NCT03163043

Brief Summary

Nutritional requirements for dietary amino acids in children have traditionally been determined utilizing the nitrogen balance technique, which is prone to underestimating protein requirements. As a result, there is a need to re-evaluate recommendations in order to characterize how dietary amino acid needs may be modulated by physical activity in healthy, active children. The purpose of this study is to measure the protein requirement in children (boys and girls) using the IAAO technique in the presence of a variable intensity exercise stimulus. It is hypothesized that the present study will deem current amino acid requirements to be underestimates of appropriate amino acid requirements for this population.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 22, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 22, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

March 29, 2019

Status Verified

March 1, 2019

Enrollment Period

1 year

First QC Date

May 19, 2017

Last Update Submit

March 28, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 13CO2 ([13]Carbon Dioxide) Excretion (µmol/kg/h)

    4 hours/study day

Secondary Outcomes (1)

  • [13C]Phenylalanine Oxidation (µmol/kg/h)

    4 hours/study day

Study Arms (1)

Active, Male and Female Children

EXPERIMENTAL

Participants will receive different levels of amino acid intakes, varying from 0.2-2.67 g/kg/d

Dietary Supplement: Amino Acid Intake

Interventions

Amino Acid IntakeDIETARY_SUPPLEMENT

Amino acid intakes will be varied at 0.2-2.67 g/kg/d

Active, Male and Female Children

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy, active children who regularly participates in moderate to vigorous physical activity 5 times a week for a minimum of 1 hour.
  • Biological age less than or equal to -1.0 years from Peak Height Velocity (PHV), determined by the ratio of standing to sitting height
  • An age and sex-specific minimum performance level on the Beep Test

You may not qualify if:

  • Inability to meet health and physical activity guidelines according to the PAR-Q+ and Physical Activity Questionnaire
  • Inability to adhere to any of the protocol guidelines (i.e., caffeine consumption)
  • Biological age greater than -1.0 years from PHV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Goldring Centre For High Performance Sport

Toronto, Ontario, M5S 2C9, Canada

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. Daniel Moore, Assistant Professor

Study Record Dates

First Submitted

May 19, 2017

First Posted

May 22, 2017

Study Start

October 22, 2016

Primary Completion

October 31, 2017

Study Completion

December 31, 2017

Last Updated

March 29, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations