Determination of the UL of Leucine in Healthy Elderly Men

Study Overview
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Brief Summary
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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.

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

Conditions
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Elderly Men

Intervention / Treatment
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* Dietary Supplement: Leucine intake


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Leucine intake<br>Dietary supplement: Leucine intake | Dietary Supplement: Leucine intake<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Leucine, Upper Intake Level (UL), Elderly, Amino acids, Protein