Healthy Clinical Trial - Threonine Requirement in Adults >60 Years of Age

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

To determine the threonine requirement in adults over the age of 60 years. With age, various physiological changes occur, including a decline in muscle and an increase in fat. Muscle reduction is a cause for concern as it may lead to weakness rendering regular daily activities more difficult. The muscles in the human body are composed of proteins and those proteins are made of small building blocks termed amino acids. The human body has the ability to make some amino acids which are called the non-essential amino acids. However, there are specific amino acids that the body needs to make protein, but can only be supplied from the foods eaten. These are termed essential amino acids. Threonine is one of the essential amino acids. It is needed to synthesize mucins which are proteins that protect the gastrointestinal tract from bacterial invasion. The body's capacity to make mucins is directly related to the bioavailability of amino acids like threonine. However, evidence from animal data has shown that older mice have compromised mucus function compared to young mice leaving them more susceptible to bacterial penetration. Thus, a higher dietary supply of threonine may be needed for maintaining intestinal mucosal health as individuals age. The purpose of this study is to find out the threonine requirement in adults over 60 years using the minimally invasive Indicator Amino Acid Oxidation (IAAO) method. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06225648
Study type	Interventional
Source	The Hospital for Sick Children
Contact	Alyssa Paoletti, PhD, MSc
Phone	4164207076
Email	alyssa..paoletti@sickkids.ca
Status	Recruiting
Phase	N/A
Start date	February 3, 2024
Completion date	February 1, 2025

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.