Immobilization and Protein Supplementation (IM-PRO)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-02-28

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.

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Detailed Description

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Conditions

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Disuse Atrophy Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Immobilization with protein (elderly)

Immobilization with twice-daily protein supplementation - in the elderly

Group Type ACTIVE_COMPARATOR

Immobilization

Intervention Type BEHAVIORAL

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

Immobilization without protein (elderly)

Immobilization without twice-daily protein supplementation - in the elderly

Group Type PLACEBO_COMPARATOR

Immobilization

Intervention Type BEHAVIORAL

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

Immobilization without protein (young)

Immobilization without twice-daily protein supplementation - in the young

Group Type ACTIVE_COMPARATOR

Immobilization

Intervention Type BEHAVIORAL

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

Interventions

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Immobilization

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

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes