NCT02859181

Brief Summary

Protein requirements in active individuals have been suggested to be greater than the current recommended dietary allowance (RDA). Nutritional requirements for dietary amino acids in adolescents 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. Recent studies using the minimally invasive indicator amino acid oxidation (IAAO) technique have suggested that protein requirements in young men are at least 50% higher than the RDA based on nitrogen balance data. The purpose of this study is to measure the protein requirement in adolescent, males using the IAAO technique in the presence of a variable intensity exercise stimulus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable healthy

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

First Submitted

Initial submission to the registry

June 10, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 8, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
Last Updated

March 29, 2019

Status Verified

March 1, 2019

Enrollment Period

1.1 years

First QC Date

June 10, 2016

Last Update Submit

March 28, 2019

Conditions

Keywords

Increased Metabolic Requirement

Outcome Measures

Primary Outcomes (1)

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

    Each trial day will assess a different protein intake with 13CO2 excretion defining the level of protein adequacy. Each trial day will be separated by \~1wk washout with all trial being completed in approximately 3 months.

    4 hours per study day

Secondary Outcomes (1)

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

    4 hours per study day

Study Arms (1)

Active, Adolescent males

EXPERIMENTAL

Subjects 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, Adolescent males

Eligibility Criteria

Age10 Years - 15 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy, active adolescent who regularly participates in moderate to vigorous physical activity 5 times a week for a minimum of 1 hour.
  • Being -0.5 to +1.0 years from peak height velocity, determined by the ratio of standing to sitting height, with the maximal age for adolescents being 16 years.
  • Obtaining a minimum level of 8.3 on the Beep Test

You may not qualify if:

  • Inability to meet health and physical activity guidelines according to the Physical activity readiness questionnaire (PAR-Q+) and Physical Activity Questionnaire,
  • an inability to adhere to any of the protocol guidelines (i.e. caffeine consumption)
  • a biological age falling outside of the aforementioned ranges

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Goldring Centre for High Performance Sport

Toronto, Ontario, M5S2C9, Canada

Location

Study Officials

  • Daniel Moore, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 10, 2016

First Posted

August 8, 2016

Study Start

October 1, 2016

Primary Completion

November 15, 2017

Study Completion

April 30, 2018

Last Updated

March 29, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations