Tryptophan Requirement of Healthy School Age Children

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: tryptophan

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 Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G1X8
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 10 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy children age 6-10 inclusive

Exclusion Criteria:

• significant recent illness

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tryptophan intake; Graded levels of tryptophan will be given to each subject on different study days around the anticipated breakpoint.	Dietary supplement: tryptophan; graded levels of tryptophan will be given to each subject

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children

Publications and helpful links

General Publications

• Al-Mokbel A, Courtney-Martin G, Elango R, Ball RO, Pencharz PB, Tomlinson C. Tryptophan Requirement in School-Age Children Determined by the Indicator Amino Acid Oxidation Method is Similar to Current Recommendations. J Nutr. 2019 Feb 1;149(2):280-285. doi: 10.1093/jn/nxy250.

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: December 17, 2013
• First Submitted That Met QC Criteria: December 17, 2013
• First Posted (Estimate): December 23, 2013

Study Record Updates

• Last Update Posted (Actual): February 9, 2018
• Last Update Submitted That Met QC Criteria: February 7, 2018
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: amino acid; tryptophan; requirements
• Additional Relevant MeSH Terms: Psychotropic Drugs; Antidepressive Agents; Antidepressive Agents, Second-Generation; Tryptophan
• Other Study ID Numbers: 0019850580T

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO