Exercise TrainingNCT06138951
Exercise Dose-response and Protein Requirements
A study testing Endurance exercise in people with Exercise Training, run by University of Toronto at 1 site in Canada.
Trial summary
Study will investigate the impact of training volume on protein metabolism to estimate the impact on daily protein requirements of endurance athletes. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise Training
- What is being tested?
- Endurance exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteCanada
- Study dates
- 17 Nov 2017to 1 Jan 2019
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, male, endurance-trained participants who regularly run more than 40 km/week or perform endurance exercise for more than 4.5 hours/week
- Participants who have a self-reported 5-km run time of ≤23 min
- Participants who are categorized as at least "very good" based on a study by Shvartz \& Reibold (Aviat Space Environ Med. 1990 Jan;61(1):3-11), in which VO2peak is used as an index. (i.e. the participants whose VO2peak is ≥57 ml/kg/min (18-24 y), ≥54 ml/kg/min (25-29 y), ≥52 ml/kg/min (30-34 y), ≥49 ml/kg/min (35-39 y)
- Ability to complete the 16-km familiarization run on Session 2
- Aged 18-40 years old
Who cannot join
- - Inability to meet health and physical activity guidelines according to the PAR-Q+.
- Female: hormonal fluctuations associated with the menstrual cycle have been reported to alter protein metabolism during exercise and may influence specific amino acid requirements at rest; as such, the present study will test the effect of endurance exercise on protein requirements in males only to ensure a stable hormonal environment and to increase the homogeneity of the physiological response. (NOTE: we plan to test females in a future trial based off of the results obtained herein)
- Inability to adhere to any of the protocol guidelines (i.e. alcohol, caffeine consumption)
- Regular tobacco use
- Illicit drug use (e.g. growth hormone, testosterone, etc.)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Goldring Centre for High Performance Sport at the University of Toronto
Toronto, Ontario, M5S2C9
About this study
Official title: Dose Response Effect of Endurance Exercise on Protein Requirements of Endurance Athletes
Study will investigate the impact of training volume on protein metabolism to estimate the impact on daily protein requirements of endurance athletes.
- Conditions
- Exercise Training
- Being tested
- Endurance exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endurance exerciseOther
On the trial day before commencing the indicator amino acid oxidation metabolic trial, participants will either rest, perform a 10km run on a treadmill, or perform a 20km run on a treadmill.
| Study group | Role | What they receive |
|---|---|---|
| Nonexercised rested day | Placebo comparator | Athlete will not exercise on trial day. Receives: Other: Endurance exercise |
| Recovery from 10KM run | Experimental | Athlete will run 10km on trial day. Receives: Other: Endurance exercise |
| Recovery from 20KM run | Experimental | Athlete will run 20km on trial day. Receives: Other: Endurance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phenylalanine excretion
Excretion of 13CO2 in the breath will be used to estimate the impact of exercise on daily protein requirements. This outcome will include the enrichment of 13CO2 in exhaled breath after the ingestion of [13C]phenylalanine tracer and the production of CO2 determined by indirect calorimetry at rest or after exercise.
Measured: 8 hours
Secondary outcomes (2)
Phenylalanine flux
The enrichment of [13C]phenylalanine in the urine will be used to estimate the flux of phenylalanine in the body at rest or after exercise.
Measured: 8 hours
Phenylalanine oxidation
The oxidation of [13C]phenylalanine will be determined by correcting phenylalanine excretion by phenylalanine flux.
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 posted18 Nov 2023
- Study start17 Nov 2017
- Primary completion15 Aug 2018
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise TrainingStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 7 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06138951
- Sponsor's protocol ID
- DRE
- Status last verified
- Jan 2024
- First submitted
- 9 Nov 2023
- Last updated
- 5 Jan 2024
- 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 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Response Effect of Endurance Exercise on Protein Requirements of Endurance Athletes
- ClinicalTrials.gov ID
- NCT06138951
- Acronym / sponsor ID
- DRE
- Conditions
- Exercise Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 17 Nov 2017 (actual)
- Primary completion
- 15 Aug 2018 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 18 Nov 2023 (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.
Study will investigate the impact of training volume on protein metabolism to estimate the impact on daily protein requirements of endurance athletes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nonexercised rested day | Placebo comparator | Other: Endurance exerciseAthlete will not exercise on trial day. |
| Recovery from 10KM run | Experimental | Other: Endurance exerciseAthlete will run 10km on trial day. |
| Recovery from 20KM run | Experimental | Other: Endurance exerciseAthlete will run 20km on trial day. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy, male, endurance-trained participants who regularly run more than 40 km/week or perform endurance exercise for more than 4.5 hours/week
- Participants who have a self-reported 5-km run time of ≤23 min
- Participants who are categorized as at least "very good" based on a study by Shvartz \& Reibold (Aviat Space Environ Med. 1990 Jan;61(1):3-11), in which VO2peak is used as an index. (i.e. the participants whose VO2peak is ≥57 ml/kg/min (18-24 y), ≥54 ml/kg/min (25-29 y), ≥52 ml/kg/min (30-34 y), ≥49 ml/kg/min (35-39 y)
- Ability to complete the 16-km familiarization run on Session 2
- Aged 18-40 years old
Key exclusion criteria (5 listed)
- - Inability to meet health and physical activity guidelines according to the PAR-Q+.
- Female: hormonal fluctuations associated with the menstrual cycle have been reported to alter protein metabolism during exercise and may influence specific amino acid requirements at rest; as such, the present study will test the effect of endurance exercise on protein requirements in males only to ensure a stable hormonal environment and to increase the homogeneity of the physiological response. (NOTE: we plan to test females in a future trial based off of the results obtained herein)
- Inability to adhere to any of the protocol guidelines (i.e. alcohol, caffeine consumption)
- Regular tobacco use
- Illicit drug use (e.g. growth hormone, testosterone, etc.)
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 |
|---|---|---|
| Endurance exerciseOn the trial day before commencing the indicator amino acid oxidation metabolic trial, participants will either rest, perform a 10km run on a treadmill, or perform a 20km run on a treadmill. | Other | Nonexercised rested day, Recovery from 10KM run, Recovery from 20KM run |
Primary outcome
Phenylalanine excretion
Time frame: 8 hours
Excretion of 13CO2 in the breath will be used to estimate the impact of exercise on daily protein requirements. This outcome will include the enrichment of 13CO2 in exhaled breath after the ingestion of [13C]phenylalanine tracer and the production of CO2 determined by indirect calorimetry at rest or after exercise.
2 secondary outcomes
Phenylalanine flux
Time frame: 8 hours
Phenylalanine oxidation
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 5 Jan 2024.
- Individual participant dataSharing planned: No
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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 Endurance exercise in people with Exercise Training, 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 5 inclusion and 5 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 5 Jan 2024. 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. Some participants in this study may receive a placebo. 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?
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 5 Jan 2024.