- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01317511
Protein Supply in Elderly
March 16, 2011 updated by: Maastricht University Medical Center
Overnight Protein Supply as a Dietary Strategy to Improve Muscle Mass in Elderly.
Stimulating overnight muscle protein synthesis, might augment muscle hypertrophy, increase mitochondrial mass, and/or improve muscle tissue repair.
The goal of this proposal will be to provide further insight into the responsiveness of the muscle protein synthetic machinery to food intake in relation to age.
Study Overview
Study Type
Interventional
Enrollment (Actual)
16
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
-
-
Limburg
-
Maastricht, Limburg, Netherlands, 6229ER
- 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
65 years to 80 years (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Males
- Age between 65 and 80 years
- BMI < 30 kg/m2
Exclusion Criteria:
- Type 2 diabetic patients
- Use of medication
- All co morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. artrosis, arthritis, spasticity/rigidity, all neurological disorders and paralysis).
- Use of anticoagulants, blood diseases, allergy for lidocain.
- Contra indications for the use of a nasogastric tube: high risk of aspiration, gastric stasis, gastro-oesophageal reflux, upper gastrointestinal stricture, nasal injuries and base of skull fractures.
- Patients suffering from PKU (Phenylketonuria).
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Protein
Protein drink
|
Protein drink
Other Names:
|
Placebo Comparator: Placebo
water
|
Protein drink
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Protein synthesis
Time Frame: overnight (12 h)
|
Overnight protein synthesis
|
overnight (12 h)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Luc van Loon, Prof., Maastricht UMC
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.
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
June 1, 2010
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
February 1, 2011
Study Registration Dates
First Submitted
March 16, 2011
First Submitted That Met QC Criteria
March 16, 2011
First Posted (Estimate)
March 17, 2011
Study Record Updates
Last Update Posted (Estimate)
March 17, 2011
Last Update Submitted That Met QC Criteria
March 16, 2011
Last Verified
March 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MEC 09-3-078.3
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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