Determination of the UL of Leucine in Healthy Elderly Men

Elderly Men Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02095080
• Other study ID #: H14-00235
• Status: Completed
• Phase: N/A
• First received: March 19, 2014
• Last updated: July 13, 2017
• Start date: August 2014
• Est. completion date: December 2015

Study information

• Verified date: July 2017
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 70 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Elderly Men

Intervention

Dietary Supplement:
• Leucine 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.

Locations

Country	Name	City	State
Canada	Child & Family Research Institute	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	International Council on Amino Acid Science

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	13 carbon dioxide production	Urine, plasma and breath samples will be collected during the study to measure the rate of oxidation of the tracer.	8 hours (1 study day)