- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07272668
MA of Tryptophan in Cornmeal in Healthy Adults>60y
November 26, 2025 updated by: Glenda Courtney-Martin, The Hospital for Sick Children
Metabolic Availability of Tryptophan in Cornmeal in Healthy Adults >60 Yrs
The world's population will reach 12 billion by this century's end.
As the human population increases, the world faces the continuous challenge of optimizing a limited food supply.
Protein is the key determinant of growth and bodily function.
Recently, our group showed that current protein recommendations for adults and children are underestimated by 30-50%.
Animal protein production is "more resource intensive than any other form of food production" and their high saturated fat content is linked to chronic diseases in developed nations.
Plant protein sources are important alternatives shown to "enhance ecosystem resilience and improve human health".
Maize, commonly known as corn, is a staple food in the diets of more than 300 million Africans and ranks as the third most produced food globally.
Maize supplies up to 80% of daily energy in sub-Saharan and Southern Africa alone.
It is one of the main protein sources in these countries for vegetarians.
Already, over 900,000 Canadians adults are vegetarians and globally plant protein consumption is encouraged.
However, maize protein is limiting in the essential amino acid (EAA) tryptophan and anti-nutritional factors can affect tryptophan bioavailability (BA).
Dietary protein quality (DPQ) depends on its amino acid (AA) composition and BA.
Therefore, knowledge of tryptophan BA is fundamental to understand the extent to which cereal grains meet the body's requirement for protein synthesis (PS).
Efforts aimed at increasing crop production and DPQ, should coincide with DPQ evaluation directly in humans so that the gap in knowledge between protein requirement and how best to provide it can be quickly and efficiently reconciled.
Study Overview
Status
Enrolling by invitation
Intervention / Treatment
Detailed Description
Protein quality evaluation assesses the capacity of food proteins to meet the EAA needs of the body.
The DPQ of plant proteins have been little studied in humans despite their importance in the diet and their well-recognized positive effects on chronic diseases.
Dietary guidelines are encouraging increased plant protein consumption due to the benefits of plant protein.
With the increasing interest in vegetarian diets in North America, it is imperative that the DPQ of cereal grains be evaluated so that plant protein recommendations are accompanied by an empirical understanding of plant protein quality.
The information gathered from this project will provide additional experimental data in humans on plant protein quality (have completed lentils and chickpeas), on which nutrition recommendations can be built.
Globally, this will also help support the FAO's commitment to compile tables on AABA of foods for global distribution.
The aim of the study is to apply the IAAO method to determine the MA of tryptophan in maize prepared by moist cooking method.
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
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Toronto, Ontario, Canada, M5G 1X8
- The Hospital for Sick Children
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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: MA of tryptophan in maize
Apply the IAAO method to determine the metabolic availability of tryptophan in maize prepared by moist cooking method
|
4 different tryptophan test levels 0.5, 1, 1.5 and 2 mg.kg-1.day.1
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
MA of tryptophan in maize
Time Frame: Up to 24 months
|
To measure the tryptophan metabolic availability 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
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Glenda Courtney Martin, PhD, RD, The Hospital for Sick Children
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
November 29, 2025
Primary Completion (Estimated)
March 1, 2026
Study Completion (Estimated)
May 2, 2026
Study Registration Dates
First Submitted
November 26, 2025
First Submitted That Met QC Criteria
November 26, 2025
First Posted (Estimated)
December 9, 2025
Study Record Updates
Last Update Posted (Estimated)
December 9, 2025
Last Update Submitted That Met QC Criteria
November 26, 2025
Last Verified
October 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3568
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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