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Completed

NCT Number: NCT02095080

Determination of the UL of Leucine in Healthy Elderly Men

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.

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Key information

Conditions

Elderly Men

Age range

70 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Child & Family Research Institute

Vancouver, British Columbia, V5Z 4H4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • International Council on Amino Acid Science

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 24, 2014
Registry last updated
Jul 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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