- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01145131
Dietary Interventions for Muscle Mass
September 13, 2011 updated by: Maastricht University Medical Center
Dietary intervention to prevent sarcopenia in elderly people.
The objective of this study is to test whether meat structure plays an important role in protein digestion, to maximise the amino acid availability and to stimulate the muscle protein growth in elderly people.
Study Overview
Study Type
Interventional
Enrollment (Actual)
12
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
- Universiteit Maastricht, Bewegingswetenschappen
-
-
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 85 years (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Non-obese male subjects (BMI<30) between the age of 65-85 years.
Exclusion Criteria:
- Type II diabetes or other known diseases, use of medication, female, other ages or BMI than indicated above, participation in any regular exercise program.
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: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Beef steak
|
135 gram piece of intact or minced beef meat, beef steak or minced beef resp.
Other Names:
|
Experimental: Minced beef
|
135 gram piece of intact or minced beef meat, beef steak or minced beef resp.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle protein synthesis
Time Frame: 6 h postprandial period
|
Muscle protein synthesis will be expressed as fractional synthetic rate (FSR) by dividing the increment in enrichment in the product, i.e. protein-bound D5phe tracer, by the enrichment of the precursor (=plasma availability).
|
6 h postprandial period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dietary amino acid plasma availability
Time Frame: 6h postprandial period
|
The exogenous rate of phenylalanine appearance will be used to assess the bio-availability of dietary-protein derived amino acids in the circulation during the 6h postprandial period following meat intake
|
6h postprandial period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: B Pennings, Ir, 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
- Mioche L, Bourdiol P, Monier S, Martin JF, Cormier D. Changes in jaw muscles activity with age: effects on food bolus properties. Physiol Behav. 2004 Sep 30;82(4):621-7. doi: 10.1016/j.physbeh.2004.05.012.
- Mioche L, Bourdiol P, Monier S. Chewing behaviour and bolus formation during mastication of meat with different textures. Arch Oral Biol. 2003 Mar;48(3):193-200. doi: 10.1016/s0003-9969(03)00002-5.
- Pennings B, Groen BB, van Dijk JW, de Lange A, Kiskini A, Kuklinski M, Senden JM, van Loon LJ. Minced beef is more rapidly digested and absorbed than beef steak, resulting in greater postprandial protein retention in older men. Am J Clin Nutr. 2013 Jul;98(1):121-8. doi: 10.3945/ajcn.112.051201. Epub 2013 May 1.
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, 2011
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
June 15, 2010
First Submitted That Met QC Criteria
June 15, 2010
First Posted (Estimate)
June 16, 2010
Study Record Updates
Last Update Posted (Estimate)
September 14, 2011
Last Update Submitted That Met QC Criteria
September 13, 2011
Last Verified
September 1, 2011
More Information
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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