Tryptophan Requirement of Healthy School Age Children

Healthy Clinical Trial

Official title:

Tryptophan Requirement of Healthy School Age Children Determined by the Indicator Amino Acid Oxidation Method

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02018588
• Other study ID #: 0019850580T
• Status: Completed
• Phase: N/A
• First received: December 17, 2013
• Last updated: February 7, 2018
• Start date: December 2013
• Est. completion date: December 2017

Study information

• Verified date: April 2017
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 10 Years

Eligibility

Inclusion Criteria:

• Healthy children age 6-10 inclusive

Exclusion Criteria:

• significant recent illness

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• tryptophan
graded levels of tryptophan will be given to each subject

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Requirement of tryptophan in school age children	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.	4 hours