- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06225648
Threonine Requirement in Adults >60 Years of Age
The Threonine Requirement in Healthy Adults Over 60 Years
Study Overview
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mahroukh Rafii, BSc
- Phone Number: 416 813 7454
- Email: mahroukh.rafii@sickkids.ca
Study Contact Backup
- Name: Alyssa Paoletti, PhD, MSc
- Phone Number: 4164207076
- Email: alyssa..paoletti@sickkids.ca
Study Locations
-
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Ontario
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Toronto, Ontario, Canada, M5G 1X8
- Recruiting
- The Hospital for Sick Children
-
Contact:
- Alyssa Paoletti, BSc, MSc
- Phone Number: 416-813-5744
- Email: alyssa.paoletti@sickkids.ca
-
Contact:
- Mahroukh Rafii, BSc.
- Phone Number: 416-813-7454
- Email: mahroukh.rafii@sickkids.ca
-
Principal Investigator:
- Glenda Courtney-Martin, PhD, RD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Threonine in Adults > 60
Threonine: all subjects will receive up to 7 threonine test levels, in random order.
|
There are 7 different threonine test levels ranging from 5 to 45 mg of threonine per kilogram body weight per day.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
up to 24 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Glenda Courtney-Martin, MSc, PhD, RD, The Hospital for Sick Children
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1000081068
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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