NCT07272668

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

November 29, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 9, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2026

Completed
Last Updated

December 9, 2025

Status Verified

October 1, 2025

Enrollment Period

3 months

First QC Date

November 26, 2025

Last Update Submit

November 26, 2025

Conditions

Keywords

elderlyhealthytryptophanamino acid availabilitymetabolic availabilityindicator amino acid oxidationiaaostable isotopes

Outcome Measures

Primary Outcomes (1)

  • MA of tryptophan in maize

    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

Study Arms (1)

MA of tryptophan in maize

EXPERIMENTAL

Apply the IAAO method to determine the metabolic availability of tryptophan in maize prepared by moist cooking method

Other: Tryptophan

Interventions

4 different tryptophan test levels 0.5, 1, 1.5 and 2 mg.kg-1.day.1

Also known as: maize
MA of tryptophan in maize

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Interventions

Tryptophan

Intervention Hierarchy (Ancestors)

Amino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Essential

Study Officials

  • Glenda Courtney Martin, PhD, RD

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Scientist

Study Record Dates

First Submitted

November 26, 2025

First Posted

December 9, 2025

Study Start

November 29, 2025

Primary Completion

March 1, 2026

Study Completion

May 2, 2026

Last Updated

December 9, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations