Immobilization and Protein Supplementation (IM-PRO)

Aging Clinical Trial

— IM-PRO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01588808
• Other study ID #: MEC 12-3-012
• Status: Completed
• Phase: N/A
• First received: April 26, 2012
• Last updated: July 9, 2013
• Start date: May 2012
• Est. completion date: February 2013

Study information

• Verified date: July 2013
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Aging
• Disuse Atrophy

Intervention

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

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Centre	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in muscle mass		three days before immobilization, and directly after immobilization (day of cast removal; day 6)	No
Primary	Change in muscle fiber size		three days before immobilization, and directly after immobilization (day of cast removal; day 6)	No
Secondary	Change in muscle strength measured by quadriceps 1-Repetition Maximum by Leg Extension		Three days before immobilization, and directly after immobilization (day of cast removal; day 6)	No