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Determination of the UL of Leucine in Healthy Elderly Men

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ClinicalTrials.gov Identifier: NCT02095080
Recruitment Status : Completed
First Posted : March 24, 2014
Last Update Posted : July 18, 2017
Sponsor:
Collaborator:
International Council on Amino Acid Science
Information provided by (Responsible Party):
Rajavel Elango, PhD, University of British Columbia

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.


Condition or disease Intervention/treatment Phase
Elderly Men Dietary Supplement: Leucine intake Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Determination of the Tolerable Upper Intake Level (UL) of Leucine in Healthy Elderly Men (70-75 Yrs)
Study Start Date : August 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Leucine

Arm Intervention/treatment
Experimental: Leucine intake
Dietary supplement: Leucine intake
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.




Primary Outcome Measures :
  1. 13 carbon dioxide production [ Time Frame: 8 hours (1 study day) ]
    Urine, plasma and breath samples will be collected during the study to measure the rate of oxidation of the tracer.



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Ages Eligible for Study:   70 Years to 75 Years   (Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02095080


Locations
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Canada, British Columbia
Child & Family Research Institute
Vancouver, British Columbia, Canada, V5Z 4H4
Sponsors and Collaborators
University of British Columbia
International Council on Amino Acid Science
Investigators
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Principal Investigator: Rajavel Elango, PhD Child & Family Research Institute/University of British Columbia

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rajavel Elango, PhD, Principle Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT02095080     History of Changes
Other Study ID Numbers: H14-00235
First Posted: March 24, 2014    Key Record Dates
Last Update Posted: July 18, 2017
Last Verified: July 2017

Keywords provided by Rajavel Elango, PhD, University of British Columbia:
Leucine
Upper Intake Level (UL)
Elderly
Amino acids
Protein