Text Size

Combined Nutrient Intake and Muscle Protein Synthesis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01239277
First received: November 10, 2010
Last updated: September 13, 2011
Last verified: September 2011
History of Changes
  Purpose

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.


Condition Intervention
Aging
 Other: protein
Other: protein and carbohydrate
Other: protein and leucine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Combined Nutrient Intake and Muscle Protein Synthesis

Resource links provided by NLM:

Drug Information available for: Leucine
U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Muscle protein synthesis [ Time Frame: 6 h postprandial period ] [ Designated as safety issue: No ]
    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).


Enrollment: 48
Study Start Date: January 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: protein (elderly) Other: protein
20g protein
Experimental: protein and carbohydrate (elderly) Other: protein and carbohydrate
20g protein and 20g carbohydrate
Experimental: protein and carbohydrate (young) Other: protein and carbohydrate
20g protein and 20g carbohydrate
Experimental: protein and leucine (elderly) Other: protein and leucine
20g protein, 2.5g leucine

  Eligibility

Ages Eligible for Study:   70 Years to 85 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01239277

Locations
Netherlands
Universiteit Maastricht, Bewegingswetenschappen
Maastricht, Limburg, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: A. de Lange Maastricht University Medical Center
  More Information

Additional Information:
Information about research performed by the Maastricht Muscle Metabolism group at MUMC  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01239277     History of Changes
Other Study ID Numbers: MEC 10-3-080
Study First Received: November 10, 2010
Last Updated: September 13, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
muscle
FSR
protein
carbohydrate
leucine

ClinicalTrials.gov processed this record on May 16, 2013