Clinical trial NCT02095080: Determination of the UL of Leucine in Healthy Elderly Men
Official title: Determination of the Tolerable Upper Intake Level (UL) of Leucine in Healthy Elderly Men (70-75 Yrs)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly Men
Keywords: Leucine
Upper Intake Level (UL)
Elderly
Amino acids
Protein
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: International Council on Amino Acid Science
First posted: 2014-03-24
Enrollment: 6
Sex: MALE
Minimum age (years): 70
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: 13 carbon dioxide production
timeFrame: 8 hours (1 study day)
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Child & Family Research Institute
state: British Columbia
Study officials:
affiliation: Child & Family Research Institute/University of British Columbia
name: Rajavel Elango, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rasmussen B, Gilbert E, Turki A, Madden K, Elango R. Determination of the safety of leucine supplementation in healthy elderly men. Amino Acids. 2016 Jul;48(7):1707-16. doi: 10.1007/s00726-016-2241-0. Epub 2016 Apr 30.