Immobilization and Protein Supplementation (IM-PRO)

Study Overview
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Brief Summary
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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.

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

Conditions
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Disuse Atrophy, Aging

Intervention / Treatment
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* Behavioral: Immobilization


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Immobilization with protein (elderly)<br>Immobilization with twice-daily protein supplementation - in the elderly | Behavioral: Immobilization<br>* Immobilization with protein (elderlY), immobilization without protein (elderly and young)<br>|
| Placebo Comparator: Immobilization without protein (elderly)<br>Immobilization without twice-daily protein supplementation - in the elderly | Behavioral: Immobilization<br>* Immobilization with protein (elderlY), immobilization without protein (elderly and young)<br>|
| Active Comparator: Immobilization without protein (young)<br>Immobilization without twice-daily protein supplementation - in the young | Behavioral: Immobilization<br>* Immobilization with protein (elderlY), immobilization without protein (elderly and young)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immobilization, Protein supplementation