Protein Requirements for Active Adolescent Males (IAAO-AM)

Sponsor

University of Toronto (Other)

Overall Status

Completed

CT.gov ID

NCT02859181

Collaborator

Ajinomoto Co., Inc. (Industry)

Enrollment

Location

Arm

18.9

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Dietary Supplement: Amino Acid Intake	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

7 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Evaluation of Protein Requirements in Active Adolescent Males

Actual Study Start Date :

Oct 1, 2016

Actual Primary Completion Date :

Nov 15, 2017

Actual Study Completion Date :

Apr 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active, Adolescent males Subjects will receive different levels of amino acid intakes, varying from 0.2-2.67 g/kg/d	Dietary Supplement: Amino Acid Intake Amino acid intakes will be varied at 0.2-2.67 g/kg/d

Arm

Intervention/Treatment

Experimental: Active, Adolescent males

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

Dietary Supplement: Amino Acid Intake

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

Outcome Measures

Primary Outcome Measures

13CO2 ([13]Carbon Dioxide) Excretion (µmol/kg/h) [4 hours per study day]
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.

Secondary Outcome Measures

[13C]Phenylalanine Oxidation (µmol/kg/h) [4 hours per study day]
Each trial day will assess a different protein intake with 13CO2 excretion defining the level phenylalanine oxidation being used as a secondary marker of protein adequacy. Each trial day will be separated by ~1wk washout with all trial being completed in approximately 3 months.

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 15 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria (Adolescents):

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

Exclusion Criteria (All Subjects):

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Goldring Centre for High Performance Sport	Toronto	Ontario	Canada	M5S2C9

Sponsors and Collaborators

University of Toronto
Ajinomoto Co., Inc.

Investigators

Principal Investigator: Daniel Moore, PhD, University of Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Daniel Moore, Assistant Professor, University of Toronto

ClinicalTrials.gov Identifier:

NCT02859181

Other Study ID Numbers:

IAAO-AM

First Posted:

Aug 8, 2016

Last Update Posted:

Mar 29, 2019

Last Verified:

Mar 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Daniel Moore, Assistant Professor, University of Toronto

Increased Metabolic Requirement

Study Results

No Results Posted as of Mar 29, 2019