- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06283706
The Tryptophan Requirement in Healthy Adults
The Tryptophan Requirement in Healthy Adults Over 60 Years
The aging population is growing rapidly. For the first time ever, Canadian seniors outnumbered young adults in 2016. Aging is associated with many physical and metabolic deteriorations including the loss of muscle mass and strength, insulin resistance, increased inflammation and oxidative stress.
The muscles of our bodies are composed of proteins and proteins are made of small building blocks called amino acids. Our bodies have the ability to make some amino acids which are called the non-essential amino acids. However, there are certain amino acids that our body's need to make protein but can only be supplied from the foods that we consume. These are called essential amino acids. Tryptophan is one of the essential amino acids that the body needs. Tryptophan is required for protein synthesis and acts as a precursor for serotonin and nicotinic acid. Therefore, there may be a need for more threonine in the diet of older adults. However, the current requirement for threonine is based on studies conducted exclusively in young adults. Thus, the purpose of this study is to find out how much tryptophan older adults need.
Study Overview
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Zhiyao Wang, MSc
- Phone Number: 437 419 6224
- Email: zhiyao.wang@sickkids.ca
Study Contact Backup
- Name: Mahroukh Rafii, BSc
- Phone Number: 647 215 1201
- Email: mahroukh.rafii@sickkids.ca
Study Locations
-
-
Ontario
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Toronto, Ontario, Canada, M5G 1X8
- Recruiting
- Hospital for Sick Children
-
Contact:
- Glenda Courtney-Martin, PhD
- Phone Number: 416-814-5744
- Email: glenda.courtney-martin@sickkids.ca
-
-
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, 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: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Tryptophan in Adults >60y
Tryptophan levels, up to 7 levels, will be tested in a random order in all subjects
|
There are 7 different tryptophan test levels ranging from 0.5, 2, 4, 6, 8, 10, 12 mg.kg-1.day.1
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Determination of tryptophan requirement in adults >60 years of age.
Time Frame: up to 24 months
|
To measure the tryptophan 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 tryptophan are consumed by the participants consuming a controlled diet.
|
up to 24 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Glenda Courtney-Martin, 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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1000081113
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.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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