- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00807508
Leucine Supplementation in Elderly Men
December 11, 2008 updated by: Maastricht University Medical Center
The Influence of Leucine Supplementation on Body Composition and Muscle Characteristics in Healthy Elderly
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Maastricht, Netherlands, 6200 MD
- Maastricht University Medical Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 85 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- living independently
Exclusion Criteria:
- Diabetes cardiovascular disease orthopedic limitations history of resistance training in past 5 years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
daily leucine supplementation
|
daily leucine capsules with each main meal
|
Placebo Comparator: 2
daily placebo supplementation
|
wheat meal capsules with each main meal
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
muscle mass and body composition
Time Frame: before and after 12 wk intervention
|
before and after 12 wk intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
muscle strength
Time Frame: before and after 12 wk intervention
|
before and after 12 wk intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (Actual)
December 1, 2007
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
December 11, 2008
First Submitted That Met QC Criteria
December 11, 2008
First Posted (Estimate)
December 12, 2008
Study Record Updates
Last Update Posted (Estimate)
December 12, 2008
Last Update Submitted That Met QC Criteria
December 11, 2008
Last Verified
December 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MEC 06-3-062A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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