HealthyNCT02801344
The Impact of Protein Intake on Protein Metabolism During Intensified Training
A study testing Normal, Moderate and High in people with Healthy, run by University of Toronto at 1 site in Canada.
Trial summary
Protein requirements in individuals who participate in endurance-based exercise training have been suggested to be greater than the current recommended dietary allowance (RDA). Our recent study using the minimally invasive indicator amino acid oxidation (IAAO) technique have suggested that protein requirements in… Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Normal, Moderate and High
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- May 2016to Feb 2018
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, male, endurance-trained participants who have run regularly more than 45 km or 4.5 hours/week
- Participants who are categorized at least "very good" based on a study by Shvartz \& Reibold [40], in which peak rate of oxygen consumption(VO2 Peak) 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), ≥47 ml/kg/min (40-44 y), ≥44 ml/kg/min (45-50 y) according to his age,
- Participants who can cover 10 km in less than 60 min after the VO2peak test and 5 km Time trial on session 2.
- Participants will be 18-50 years old.
- Participants are willing to abide by the compliance rules of this study
Who cannot join
- Inability to meet health and physical activity guidelines according to the The Physical Activity Readiness Questionnaire for everyone.
- Female
- Inability to adhere to any of the compliance rules judged by principal investigator or medical doctor
- 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
Toronto, Ontario, M5S 2C9
About this study
Official title: The Impact of Protein Intake on Amino Acid and Protein Metabolism, and Performance During Intensified Training
Protein requirements in individuals who participate in endurance-based exercise training have been suggested to be greater than the current recommended dietary allowance (RDA).
Our recent study using the minimally invasive indicator amino acid oxidation (IAAO) technique have suggested that protein requirements in young men are at least 30% higher than the recommended protein intake.
The present study will investigate the impact of protein sufficiency on protein metabolism and performance during intensified training periods as a means to further our understanding of the nutritional requirements for the endurance athlete.
- Conditions
- Healthy
- Being tested
- Normal, Moderate, High, Controlled-diet
- Keywords
- exercise, performance, recovery, muscle, protein
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NormalDietary supplement
test drink which contains low amount of amino acids (0.14 g/kg/day)
ModerateDietary supplement
test drink which contains moderate amount of amino acids (0.40 g/kg/day)
HighDietary supplement
test drink which contains high amount of amino acids (1.03 g/kg/day)
Controlled-dietOther
the diet containing 0.8 g protein /kg/day
| Study group | Role | What they receive |
|---|---|---|
| Normal protein intake | Experimental | participants will receive the controlled-diet containing 0.8 g protein /kg/day and the test drink containing 0.14 g protein/kg/d. Receives: Dietary Supplement: Normal; Other: Controlled-diet |
| Moderate protein intake | Experimental | participants will receive the controlled-diet containing 1.20 g protein /kg/day and the test drink containing 0.40 g protein/kg/d. Receives: Dietary Supplement: Moderate; Other: Controlled-diet |
| High protein intake | Experimental | participants will receive the controlled-diet containing 1.83 g protein /kg/day and the test drink containing 1.03 g protein/kg/d. Receives: Dietary Supplement: High; Other: Controlled-diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 24h whole body protein balance
Protein balance (mg/kg/d; protein synthesis - protein breakdown) will be measured using [15N]Glycine method on day 1 and day 4 to determine the change over the intensified training period to compare between protein levels
Measured: Difference between day 1 and day 4 whole body protein balance
Secondary outcomes (3)
Change from baseline physical performance (5 km time trial) 5days after the beginning of training
Before and after 4 days of intensified training period, Duration (seconds) for completing 5-km running on treadmill will be measured.
Measured: 5days after the beginning of training
change from baseline Physical performance (muscle strength) 5days after the beginning of training
Maximal strength will be assessed by a maximal isometric voluntary contraction (MVC), which will be tested for the knee-extensors using a custom-made knee-extension apparatus after 4 days intensified training.
Measured: 5days after the beginning of training
change from baseline Physical Performance (muscle power) 5days after the beginning of training
Peak lower body power will be measured by force platform after 4days-intensified training.
Measured: 5days after the beginning of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionSep 2017
- Study completionFeb 2018
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 HealthyStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 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
- Investigators
- Daniel Moore, Ph.D., Principal investigator, Faculty of Kinesiology and Physical Education, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02801344
- Sponsor's protocol ID
- PFE
- Status last verified
- Mar 2019
- First submitted
- 25 May 2016
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Williamson E, Kato H, Volterman KA, Suzuki K, Moore DR. Greater plasma essential amino acids and lower 3-methylhistidine with higher protein intake during endurance training: a randomised control trial. Amino Acids. 2023 Oct;55(10):1285-1291. doi: 10.1007/s00726-022-03210-z. Epub 2022 Dec 7.
PubMed 36477889
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
- The Impact of Protein Intake on Amino Acid and Protein Metabolism, and Performance During Intensified Training
- ClinicalTrials.gov ID
- NCT02801344
- Acronym / sponsor ID
- PFE
- Conditions
- Healthy
- Keywords
- exercise, performance, recovery, muscle, protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Ajinomoto Co., Inc.
- Study start
- May 2016
- Primary completion
- Sep 2017 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 15 Jun 2016 (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 individuals who participate in endurance-based exercise training have been suggested to be greater than the current recommended dietary allowance (RDA).
Our recent study using the minimally invasive indicator amino acid oxidation (IAAO) technique have suggested that protein requirements in young men are at least 30% higher than the recommended protein intake.
The present study will investigate the impact of protein sufficiency on protein metabolism and performance during intensified training periods as a means to further our understanding of the nutritional requirements for the endurance athlete.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal protein intake | Experimental | Dietary Supplement: Normal, Other: Controlled-dietparticipants will receive the controlled-diet containing 0.8 g protein /kg/day and the test drink containing 0.14 g protein/kg/d. |
| Moderate protein intake | Experimental | Dietary Supplement: Moderate, Other: Controlled-dietparticipants will receive the controlled-diet containing 1.20 g protein /kg/day and the test drink containing 0.40 g protein/kg/d. |
| High protein intake | Experimental | Dietary Supplement: High, Other: Controlled-dietparticipants will receive the controlled-diet containing 1.83 g protein /kg/day and the test drink containing 1.03 g protein/kg/d. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy, male, endurance-trained participants who have run regularly more than 45 km or 4.5 hours/week
- Participants who are categorized at least "very good" based on a study by Shvartz \& Reibold [40], in which peak rate of oxygen consumption(VO2 Peak) 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), ≥47 ml/kg/min (40-44 y), ≥44 ml/kg/min (45-50 y) according to his age,
- Participants who can cover 10 km in less than 60 min after the VO2peak test and 5 km Time trial on session 2.
- Participants will be 18-50 years old.
- Participants are willing to abide by the compliance rules of this study
Key exclusion criteria (5 listed)
- Inability to meet health and physical activity guidelines according to the The Physical Activity Readiness Questionnaire for everyone.
- Female
- Inability to adhere to any of the compliance rules judged by principal investigator or medical doctor
- 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 |
|---|---|---|
| Normaltest drink which contains low amount of amino acids (0.14 g/kg/day) | Dietary supplement | Normal protein intake |
| Moderatetest drink which contains moderate amount of amino acids (0.40 g/kg/day) | Dietary supplement | Moderate protein intake |
| Hightest drink which contains high amount of amino acids (1.03 g/kg/day) | Dietary supplement | High protein intake |
| Controlled-dietthe diet containing 0.8 g protein /kg/day | Other | High protein intake, Moderate protein intake, Normal protein intake |
Primary outcome
Change in 24h whole body protein balance
Time frame: Difference between day 1 and day 4 whole body protein balance
Protein balance (mg/kg/d; protein synthesis - protein breakdown) will be measured using [15N]Glycine method on day 1 and day 4 to determine the change over the intensified training period to compare between protein levels
3 secondary outcomes
Change from baseline physical performance (5 km time trial) 5days after the beginning of training
Time frame: 5days after the beginning of training
change from baseline Physical performance (muscle strength) 5days after the beginning of training
Time frame: 5days after the beginning of training
change from baseline Physical Performance (muscle power) 5days after the beginning of training
Time frame: 5days after the beginning of training
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.
- Derived from this study: PubMed 36477889Williamson E, Kato H, Volterman KA, Suzuki K, Moore DR. Greater plasma essential amino acids and lower 3-methylhistidine with higher protein intake during endurance training: a randomised control trial. Amino Acids. 2023 Oct;55(10):1285-1291. doi: 10.1007/s00726-022-03210-z. Epub 2022 Dec 7.
- 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.
Daniel Moore, Ph.D. principal investigator
Faculty of Kinesiology and Physical Education, 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 Normal, Moderate and High in people with 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 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 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?
Change in 24h whole body protein balance (time frame: Difference between day 1 and day 4 whole body protein balance). 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 NCT02801344, 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 29 Mar 2019; AzTrials last refreshed its copy on 8 Nov 2026.