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Protein Supply in Elderly

This study has been completed.
Sponsor:
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01317511
First received: March 16, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Muscle Synthesis
 Dietary Supplement: Protein

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Overnight Protein Supply as a Dietary Strategy to Improve Muscle Mass in Elderly.

Resource links provided by NLM:

MedlinePlus related topics: Drinking Water
U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Protein synthesis [ Time Frame: overnight (12 h) ] [ Designated as safety issue: No ]
    Overnight protein synthesis


Enrollment: 16
Study Start Date: June 2010
Study Completion Date: February 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Protein
Protein drink
 Dietary Supplement: Protein
Protein drink
Other Name: casein vs water
Placebo Comparator: Placebo
water
 Dietary Supplement: Protein
Protein drink
Other Name: casein vs water

  Eligibility

Ages Eligible for Study:   65 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01317511

Locations
Netherlands
Maastricht University Medical Centre
Maastricht, Limburg, Netherlands, 6229ER
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Luc van Loon, Prof. Maastricht UMC
  More Information

No publications provided

Responsible Party: Prof. LJC van Loon, MaastrichtUMC
ClinicalTrials.gov Identifier: NCT01317511     History of Changes
Other Study ID Numbers: MEC 09-3-078.3
Study First Received: March 16, 2011
Last Updated: March 16, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

ClinicalTrials.gov processed this record on June 18, 2013