Immobilization and Protein Supplementation (IM-PRO)
This study is currently recruiting participants.
Verified May 2012 by Maastricht University Medical Center
Sponsor:
Maastricht University Medical Center
Information provided by (Responsible Party):
Lex Verdijk, Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01588808
First received: April 26, 2012
Last updated: May 10, 2012
Last verified: May 2012
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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 ]
| Estimated Enrollment: | 45 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | March 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
Contacts
| Contact: Benjamin T. Wall, PhD | +31-433882215 | benjamin.wall@maastrichtuniversity.nl |
| Contact: Marlou L. Dirks, MSc | +31-422882215 | marlou.dirks@maastrichtuniversity.nl |
Locations
| Netherlands | |
| Maastricht University Medical Centre | Recruiting |
| Maastricht, Netherlands | |
| Contact: Luc JC van Loon, PhD +31-433881397 l.vanloon@maastrichtuniversity.nl | |
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: | May 10, 2012 |
| 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 May 23, 2013