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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01239277
Other study ID # MEC 10-3-080
Secondary ID
Status Completed
Phase N/A
First received November 10, 2010
Last updated September 13, 2011
Start date January 2011
Est. completion date July 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 combined nutrient intake plays an important role in stimulation of the muscle protein growth in elderly people; and whether it represent effective strategies to overcome the impaired muscle protein synthesis in elderly when compared with young subjects.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date July 2011
Est. primary completion date July 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 70 Years to 85 Years
Eligibility Inclusion Criteria:

- males

- 70-85 years or 18-30 years

- BMI < 30

Exclusion Criteria:

- Type II diabetes

- All co morbidities interacting with mobility and muscle metabolism of the lower limbs

- Use of anticoagulants

- Patients suffering from Phenylketonuria

- Participation in any regular exercise programme

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
protein
20g protein
protein and carbohydrate
20g protein and 20g carbohydrate
protein and leucine
20g protein, 2.5g leucine

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, 

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 C13phe, by the enrichment of the precursor (=plasma availability). 6 h postprandial period No
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