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Determination of the UL of Leucine in Healthy Elderly Men

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02095080
Enrollment
6
Registered
2014-03-24
Start date
2014-08-31
Completion date
2015-12-31
Last updated
2017-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elderly Men

Keywords

Leucine, Upper Intake Level (UL), Elderly, Amino acids, Protein

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.

Interventions

DIETARY_SUPPLEMENTLeucine 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.

Sponsors

International Council on Amino Acid Science
CollaboratorOTHER
University of British Columbia
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
70 Years to 75 Years
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

Design outcomes

Primary

MeasureTime frameDescription
13 carbon dioxide production8 hours (1 study day)Urine, plasma and breath samples will be collected during the study to measure the rate of oxidation of the tracer.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026