HealthyNCT06225648
Threonine Requirement in Adults >60 Years of Age
A study testing threonine in people with Healthy and Aging, run by The Hospital for Sick Children at 1 site in Canada.
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). Read more about this study
- Who is it for?
- Ages 60 to 90 yearsHealthy volunteers can take part
- What is being tested?
- threonine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 3 Feb 2024to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Alyssa Paoletti, BSc, MSc, 416-813-5744, alyssa.paoletti@sickkids.ca
Mahroukh Rafii, BSc., 416-813-7454, mahroukh.rafii@sickkids.ca
About this study
Official title: The Threonine Requirement in Healthy Adults Over 60 Years
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.
Read the detailed 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.
- Being tested
- threonine
- Keywords
- elderly, healthy, threonine requirement, indicator amino acid oxidation, stable isotopes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
threonineOther
There are 7 different threonine test levels ranging from 5 to 45 mg of threonine per kilogram body weight per day.
| Study group | Role | What they receive |
|---|---|---|
| Threonine in Adults > 60 | Experimental | Threonine: all subjects will receive up to 7 threonine test levels, in random order. Receives: Other: threonine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start3 Feb 2024
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Glenda Courtney-Martin, The Hospital for Sick Children
- Investigators
- Glenda Courtney-Martin, MSc, PhD, RD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06225648
- Sponsor's protocol ID
- 1000081068
- Status last verified
- May 2025
- First submitted
- 16 Jan 2024
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Paoletti A, Naeem W, Pencharz PB, Tomlinson C, Rafii M, Kong D, Li B, Elango R, Courtney-Martin G. Dietary threonine requirement of healthy older adults >60y stratified by age and sex in a repeated measures design1. Am J Clin Nutr. 2026 Oct 31:101619. doi: 10.1016/j.ajcnut.2026.101619. Online ahead of print.
PubMed 42966566
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Threonine Requirement in Healthy Adults Over 60 Years
- ClinicalTrials.gov ID
- NCT06225648
- Acronym / sponsor ID
- 1000081068
- Keywords
- elderly, healthy, threonine requirement, indicator amino acid oxidation, stable isotopes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 3 Feb 2024 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 26 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Threonine in Adults > 60 | Experimental | Other: threonineThreonine: all subjects will receive up to 7 threonine test levels, in random order. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| threonineThere are 7 different threonine test levels ranging from 5 to 45 mg of threonine per kilogram body weight per day. | Other | Threonine in Adults > 60 |
Primary outcome
Determination of threonine requirements in adults >60 years of age
Time frame: up to 24 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Derived from this study: PubMed 42966566Paoletti A, Naeem W, Pencharz PB, Tomlinson C, Rafii M, Kong D, Li B, Elango R, Courtney-Martin G. Dietary threonine requirement of healthy older adults >60y stratified by age and sex in a repeated measures design1. Am J Clin Nutr. 2026 Oct 31:101619. doi: 10.1016/j.ajcnut.2026.101619. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Glenda Courtney-Martin, MSc, PhD, RD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing threonine in people with Healthy and Aging, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alyssa Paoletti, PhD, MSc (4164207076, alyssa..paoletti@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of threonine requirements in adults >60 years of age (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06225648, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.