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

Primary Purpose

Disuse Atrophy, Aging

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Immobilization
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Disuse Atrophy focused on measuring Immobilization, Protein supplementation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Maastricht University Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

Immobilization with protein (elderly)

Immobilization without protein (elderly)

Immobilization without protein (young)

Arm Description

Immobilization with twice-daily protein supplementation - in the elderly

Immobilization without twice-daily protein supplementation - in the elderly

Immobilization without twice-daily protein supplementation - in the young

Outcomes

Primary Outcome Measures

Change in muscle mass
Change in muscle fiber size

Secondary Outcome Measures

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

Full Information

First Posted
April 26, 2012
Last Updated
July 9, 2013
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01588808
Brief Title
Immobilization and Protein Supplementation (IM-PRO)
Acronym
IM-PRO
Official Title
The Impact of Dietary Protein Supplementation and Age on Muscle Mass Loss During Short Term One-legged Knee Immobilization
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maastricht University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disuse Atrophy, Aging
Keywords
Immobilization, Protein supplementation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immobilization with protein (elderly)
Arm Type
Active Comparator
Arm Description
Immobilization with twice-daily protein supplementation - in the elderly
Arm Title
Immobilization without protein (elderly)
Arm Type
Placebo Comparator
Arm Description
Immobilization without twice-daily protein supplementation - in the elderly
Arm Title
Immobilization without protein (young)
Arm Type
Active Comparator
Arm Description
Immobilization without twice-daily protein supplementation - in the young
Intervention Type
Behavioral
Intervention Name(s)
Immobilization
Intervention Description
Immobilization with protein (elderlY), immobilization without protein (elderly and young)
Primary Outcome Measure Information:
Title
Change in muscle mass
Time Frame
three days before immobilization, and directly after immobilization (day of cast removal; day 6)
Title
Change in muscle fiber size
Time Frame
three days before immobilization, and directly after immobilization (day of cast removal; day 6)
Secondary Outcome Measure Information:
Title
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)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luc JC van Loon, PhD
Organizational Affiliation
Maastricht UMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Centre
City
Maastricht
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
24919692
Citation
Dirks ML, Wall BT, Nilwik R, Weerts DH, Verdijk LB, van Loon LJ. Skeletal muscle disuse atrophy is not attenuated by dietary protein supplementation in healthy older men. J Nutr. 2014 Aug;144(8):1196-203. doi: 10.3945/jn.114.194217. Epub 2014 Jun 11.
Results Reference
derived

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Immobilization and Protein Supplementation (IM-PRO)

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