Immobilization and Protein Supplementation (IM-PRO) (IM-PRO)

July 9, 2013 updated by: Lex Verdijk, Maastricht University Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands
        • Maastricht University Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in muscle mass
Time Frame: three days before immobilization, and directly after immobilization (day of cast removal; day 6)
three days before immobilization, and directly after immobilization (day of cast removal; day 6)
Change in muscle fiber size
Time Frame: three days before immobilization, and directly after immobilization (day of cast removal; day 6)
three days before immobilization, and directly after immobilization (day of cast removal; day 6)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
Three days before immobilization, and directly after immobilization (day of cast removal; day 6)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

April 26, 2012

First Submitted That Met QC Criteria

April 27, 2012

First Posted (Estimate)

May 1, 2012

Study Record Updates

Last Update Posted (Estimate)

July 10, 2013

Last Update Submitted That Met QC Criteria

July 9, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC 12-3-012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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