Immobilization and Protein Supplementation (IM-PRO)

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Disuse Atrophy; Aging

Treatments: Behavioral: Immobilization

Study type: Interventional

Funder types: Other

Identifiers

NCT01588808

MEC 12-3-012

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 3 patient groups, including a placebo group

Immobilization with protein (elderly)

Active Comparator group

Description:

Immobilization with twice-daily protein supplementation - in the elderly

Treatment:

Behavioral: Immobilization

Immobilization without protein (elderly)

Placebo Comparator group

Description:

Immobilization without twice-daily protein supplementation - in the elderly

Treatment:

Behavioral: Immobilization

Immobilization without protein (young)

Active Comparator group

Description:

Immobilization without twice-daily protein supplementation - in the young

Treatment:

Behavioral: Immobilization