Requirement for Leucine in Adults Over 60 Years

NCT03506126 | Completed

• 1 other identifier: 1000059679
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine the requirement for leucine, an essential amino acid, in adults over the age of 60 years. It is known that protein and amino acid metabolism may be altered with age and leucine, in particular, may be important in the diet of older adults. Eight different levels of leucine intake will be tested in each subject in random order. Each level of leucine intake will involve a 3-day maintenance diet, with measures being collected on the third.

Conditions

Healthy

Keywords

amino acid requirement; elderly; leucine; dietary requirement

Outcome Measures

Primary Outcomes (1)

• Determination of leucine requirement in adults over 60 y

  Rate of 13C-phenylalanine oxidation.

  3 years

Study Arms (1)

Leucine Adults > 60

EXPERIMENTAL

In this arm, all subjects will receive all 8 of the leucine test levels, assigned in random order.

Other: Leucine

Interventions

Leucine OTHER

There are 8 different leucine test levels ranging from 20 to 120 mg of leucine per kilogram body weight per day (20-120 mg/kg/d)

Leucine Adults > 60

Eligibility Criteria

• Age: 60 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy males \> 60 years
• Willingness to participate in the study and completed the screening procedures (height, weight, fasting blood sample and medical history questionnaire).
• No recent history of weight loss
• Absence of chronic disease or acute illness that could affect protein and AA metabolism (diabetes, cancer, liver or kidney disease, HIV, acute cold or flu, hypo or hyperthyroidism, rheumatoid arthritis treated with anti-inflammatory medications).
• Non-smoking
• Willingness to consume the diet provided

You may not qualify if:

• Presence of disease known to affect protein and AA metabolism (diabetes, cancer, liver or kidney disease, HIV, acute cold or flu, hypo or hyperthyroidism, rheumatoid arthritis treated with anti-inflammatory medications).
• On medications known to affect protein and amino acid metabolism (steroids).
• Recent significant weight loss.
• Individual on weight reducing diets.
• Inability to tolerate the diet
• Unwilling to have blood drawn from a venous access, or using a ventilated hood indirect calorimeter for the purposes of the study.
• Significant coffee consumption of more than 2 cups/day
• Significant alcohol consumption of more than one drink/day

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (1)

• Szwiega S, Pencharz PB, Rafii M, Lebarron M, Chang J, Ball RO, Kong D, Xu L, Elango R, Courtney-Martin G. Dietary leucine requirement of older men and women is higher than current recommendations. Am J Clin Nutr. 2021 Feb 2;113(2):410-419. doi: 10.1093/ajcn/nqaa323.

  PMID: 33330915 DERIVED

MeSH Terms

Interventions

Leucine

Intervention Hierarchy (Ancestors)

Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Officials

• Glenda Courtney-Martin, PhD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 13, 2018
• First Posted: April 23, 2018
• Study Start: April 17, 2018
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: February 2, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)