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Leucine Supplementation in Elderly Men

This study has been completed.
Sponsor:
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00807508
First received: December 11, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  Purpose

In the present study the investigators aim to determine whether leucine supplementation can augment muscle mass and strength and improve body composition in healthy elderly men


Condition Intervention Phase
Sarcopenia
Atrophy
Aging
 Dietary Supplement: placebo
Dietary Supplement: leucine
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Influence of Leucine Supplementation on Body Composition and Muscle Characteristics in Healthy Elderly

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 mass and body composition [ Time Frame: before and after 12 wk intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • muscle strength [ Time Frame: before and after 12 wk intervention ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: January 2007
Study Completion Date: December 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
daily leucine supplementation
 Dietary Supplement: leucine
daily leucine capsules with each main meal
Placebo Comparator: 2
daily placebo supplementation
 Dietary Supplement: placebo
wheat meal capsules with each main meal

  Eligibility

Ages Eligible for Study:   65 Years to 85 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • living independently

Exclusion Criteria:

  • Diabetes cardiovascular disease orthopedic limitations history of resistance training in past 5 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00807508

Locations
Netherlands
Maastricht University Medical Centre
Maastricht, Netherlands, 6200 MD
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Luc JC van Loon, PhD Maastricht University Medical Center
  More Information

No publications provided by Maastricht University Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Luc JC van Loon, PhD, MaastrichtUMC
ClinicalTrials.gov Identifier: NCT00807508     History of Changes
Other Study ID Numbers: MEC 06-3-062A
Study First Received: December 11, 2008
Last Updated: December 11, 2008
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Atrophy
Sarcopenia
Pathological Conditions, Anatomical
Muscular Atrophy
 Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013