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Completed

NCT Number: NCT01588808

Immobilization and Protein Supplementation (IM-PRO)

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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Key information

Conditions

Disuse Atrophy Aging Muscular Diseases Muscular Disorders, Atrophic Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Centre

Maastricht, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

immobilization

Behavioral

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

Primary outcomes

  1. Change in muscle mass

    Time frame: three days before immobilization, and directly after immobilization (day of cast removal; day 6)

  2. Change in muscle fiber size

    Time frame: three days before immobilization, and directly after immobilization (day of cast removal; day 6)

Secondary outcomes

  1. Change in muscle strength measured by quadriceps 1-Repetition Maximum by Leg Extension

    Time frame: Three days before immobilization, and directly after immobilization (day of cast removal; day 6)

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

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

Acronym: IM-PRO

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 1, 2012
Registry last updated
Jul 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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