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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Maastricht University Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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

ClinicalTrials.gov processed this record on October 20, 2014