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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01145131
Other study ID # MEC 10-3-065
Secondary ID
Status Completed
Phase N/A
First received June 15, 2010
Last updated September 13, 2011
Start date May 2011
Est. completion date June 2011

Study information

Verified date September 2011
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

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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 65 Years to 85 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
Intact or minced beef meat
135 gram piece of intact or minced beef meat, beef steak or minced beef resp.

Locations

Country Name City State
Netherlands Universiteit Maastricht, Bewegingswetenschappen Maastricht Limburg

Sponsors (1)

Lead Sponsor Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Muscle protein synthesis 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 No
Secondary Dietary amino acid plasma availability 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 No
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