Increased Metabolic RequirementNCT04855474
Protein Requirements in Male and Female Endurance Athletes
A study testing Amino Acid Intake in people with Increased Metabolic Requirement and Healthy, run by University of Toronto at 1 site in Canada.
Trial summary
Protein is an essential macronutrient for post-exercise recovery through its ability to provide the amino acid building blocks that support increased rates of muscle and whole body protein synthesis. Read more about this study
- Who is it for?
- Ages 18 to 35 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
- 16 participants
- Where
- 1 siteCanada
- Study dates
- 8 Mar 2021to 30 Dec 2022
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy endurance trained runners. Total weekly running distance of greater than 50km/week and perform endurance exercise for more than 5 hours/week.
- Age 18-35 years old
- Eumenorrheic over last 3 months (one cycle no longer than 42 days and no shorter than 20 days).
- Not using hormonal contraceptives (the pill, implants and injections, hormonal intrauterine devices (IUDs), vaginal ring, skin patch).
- Do not have polycystic ovarian syndrome (PCOS) or other conditions effecting ovarian hormone regularity.
- Not pregnant within the past year.
- Must meet the classification of 'superior' aerobic power for their respective age category based on the ACSM criteria; (women age 20-29 years VO2max >50ml/kg/min and women age 30-35 years VO2max >46ml/kg/min) (men age 20-29 years VO2max >56ml/kg/min and men age 30-35 years VO2max >54ml/kg/min).
Who cannot join
- Inability to meet health and physical activity guidelines according to the CSEP 'Get Active' Questionnaire (Appendix G).
- Inability to adhere to study protocol requirements relating to diet and exercise (i.e. alcohol and caffeine consumption, training/exercise prior to beginning a study testing day).
- Regular use of tobacco and/or other recreational drugs/banned substances (i.e. growth hormone, testosterone, marijuana).
- Self-reported intentional or unintentional weight loss (past 6 months) or plan to lose weight (>5-10kg).
- Amenorrhea (self-reported) in the past 3 months.
- Fewer than 6 menstrual cycles per year.
- Answering yes to any questions asked within the COVID-19 screening questionnaire until 14 days of being symptom free and/or having a negative COVID-19 test
Trial locations and contacts
1 site in 1 country.
Canada1 site
Goldring Centre for High Performance Sport
Toronto, Ontario, M5S2C9
About this study
Official title: Estimating Post-exercise Protein Requirements in Male and Female Endurance Athletes
Protein is an essential macronutrient for post-exercise recovery through its ability to provide the amino acid building blocks that support increased rates of muscle and whole body protein synthesis.
Despite the growing understanding of the importance of post-exercise protein in endurance athlete populations, the impact of sex and female menstrual cycle phase on protein metabolism is not fully understood. To date, no studies have examined protein requirements in female endurance trained athletes.
The aim of the proposed study is to utilize the well-established IAAO method to determine protein requirements in endurance trained female and male athletes in a "real-world" and at-home setting.
- 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
Participants will consume hourly (8 hours) isoenergetic, isonitrogenous beverages containing one of the three protein intakes (0.2g/kg/d, 1.2 g/kg/d, 2.0g/kg/d) assigned in a randomized order between the three metabolic trials. Drinks will be enriched with stable isotope [13C]phenylalanine. The use of stable isotope [13C]phenylalanine will allow for the determination of the fate of AA in the body (incorporation into body protein or oxidation) which can be used to determine protein (AA) requirements.
| Study group | Role | What they receive |
|---|---|---|
| Low Protein | Experimental | 0.2 g/kg/day of protein provided as crystalline amino acid made after egg protein. Receives: Dietary Supplement: Amino Acid Intake |
| Moderate Protein | Experimental | 1.2g/kg/day of protein provided as crystalline amino acid made after egg protein. Receives: Dietary Supplement: Amino Acid Intake |
| High Protein | Experimental | 2.0 g/kg/day of protein provided as crystalline amino acid made after egg protein. Receives: Dietary Supplement: Amino Acid Intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phenylalanine excretion
13CO2 production in umol/kg/h
Measured: 8 hours
Secondary outcomes (2)
Phenylalanine Oxidation
[13C]phenylalanine oxidation in umol/kg/h
Measured: 8 hours
Phenylalanine net balance
Difference between phenylalanine rate of appearance and disappearance
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start8 Mar 2021
- Primary completion31 Oct 2021
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Crossover
- Model description
- Eight men and eight women will be provided three different amino acid intakes on three separate occasions (metabolic trials) over 8 hours following a 20km run. All protein intakes have an amino acid composition modelled off of the profile of egg protein.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Moore, University of Toronto
- Investigators
- Daniel Moore, Ph.D, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04855474
- Sponsor's protocol ID
- IAAO-ETFM
- Status last verified
- Jul 2023
- First submitted
- 18 Apr 2021
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data described in the manuscript will be made available upon request pending application and approval.
Publications
Williamson E, Fung HJW, Adams C, West DWD, Moore DR. Protein Requirements Are Increased in Endurance-Trained Athletes but Similar between Females and Males during Postexercise Recovery. Med Sci Sports Exerc. 2023 Oct 1;55(10):1866-1875. doi: 10.1249/MSS.0000000000003219. Epub 2023 May 19.
PubMed 37710376
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimating Post-exercise Protein Requirements in Male and Female Endurance Athletes
- ClinicalTrials.gov ID
- NCT04855474
- Acronym / sponsor ID
- IAAO-ETFM
- Conditions
- Increased Metabolic Requirement, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 22 Apr 2021 (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.
Protein is an essential macronutrient for post-exercise recovery through its ability to provide the amino acid building blocks that support increased rates of muscle and whole body protein synthesis.
Despite the growing understanding of the importance of post-exercise protein in endurance athlete populations, the impact of sex and female menstrual cycle phase on protein metabolism is not fully understood. To date, no studies have examined protein requirements in female endurance trained athletes.
The aim of the proposed study is to utilize the well-established IAAO method to determine protein requirements in endurance trained female and male athletes in a "real-world" and at-home setting.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Eight men and eight women will be provided three different amino acid intakes on three separate occasions (metabolic trials) over 8 hours following a 20km run. All protein intakes have an amino acid composition modelled off of the profile of egg protein.
| Arm | Type | Receives |
|---|---|---|
| Low Protein | Experimental | Dietary Supplement: Amino Acid Intake0.2 g/kg/day of protein provided as crystalline amino acid made after egg protein. |
| Moderate Protein | Experimental | Dietary Supplement: Amino Acid Intake1.2g/kg/day of protein provided as crystalline amino acid made after egg protein. |
| High Protein | Experimental | Dietary Supplement: Amino Acid Intake2.0 g/kg/day of protein provided as crystalline amino acid made after egg protein. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy endurance trained runners. Total weekly running distance of greater than 50km/week and perform endurance exercise for more than 5 hours/week.
- Age 18-35 years old
- Eumenorrheic over last 3 months (one cycle no longer than 42 days and no shorter than 20 days).
- Not using hormonal contraceptives (the pill, implants and injections, hormonal intrauterine devices (IUDs), vaginal ring, skin patch).
- Do not have polycystic ovarian syndrome (PCOS) or other conditions effecting ovarian hormone regularity.
Key exclusion criteria (7 listed)
- Inability to meet health and physical activity guidelines according to the CSEP 'Get Active' Questionnaire (Appendix G).
- Inability to adhere to study protocol requirements relating to diet and exercise (i.e. alcohol and caffeine consumption, training/exercise prior to beginning a study testing day).
- Regular use of tobacco and/or other recreational drugs/banned substances (i.e. growth hormone, testosterone, marijuana).
- Self-reported intentional or unintentional weight loss (past 6 months) or plan to lose weight (>5-10kg).
- Amenorrhea (self-reported) in the past 3 months.
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 IntakeParticipants will consume hourly (8 hours) isoenergetic, isonitrogenous beverages containing one of the three protein intakes (0.2g/kg/d, 1.2 g/kg/d, 2.0g/kg/d) assigned in a randomized order between the three metabolic trials. Drinks will be enriched with stable isotope [13C]phenylalanine. The use of stable isotope [13C]phenylalanine will allow for the determination of the fate of AA in the body (incorporation into body protein or oxidation) which can be used to determine protein (AA) requirements. | Dietary supplement | High Protein, Low Protein, Moderate Protein |
Primary outcome
Phenylalanine excretion
Time frame: 8 hours
13CO2 production in umol/kg/h
2 secondary outcomes
Phenylalanine Oxidation
Time frame: 8 hours
Phenylalanine net balance
Time frame: 8 hours
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 13 Jul 2023.
- Derived from this study: PubMed 37710376Williamson E, Fung HJW, Adams C, West DWD, Moore DR. Protein Requirements Are Increased in Endurance-Trained Athletes but Similar between Females and Males during Postexercise Recovery. Med Sci Sports Exerc. 2023 Oct 1;55(10):1866-1875. doi: 10.1249/MSS.0000000000003219. Epub 2023 May 19.
- Individual participant dataSharing planned: Yes. Data described in the manuscript will be made available upon request pending application and approval.
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.
Daniel Moore, Ph.D principal investigator
University of Toronto
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 University of Toronto 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 7 inclusion and 7 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 13 Jul 2023. 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?
Phenylalanine excretion (time frame: 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04855474, which also lists 1 linked publication.
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 13 Jul 2023.