Determination of the UL of Leucine in Healthy Elderly Men

NCT02095080 | Completed DMC

• 1 other identifier: H14-00235
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Elderly Men

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

Leucine intake

EXPERIMENTAL

Dietary supplement: Leucine intake

Dietary Supplement: Leucine intake

Interventions

Leucine intake DIETARY_SUPPLEMENT

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.

Leucine intake

Eligibility Criteria

• Age: 70 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• International Council on Amino Acid Science: collaborator

Study Sites (1)

Child & Family Research Institute

Vancouver, British Columbia, V5Z 4H4, Canada

Location

Related Publications (1)

• 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.

  PMID: 27138628 DERIVED

Study Officials

• Rajavel Elango, PhD

  Child & Family Research Institute/University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: March 19, 2014
• First Posted: March 24, 2014
• Study Start: August 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 18, 2017

Record last verified: 2017-07

Locations

CA (1)