Determination of the UL of Leucine in Healthy Elderly Men

Not Applicable

Completed

• Conditions: Elderly Men
• Interventions: Dietary Supplement: Leucine intake

• Registration Number: NCT02095080
• Lead Sponsor: University of British Columbia

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-19
• Study First Submitted QC: 2014-03-20
• Study First Posted: 2014-03-24
• Study Start: 2014-08
• Primary Completion: 2015-06
• Study Completion: 2015-12
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-13
• Last Update Posted: 2017-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

Inclusion Criteria

• Men 70 - 75 years of age
• Free of chronic diseases including; sarcopenia, heart disease, kidney disorders, liver disease, chronic high blood pressure and or diabetes.
• Free of any cognitive disorders
• Men not enrolled in any other research studies
• Men who are not claustrophobic

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Exclusion Criteria

• Men not within the age 70 -75 years
• Men diagnosed with a chronic diseases including; sarcopenia, heart disease, kidney disorders, liver disease, chronic high blood pressure and/or diabetes
• Men allergic to milk, eggs and egg protein
• Men who are claustrophobic
• Men who are currently enrolled in other research studies

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Leucine intake	Leucine intake	Dietary supplement: Leucine intake

Primary Outcome Measures

Name	Time	Method
13 carbon dioxide production	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.

Trial Locations

Locations (1)

Child & Family Research Institute; 🇨🇦 Vancouver, British Columbia, Canada