Tryptophan Requirement of Healthy School Age Children

NCT ID: NCT02018588

Last Updated: 2018-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2017-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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tryptophan intake

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

Group Type EXPERIMENTAL

tryptophan

Intervention Type DIETARY_SUPPLEMENT

graded levels of tryptophan will be given to each subject

Interventions

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tryptophan

graded levels of tryptophan will be given to each subject

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Healthy children age 6-10 inclusive

Exclusion Criteria

* significant recent illness
Minimum Eligible Age

6 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

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Dr. Paul Pencharz

Professor of Paediatrics and Nutritional Sciences (Emeritus) University of Toronto, Senior Scientist Research Institute, The Hospital for Sick Children

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paul B Pencharz, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children, Toronto, Canada

Locations

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The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 30753549 (View on PubMed)

Other Identifiers

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0019850580T

Identifier Type: -

Identifier Source: org_study_id

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