Leucine Requirement in Adult Men and Women

NCT05394155 | Completed

• 1 other identifier: 1000078896
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine the body's nutritional need for the essential amino acid, leucine, in adult men and women 18 to 39 years of age.

Conditions

Healthy

Keywords

Leucine; amino acid; nutrition; requirement

Outcome Measures

Primary Outcomes (1)

• F13CO2

  Rate of appearance of labelled carbon dioxide (13CO2) in breath from the oxidation of 13C-Phenylalanine

  4.5 hours during study visits

Secondary Outcomes (2)

• 13C-phenylalanine enrichment

  4.5 hours during study visits

• Plasma amino acid concentrations

  at end of each study visit

Study Arms (1)

Leucine intake

EXPERIMENTAL

For this study, each participant will be randomly assigned to receive up to 7 intake levels of leucine, ranging from 10 to 75 mg/kg/d.

Dietary Supplement: Leucine

Interventions

Leucine DIETARY_SUPPLEMENT

7 intake levels of leucine, ranging from 10 to 75 mg/kg/d.

Leucine intake

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult males, 18 to 39 years of age.
• Healthy adult females, 18 to 39 years of age with regular menstrual cycles within in the last 12 months.
• 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
• BMI between 18.5 - 27 kg/m 2
• 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, COVID-19, 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, Covid-19, hypo or hyperthyroidism, rheumatoid arthritis treated with anti-inflammatory medications).
• On medications known to affect protein and amino acid metabolism (steroids) or taking oral contraceptive pills or other birth control devices that would affect sex hormone profiles over the last 2 years.
• Pregnant or lactating women.
• Recent significant weight loss; ≥ 5% of body with in the last 3 months.
• Individuals 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
• Failure to disclose any of the information needed to assess eligibility.

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, Xu L, Kong D, Tomlinson C, Elango R, Courtney-Martin G. Leucine requirement determined in healthy young adult males using the indicator amino acid oxidation method. Am J Clin Nutr. 2024 Nov;120(5):1063-1070. doi: 10.1016/j.ajcnut.2024.08.022. Epub 2024 Aug 28.

  PMID: 39209155 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, RD

  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: Associate Scientist

Model Details: Repeated measures study design.

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: May 27, 2022
• Study Start: April 29, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)