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Clinical Trials/NCT02095080
NCT02095080CompletedNot 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 enrollmentStarted: August 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
6
Locations
1
Primary Endpoint
13 carbon dioxide production

Study 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
70 Years to 75 Years (Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

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

Arms & Interventions

Leucine intake

Experimental

Dietary supplement: Leucine intake

Intervention: Leucine intake (Dietary Supplement)

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Rajavel Elango, PhD

Principle Investigator

University of British Columbia

Study Sites (1)

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