Length of Adaptation and Threonine Requirement

NCT04585087 | Completed

• 1 other identifier: 1000071242
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine if the body's needs for threonine (an amino acid which is an essential building block for protein) is different when assessed after 1, 3 or 6 days of adaptation to the level of threonine intake being studied.

Conditions

Healthy

Keywords

Healthy; Adult; Men; Threonine; Dietary Requirement

Outcome Measures

Primary Outcomes (1)

• Determination of threonine requirement in young adult men after 8 hours, 3, and 7 days of adaptation to experimental diets.

  The threonine requirement will be determined using IAAO and breakpoint analysis after 3 different lengths of adaptation to the experimental diet

  3 years

Study Arms (1)

Healthy adult men

EXPERIMENTAL

Participants will initially be seen for a pre-study assessment (2 hours). They will then be studied for up to 6 times (6 different levels of threonine intake). Each set of experiments will be 9-days in length. During the first 2 days, a pre-adaptation (milkshake) diet will be consumed. For the remaining 7 days, a protein liquid drink and protein-free cookies will be consumed. All of the diets will be provided by the investigators. During each 9-day experiment, participants are expected to come to the Clinical Research Centre at the Hospital for Sick Children for breath and urine collection (5 hours total for each visit)

Other: Dietary Intakes

Interventions

Dietary Intakes OTHER

6 levels of threonine intake will be provided by the protein liquid drink

Healthy adult men

Eligibility Criteria

• Age: 19 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult men, 19 to 35 years of age
• 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, hypo or hyperthyroidism, rheumatoid arthritis treated with anti-inflammatory medications).
• Non-smoking
• Willingness to consume the diet provided for 9 days

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. ≥ 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

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (1)

• Szwiega S, Pencharz PB, Ball RO, Xu L, Kong D, Elango R, Courtney-Martin G. Length of Adaptation Has No Effect on the Threonine Requirement Determined in Healthy Young Adult Males Using the Indicator Amino Acid Oxidation Method. J Nutr. 2023 Jul;153(7):2016-2026. doi: 10.1016/j.tjnut.2023.03.033. Epub 2023 Mar 31.

  PMID: 37004875 DERIVED

MeSH Terms

Conditions

Multiple Endocrine Neoplasia Type 1

Interventions

Eating

Condition Hierarchy (Ancestors)

Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

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: Health Systems Research Scientist

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 14, 2020
• Study Start: September 28, 2020
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: October 26, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)