Tryptophan Intake for Healthy Adults

Overseen By Nisha Pai, MSc, RD

Age: 18 - 65

Sex: Male

Trial Phase: Academic

Sponsor: The Hospital for Sick Children

Must not be taking: Steroids, Anti-inflammatories, SSRIs, others

Disqualifiers: Diabetes, Cancer, Liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 10 hours

6 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Tryptophan is an essential amino acid needed for growth and bodily functions. It is used to make serotonin which is needed for the brain to develop and function properly. However, when the body is stressed, tryptophan is broken down into compounds that can cause harm to the brain. Premature babies who get nutrition through their vein \[i.e. total parenteral nutrition (TPN)\] can experience this type of stress. The amount of tryptophan in TPN solutions is much higher than what premature babies need and can produce too much harmful compounds. So, it is important to study the amount of these compounds made from tryptophan. But there are no methods available to study this. Therefore, the goal of this study is to develop a method to measure the compounds made from tryptophan breakdown in adults so that it can be used for preterm babies on TPN later.

Who Is on the Research Team?

Glenda Courtney-Martin, PhD, RD

Principal Investigator

The Hospital for Sick Children

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My blood sugar and kidney function tests are within normal ranges.

I am in good health overall.

Consent provided

Exclusion Criteria

I am willing to have blood drawn and participate in all required study procedures.

I have a condition like diabetes, cancer, or liver disease that affects how my body uses proteins.

Inability to tolerate the diet (i.e. allergy)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive varying levels of tryptophan intake to study its metabolism

10 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tryptophan

Trial Overview 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.

How Is the Trial Designed?

Group I: Experimental: Tryptophan in healthy young adults (18-45 years) Experimental Treatment 1 Intervention

Tryptophan intake levels, up to 5 levels, will be tested in a random order in all subjects

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials

724

Recruited

6,969,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+