition Maximum by Leg ExtensionThree days before immobilization, and directly after immobilization (day of cast removal; day 6)

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026