Determination of the UL of Leucine in Healthy Elderly Men
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|ClinicalTrials.gov Identifier: NCT02095080|
Recruitment Status : Completed
First Posted : March 24, 2014
Last Update Posted : July 18, 2017
Amino acid are the building blocks of the body's protein. Some amino acids, including leucine, cannot be made in the body and must be obtained from diet, these are called essential. With increase in age the body's muscle mass decrease and studies have suggested that dietary supplementation of leucine may have potential health benefits in elderly in regards to prevention of age related loss of lean muscle mass, and thus may help improve the quality of life in elderly.
Currently, a safe upper dietary intake level of leucine has not been established for healthy elderly. Prior to exploring whether leucine supplementation will prevent or decrease loss of lean muscle mass in elderly we propose to identify the upper intake of leucine in healthy elderly.
The purpose of this study is to determine the tolerable upper intake level (UL) of leucine in healthy elderly men (70 - 75 yrs)
The investigators hypothesize that with a careful graded stepwise increase in leucine intake in elderly men, above the Estimated Average Requirement (EAR - 50 mg/kg/d), the body's ability to oxidize/dispose of excess amino acids will reach a maximum. With increased leucine intakes we hypothesize an increase in plasma ammonia concentrations and increases in plasma leucine and urinary leucine excretion.
|Condition or disease||Intervention/treatment||Phase|
|Elderly Men||Dietary Supplement: Leucine intake||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Determination of the Tolerable Upper Intake Level (UL) of Leucine in Healthy Elderly Men (70-75 Yrs)|
|Study Start Date :||August 2014|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||December 2015|
Experimental: Leucine intake
Dietary supplement: Leucine intake
Dietary Supplement: Leucine intake
Oral consumption of eight hourly experimental meals- Includes 4 tracer-free experimental meals containing a mixture of free amino acids, calories from a flavored liquid and protein free cookies and 4- labeled amino acid experimental meals.
- 13 carbon dioxide production [ Time Frame: 8 hours (1 study day) ]Urine, plasma and breath samples will be collected during the study to measure the rate of oxidation of the tracer.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02095080
|Canada, British Columbia|
|Child & Family Research Institute|
|Vancouver, British Columbia, Canada, V5Z 4H4|
|Principal Investigator:||Rajavel Elango, PhD||Child & Family Research Institute/University of British Columbia|