- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03163043
Protein Requirements for Active Children (IAAO-C)
Evaluation of Protein Requirements in Active Children
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
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Toronto, Ontario, Canada, M5S 2C9
- Goldring Centre for High Performance Sport
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Collaborators
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 (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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