Immobilization and Protein Supplementation (IM-PRO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lex Verdijk, Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01588808
First received: April 26, 2012
Last updated: July 9, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Disuse Atrophy
Aging
Behavioral: Immobilization

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: The Impact of Dietary Protein Supplementation and Age on Muscle Mass Loss During Short Term One-legged Knee Immobilization

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Change in muscle mass [ Time Frame: three days before immobilization, and directly after immobilization (day of cast removal; day 6) ] [ Designated as safety issue: No ]
  • Change in muscle fiber size [ Time Frame: three days before immobilization, and directly after immobilization (day of cast removal; day 6) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: May 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Immobilization with protein (elderly)
Immobilization with twice-daily protein supplementation - in the elderly
Behavioral: Immobilization
Immobilization with protein (elderlY), immobilization without protein (elderly and young)
Placebo Comparator: Immobilization without protein (elderly)
Immobilization without twice-daily protein supplementation - in the elderly
Behavioral: Immobilization
Immobilization with protein (elderlY), immobilization without protein (elderly and young)
Active Comparator: Immobilization without protein (young)
Immobilization without twice-daily protein supplementation - in the young
Behavioral: Immobilization
Immobilization with protein (elderlY), immobilization without protein (elderly and young)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01588808

Locations
Netherlands
Maastricht University Medical Centre
Maastricht, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Luc JC van Loon, PhD Maastricht UMC
  More Information

No publications provided

Responsible Party: Lex Verdijk, Assistant Professor, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01588808     History of Changes
Other Study ID Numbers: MEC 12-3-012
Study First Received: April 26, 2012
Last Updated: July 9, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Immobilization
Protein supplementation

Additional relevant MeSH terms:
Muscular Disorders, Atrophic
Atrophy
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on April 15, 2014