- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02859181
Protein Requirements for Active Adolescent Males (IAAO-AM)
Evaluation of Protein Requirements in Active Adolescent Males
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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5S2C9
- Goldring Centre for High Performance Sport
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
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, Adolescent males
Subjects 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 |
Measure Description |
Time Frame |
---|---|---|
13CO2 ([13]Carbon Dioxide) Excretion (µmol/kg/h)
Time Frame: 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.
|
4 hours per study day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
[13C]Phenylalanine Oxidation (µmol/kg/h)
Time Frame: 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.
|
4 hours per study day
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Daniel Moore, PhD, University of Toronto
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IAAO-AM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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