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Tryptophan Intake for Healthy Adults

N/A
Waitlist Available
Led By Glenda Courtney-Martin, PhD, RD
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 18 to 45 years old (inclusive)
Fasting blood glucose, hemoglobin A1c (HbA1c), urea, creatinine and CRP levels within normal ranges for age.
Must not have
Unwilling to have blood drawn from a venous access or using a ventilated hood indirect calorimeter for the purposes of the study.
Taking medications known to affect protein/AA metabolism (e.g. steroids, anti-inflammatory medications, acetaminophen, selective serotonin reuptake inhibitors (SSRI))
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 hours
Awards & highlights

Summary

This trial aims to develop a method to measure harmful compounds produced from the breakdown of tryptophan in adults, which can be used to help premature babies receiving total parenteral nutrition (TPN)

Who is the study for?
This trial is for healthy young adults. Specific eligibility criteria are not provided, but typically participants should have no significant health issues that could interfere with the study.
What is being tested?
The study aims to develop a method to measure compounds resulting from tryptophan breakdown. This will help understand its metabolism in stressed conditions like those experienced by premature babies on TPN.
What are the potential side effects?
Since this trial involves monitoring tryptophan intake in healthy individuals, side effects are expected to be minimal or related to potential dietary changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 45 years old.
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My blood sugar and kidney function tests are within normal ranges.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am willing to have blood drawn and participate in all required study procedures.
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I am not taking steroids, anti-inflammatories, acetaminophen, or SSRIs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Fractional Synthesis Rate (FSR) of tryptophan metabolites
Steady state
Secondary study objectives
Fractional synthesis rate (FSR)
Partitioning of tryptophan metabolism

Side effects data

From 2019 Phase 2 & 3 trial • 93 Patients • NCT02067975
19%
Nausea
11%
Vomiting
6%
Dizziness
6%
Sedation
3%
Syncope
3%
Headache
3%
Drowsniess
3%
Abdominal Pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Healthy Control: Tryptophan
Schizophrenia Related Disorders: Tryptophan
Healthy Controls: Placebo
Schizophrenia Related Disorders: Screening
Schizophrenia Related Disorders: Placebo
Healthy Controls: Screening

Trial Design

1Treatment groups
Experimental Treatment
Group I: Experimental: Tryptophan in healthy young adults (18-45 years)Experimental Treatment1 Intervention
Tryptophan intake levels, up to 5 levels, will be tested in a random order in all subjects

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor
704 Previous Clinical Trials
6,956,871 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,373 Previous Clinical Trials
26,519,236 Total Patients Enrolled
Glenda Courtney-Martin, PhD, RDPrincipal InvestigatorThe Hospital for Sick Children
5 Previous Clinical Trials
192 Total Patients Enrolled
~4 spots leftby Dec 2024
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