Tryptophan Requirement of Healthy School Age Children

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: tryptophan

• Registration Number: NCT02018588
• Lead Sponsor: The Hospital for Sick Children

Brief Summary

Our objective is to determine the requirement for the amino acid tryptophan in school age children using the indicator amino acid technique.

Detailed Description

Seven healthy children will participate in the study. The children will participate as an outpatient basis with study days carried out in the Physiological Research Unit at the Hospital of Sick Children, Toronto, Canada. Inclusion criteria include: being healthy, not taking any medications, no recent weight changes, no history of significant illness, willing to participate in the study. Exclusion criteria were the presence of illness, significant weight change, not acceptance of the diet. Prior to enrolment, each subject will have to fill 3 days food record form to ensure his or her normal dietary behavior. The study will be explained to subjects and their parents/guardians, benefits and potential risks will be explained as well and written assent, from the children, and consent from parents will be obtained. Subjects will receive financial compensations. Each subject will receive compensation for participation. Each parent/guardian will be reimbursed for the transpiration/parking expenses and a meal each study day.

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-17
• Study First Submitted QC: 2013-12-17
• Study First Posted: 2013-12-23
• Status Verified: 2017-04
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Last Update Submitted: 2018-02-07
• Last Update Posted: 2018-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• Healthy children age 6-10 inclusive

Exclusion Criteria

• significant recent illness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
tryptophan intake	tryptophan	Graded levels of tryptophan will be given to each subject on different study days around the anticipated breakpoint.

Primary Outcome Measures

Name	Time	Method
Requirement of tryptophan in school age children	4 hours	By collection of stable isotope labeled CO2 from the indicator amino acid phenylalanine in response to different intake levels of tryptophan we will be able to determine tryptophan requirements.

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada