Immobilization and Protein Supplementation (IM-PRO)

Not Applicable

Completed

• Conditions: Disuse Atrophy; Aging
• Interventions: Behavioral: Immobilization

• Registration Number: NCT01588808
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-26
• Study First Submitted QC: 2012-04-27
• Study Start: 2012-05
• Study First Posted: 2012-05-01
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-09
• Last Update Posted: 2013-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immobilization with protein (elderly)	Immobilization	Immobilization with twice-daily protein supplementation - in the elderly
Immobilization without protein (elderly)	Immobilization	Immobilization without twice-daily protein supplementation - in the elderly
Immobilization without protein (young)	Immobilization	Immobilization without twice-daily protein supplementation - in the young

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Maastricht University Medical Centre; 🇳🇱 Maastricht, Netherlands