Threonine Requirement in Adults >60 Years of Age

NCT06225648 | Recruiting

• 1 other identifier: 1000081068
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Threonine is an essential amino acid and must be obtained from the diet. The body's capacity to maintain adequate mucin synthesis is directly related to the bioavailability of certain amino acids, including threonine, serine and proline (1). Moreover, the rate of mucin synthesis has been demonstrated to be directly related to the availability of dietary threonine in healthy rats (2) and piglets (3,4). Intestinal inflammation is known to increase gastrointestinal threonine uptake and mucin synthesis in enterally fed minipigs (5). Additionally, in animals, mucin function/barrier has been shown to decline with age, leaving them more susceptible to bacterial penetration. Thus, with advancing age (6), a higher dietary supply of threonine may be needed for maintaining intestinal mucosal health. Despite this, the current threonine requirement is based on studies conducted exclusively in young adults. Thus, there is a need to determine the threonine requirement directly in older adults.

Conditions

Healthy; Aging

Keywords

elderly; healthy; threonine requirement; indicator amino acid oxidation; stable isotopes

Outcome Measures

Primary Outcomes (1)

• Determination of threonine requirements in adults >60 years of age

  To measure the threonine requirement investigators will collect breath samples from participants. From these samples, investigators will measure the amount of amino acids oxidized and how much is retained in the body when graded intakes of threonine are consumed by the participants consuming a controlled diet.

  up to 24 months

Study Arms (1)

Threonine in Adults > 60

EXPERIMENTAL

Threonine: all subjects will receive up to 7 threonine test levels, in random order.

Other: threonine

Interventions

threonine OTHER

There are 7 different threonine test levels ranging from 5 to 45 mg of threonine per kilogram body weight per day.

Threonine in Adults > 60

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consent provided
• Aged 60 to 90 years old
• In good general health as evidenced by medical history, physical health and blood draw
• Fasting blood glucose, hemoglobin A1c (HbA1c), urea, creatinine
• Willingness to participate in the study.
• BMI \<30 kg/m2.

You may not qualify if:

• Presence of chronic disease and/or acute illness known to affect protein/amino acid metabolism (e.g. HIV, diabetes, cancer, liver or kidney disease, acute cold or flu)
• Taking medications known to affect protein/AA metabolism (e.g. steroids)
• Inability to tolerate the diet (i.e. allergy)
• Significant weight loss during the past month or consumption of weight reducing diets.
• Significant caffeine consumption (\>2 cups per day)
• Significant consumption of alcohol (\>1 drink per day i.e. 1 beer or ½ glass of wine).
• Unwilling to have blood drawn from a venous access, or using a ventilated hood indirect calorimeter for the purposes of the study.

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

RECRUITING

MeSH Terms

Interventions

Threonine

Intervention Hierarchy (Ancestors)

Amino Acids, Essential; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Neutral

Study Officials

• Glenda Courtney-Martin, MSc, PhD, RD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alyssa Paoletti, PhD, MSc

CONTACT

4164207076; alyssa..paoletti@sickkids.ca

Mahroukh Rafii, BSc

CONTACT

416 813 7454; mahroukh.rafii@sickkids.ca

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: Senior Associate Scientist

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: January 26, 2024
• Study Start: February 3, 2024
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)