Increased Metabolic RequirementNCT02626429
Protein Requirements In Active Female Populations
A study testing Amino acid intake in people with Increased Metabolic Requirement and Healthy, run by University of Toronto.
Trial 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 adults have traditionally been determined utilizing the nitrogen balance technique, which is prone to underestimating protein… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy 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
- 6 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Jun 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, active, young adult females who regularly participate in moderate-vigorous activity 5x per week, for a minimum of 1 hour
- A minimum score of 10 on the Beep Test (a measure of aerobic fitness)
Who cannot join
- Inability to meet health and physical activity guidelines according to the physical activity readiness questionnaire (PAR-Q+)
- Inability to adhere to any of the protocol guidelines (i.e. alcohol, caffeine consumption)
- Regular tobacco use
- Illicit drug use
About this study
Official title: Evaluation of Protein Requirements in Active, Young Adult Females
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 adults 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.
Read more
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 active, young adult females using the IAAO technique in the presence of a variable intensity exercise stimulus.
- 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 0.2-2.6 g/kg/day
| Study group | Role | What they receive |
|---|---|---|
| Active, Young Adult Famale | Experimental | Participants will complete a bout of exercise and then consume a randomly assigned amino acid intake prior to measuring whole body 13CO2 excretion and phenylalanine oxidation. Receives: Dietary Supplement: Amino acid intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
13CO2 (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 posted10 Dec 2015 (estimated)
- Study startMay 2015
- Primary completionJun 2017
- Study completionJun 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.
- More trials run by University of TorontoThe sponsor's other registered studies.
- 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Ajinomoto Co., Inc.
- Responsible party
- Principal investigator, Daniel Moore, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02626429
- Sponsor's protocol ID
- IAAO-YF
- Status last verified
- Dec 2017
- First submitted
- 7 Dec 2015
- Last updated
- 11 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Protein Requirements in Active, Young Adult Females
- ClinicalTrials.gov ID
- NCT02626429
- Acronym / sponsor ID
- IAAO-YF
- Conditions
- Increased Metabolic Requirement, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Ajinomoto Co., Inc.
- Study start
- May 2015 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 10 Dec 2015 (estimated)
- 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.
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 adults 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 active, young adult females using the IAAO technique in the presence of a variable intensity exercise stimulus.
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, Young Adult Famale | Experimental | Dietary Supplement: Amino acid intakeParticipants will complete a bout of exercise and then consume a randomly assigned amino acid intake prior to measuring whole body 13CO2 excretion and phenylalanine oxidation. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy, active, young adult females who regularly participate in moderate-vigorous activity 5x per week, for a minimum of 1 hour
- A minimum score of 10 on the Beep Test (a measure of aerobic fitness)
Key exclusion criteria (4 listed)
- Inability to meet health and physical activity guidelines according to the physical activity readiness questionnaire (PAR-Q+)
- Inability to adhere to any of the protocol guidelines (i.e. alcohol, caffeine consumption)
- Regular tobacco use
- Illicit drug use
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 0.2-2.6 g/kg/day | Dietary supplement | Active, Young Adult Famale |
Primary outcome
13CO2 (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 11 Dec 2017.
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.
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 University of Toronto.
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 2 inclusion and 4 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 11 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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 (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 11 Dec 2017.