Increased Metabolic RequirementIAAO-CNCT03163043
Protein Requirements for Active Children
A study testing Amino Acid Intake in people with Increased Metabolic Requirement and Healthy, run by Daniel Moore at 1 site in Canada.
Trial summary
Nutritional requirements for dietary amino acids in children have traditionally been determined utilizing the nitrogen balance technique, which is prone to underestimating protein requirements. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Increased Metabolic Requirement, Healthy
- What is being tested?
- Amino Acid Intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- 22 Oct 2016to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Goldring Centre For High Performance Sport
Toronto, Ontario, M5S 2C9
About this study
Official title: 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.
Read the 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.
- Conditions
- Increased Metabolic Requirement, Healthy
- Being tested
- Amino Acid Intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amino Acid IntakeDietary supplement
Amino acid intakes will be varied at 0.2-2.67 g/kg/d
| Study group | Role | What they receive |
|---|---|---|
| Active, Male and Female Children | Experimental | Participants will receive different levels of amino acid intakes, varying from 0.2-2.67 g/kg/d Receives: Dietary Supplement: Amino Acid Intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
13CO2 ([13]Carbon Dioxide) Excretion (µmol/kg/h)
Measured: 4 hours/study day
Secondary outcomes (1)
[13C]Phenylalanine Oxidation (µmol/kg/h)
Measured: 4 hours/study day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start22 Oct 2016
- Primary completion31 Oct 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Increased Metabolic RequirementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniel Moore
- Sponsor type
- University, hospital or other
- Collaborators
- Ajinomoto Co., Inc.
- Responsible party
- Sponsor-investigator, Daniel Moore, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03163043
- Sponsor's protocol ID
- IAAO-C
- Acronym
- IAAO-C
- Status last verified
- Mar 2019
- First submitted
- 19 May 2017
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Protein Requirements in Active Children
- ClinicalTrials.gov ID
- NCT03163043
- Acronym / sponsor ID
- IAAO-C / IAAO-C
- Conditions
- Increased Metabolic Requirement, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Daniel MooreUniversity, hospital or other
- Collaborators
- Ajinomoto Co., Inc.
- Study start
- 22 Oct 2016 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 22 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active, Male and Female Children | Experimental | Dietary Supplement: Amino Acid IntakeParticipants will receive different levels of amino acid intakes, varying from 0.2-2.67 g/kg/d |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amino Acid IntakeAmino acid intakes will be varied at 0.2-2.67 g/kg/d | Dietary supplement | Active, Male and Female Children |
Primary outcome
13CO2 ([13]Carbon Dioxide) Excretion (µmol/kg/h)
Time frame: 4 hours/study day
1 secondary outcome
[13C]Phenylalanine Oxidation (µmol/kg/h)
Time frame: 4 hours/study day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amino Acid Intake in people with Increased Metabolic Requirement and Healthy, run by Daniel Moore at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
13CO2 ([13]Carbon Dioxide) Excretion (µmol/kg/h) (time frame: 4 hours/study day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2019.