Back to resultsLeucine Supplementation in Elderly Men
Primary Purpose
Sarcopenia, Atrophy, Aging
Status
Completed
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
placebo
leucine
Sponsored by
About this trial
This is an interventional treatment trial for Sarcopenia
Eligibility Criteria
Inclusion Criteria:
- living independently
Exclusion Criteria:
- Diabetes cardiovascular disease orthopedic limitations history of resistance training in past 5 years
Sites / Locations
- Maastricht University Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
daily leucine supplementation
daily placebo supplementation
Outcomes
Primary Outcome Measures
muscle mass and body composition
Secondary Outcome Measures
muscle strength
Full Information
NCT ID
NCT00807508
First Posted
December 11, 2008
Last Updated
December 11, 2008
Sponsor
Maastricht University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00807508
Brief Title
Leucine Supplementation in Elderly Men
Official Title
The Influence of Leucine Supplementation on Body Composition and Muscle Characteristics in Healthy Elderly
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Maastricht University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia, Atrophy, Aging
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
daily leucine supplementation
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
daily placebo supplementation
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
wheat meal capsules with each main meal
Intervention Type
Dietary Supplement
Intervention Name(s)
leucine
Intervention Description
daily leucine capsules with each main meal
Primary Outcome Measure Information:
Title
muscle mass and body composition
Time Frame
before and after 12 wk intervention
Secondary Outcome Measure Information:
Title
muscle strength
Time Frame
before and after 12 wk intervention
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
living independently
Exclusion Criteria:
Diabetes cardiovascular disease orthopedic limitations history of resistance training in past 5 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luc JC van Loon, PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Centre
City
Maastricht
ZIP/Postal Code
6200 MD
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
19321567
Citation
Verhoeven S, Vanschoonbeek K, Verdijk LB, Koopman R, Wodzig WK, Dendale P, van Loon LJ. Long-term leucine supplementation does not increase muscle mass or strength in healthy elderly men. Am J Clin Nutr. 2009 May;89(5):1468-75. doi: 10.3945/ajcn.2008.26668. Epub 2009 Mar 25.
Results Reference
derived
Learn more about this trial
Leucine Supplementation in Elderly Men
We'll reach out to this number within 24 hrs