Protein Requirements for Active Children (IAAO-C)

March 28, 2019 updated by: Daniel Moore

Evaluation of Protein Requirements in Active Children

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.

Study Overview

Status

Completed

Detailed Description

Provided energy needs are met, the adequate ingestion of dietary amino acids is the most critical nutritional factor to support the optimal remodeling and deposition of lean body mass in individuals of all ages, including active youth. Despite the fact that the most consistent and rapid growth velocities outside of infancy occur during childhood and adolescence, respectively, there is a paucity of research into the fundamental questions of how exercise and nutrition (i.e. dietary amino acid ingestion) enhance protein turnover in these key demographics. Of primary importance is the impact exercise has on the nutritional requirement for dietary amino acids in concurrently growing youth. This lack of dedicated research represents a significant knowledge gap for a large segment of the world's population. Nutritional requirements for dietary amino acids in young adults has traditionally been determined utilizing the antiquated and often erroneous nitrogen balance technique, which makes it difficult to adequately define the protein needs of this population, let alone those of children. In addition, nitrogen balance requires a prolonged adaptation period, which exposes subjects to deficient intakes for 7-10 days, making it unsuitable for use in vulnerable populations like children. As a result, there is a need to establish (in the case of children) recommendations utilizing advanced stable isotope methodology in order to characterize how dietary amino acid needs may be affected by physical activity over the critical early years of development.

Studies using the minimally invasive indicator amino acid oxidation (IAAO) technique have suggested that protein requirements in young men and children are at least 50% higher than WHO/FAO guidelines based on nitrogen balance data.

The present study will use, for the first time in active children, the gold-standard IAAO technique to achieve two major objectives: i) to determine the impact of high levels of physical activity on protein requirements in active, growing children, and; ii) to determine whether exercise in adolescence, previously determined in a separate study, alters protein requirements relative to similarly active children.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Toronto, Ontario, Canada, M5S 2C9
        • Goldring Centre for High Performance Sport

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active, Male and Female Children
Participants will receive different levels of amino acid intakes, varying from 0.2-2.67 g/kg/d
Amino acid intakes will be varied at 0.2-2.67 g/kg/d

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
13CO2 ([13]Carbon Dioxide) Excretion (µmol/kg/h)
Time Frame: 4 hours/study day
4 hours/study day

Secondary Outcome Measures

Outcome Measure
Time Frame
[13C]Phenylalanine Oxidation (µmol/kg/h)
Time Frame: 4 hours/study day
4 hours/study day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2016

Primary Completion (Actual)

October 31, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

May 19, 2017

First Submitted That Met QC Criteria

May 19, 2017

First Posted (Actual)

May 22, 2017

Study Record Updates

Last Update Posted (Actual)

March 29, 2019

Last Update Submitted That Met QC Criteria

March 28, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • IAAO-C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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