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Clinical Trials/NCT02095080
NCT02095080
Completed
Not Applicable

Determination of the Tolerable Upper Intake Level (UL) of Leucine in Healthy Elderly Men (70-75 Yrs)

University of British Columbia1 site in 1 country6 target enrollmentAugust 2014
ConditionsElderly Men

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Elderly Men
Sponsor
University of British Columbia
Enrollment
6
Locations
1
Primary Endpoint
13 carbon dioxide production
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2014
End Date
December 2015
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rajavel Elango, PhD

Principle Investigator

University of British Columbia

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

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.

Study Sites (1)

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