Protein Requirement of AthletesNCT02621294
Measuring Protein Requirement Using Amino Acid Oxidation in Strength and Endurance Athletes
A study testing Measuring protein requirement in people with Protein Requirement of Athletes, run by University of Western Ontario, Canada at 1 site in Canada.
Trial summary
Our objective is to determine the dietary requirement of protein for strength and endurance exercise trained (more than 4 months training experience) individuals between 18 - 30 years of age using the indicator amino acid oxidation (IAO) method. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Protein Requirement of Athletes
- What is being tested?
- Measuring protein requirement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2015to Dec 2016
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy strength-trained and endurance-trained (more than 3 months training experience, at least 3x week) individuals (18-30 years old).
Who cannot join
- Unhealthy,
- sedentary individuals,
- those who are taking medication,
- those outside the age range, or
- those who have milk allergies
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Exercise Nutrition Research Laboratory
London, Ontario, N6A 5B9
Peter WR Lemon, PhD, 519-661-2111 ext. 88139, plemon@uwo.ca
Peter Lemon, PhD
About this study
Official title: Measuring Protein Requirement Using the Indicator Amino Acid Oxidation Method in Healthy Young Strength and Endurance Exercise Trained Individuals
Our objective is to determine the dietary requirement of protein for strength and endurance exercise trained (more than 4 months training experience) individuals between 18 - 30 years of age using the indicator amino acid oxidation (IAO) method. This study will be the first to determine the required quantity of protein need per day in strength- and endurance trained young adults using the IAO method.
Read the detailed description
The adequacy of the protein dietary requirement for strength (ST) and endurance (ET) exercise trained individuals has been a subject of considerable debate for many years and, at present, there is a discrepancy between those who establish dietary protein requirements for healthy adults and those issuing guidelines for athletes. Despite past nitrogen balance studies suggesting a greater protein requirement in ST and ET athletes, the Institute of Medicine (2005) recommends "no additional dietary protein for healthy adults undertaking resistance or endurance exercise". Current protein and amino acid (AA) requirement estimates for adults are based on nitrogen balance data which are considered to be flawed due to several methodological problems including the use of single linear regression for analyzing nonlinear data and an over/underestimation of nitrogen intake and excretion, respectively. To overcome these problems, the indicator amino acid oxidation technique (IAO) was developed for determination of dietary AA or protein requirements. The IAO method is based on the concept that when dietary protein is inadequate, all AA, including the indicator AA, will be oxidized. With increasing total protein intake, oxidation of the indicator AA will decrease. Once the requirement is met, there is no further change in the oxidation of the indicator AA and the inflection or 'breakpoint' is the estimated requirement. A mixed-effects change-point regression analysis to F13CO2 (label tracer oxidation in 13CO2 breath) in response to graded amounts of protein will be utilized to over come the limitations of linear regression previously used with nitrogen balance. These protein requirement measures using the IAO has not been carried out on ST or ET individuals previously so this will be the first study to do so. The results of this study will help determine the optimal protein requirement in ST and ET athletes which is important not only for athletes but also for older individuals whose loss of muscle mass has been linked to a variety of health concerns.
- Conditions
- Protein Requirement of Athletes
- Being tested
- Measuring protein requirement
- Keywords
- Protein, indicator amino acid oxidation method, athletes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measuring protein requirementOther
a repeated measures design will be used on each athlete receiving eight graded intakes of protein on separate days in the form of AA in random order ranging from 0.2 to 3.5 g/(kg/d). Three baseline samples of breath and urine will be collected at 60, 45 and 30 min before the stable isotope is given orally. During a period of 150 to 270 min. after stable isotope ingestion, 5 breath and urine samples (every 30 min) will be collected to determine an isotopic plateau in breath and urine. The rate of release of 13CO2 from the oxidation of L-[1-13C] phenylalanine (F 13CO2) in breath will be measured and a breakpoint analysis will determine total protein requirement
| Study group | Role | What they receive |
|---|---|---|
| Measuring protein requirement | Experimental | Measuring protein requirement of athletes by feeding different amount of protein in the form of amino acid mixture and measuring their oxidation through expired CO2 Receives: Other: Measuring protein requirement |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of protein requirement as a response of 13C oxidation (µmol . kg-1 . h-1) of 13C-Phenylalanine to varied graded intakes of protein (g/kg/d) in form of amino acid mixture based on egg protein profile
Oxidation of ingested L-[1-13C] phenylalanine (µmol . kg-1 . h-1) to 13CO2 (µmol . kg-1 . h-1) in response to graded intakes of protein will be measure and after determination of a plateau in oxidation curve (using change point regression analysis), break point will be defined as g/kg/d protein requirement.
Measured: within 8 hours of feeding period
Secondary outcomes (2)
Measuring body composition (percent fat and fat free mass) using air displacement plethysmography (BOD POD)
Participants will report fasted in the morning for the measurement of body fat and fat-free mass percent (%) using a BOD POD.
Measured: 10 minutes fasted in the morning
Measuring resting energy expenditure (kcal/d) using an open-circuit indirect calorimetry
Resting energy expenditure (kcal/d) of all participants will be measured using an indirect calorimetry for duration of 40 min. by laying flat on a bed.
Measured: 40 minutes fasted in the morning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Protein Requirement of AthletesStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Western Ontario, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Lemon, University of Western Ontario, Canada
- Investigators
- Peter Lemon, PhD, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02621294
- Sponsor's protocol ID
- 004
- Status last verified
- Nov 2015
- First submitted
- 26 Nov 2015
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bandegan A, Courtney-Martin G, Rafii M, Pencharz PB, Lemon PWR. Indicator amino acid oxidation protein requirement estimate in endurance-trained men 24 h postexercise exceeds both the EAR and current athlete guidelines. Am J Physiol Endocrinol Metab. 2019 May 1;316(5):E741-E748. doi: 10.1152/ajpendo.00174.2018. Epub 2019 Feb 19.
PubMed 30779631Bandegan A, Courtney-Martin G, Rafii M, Pencharz PB, Lemon PW. Indicator Amino Acid-Derived Estimate of Dietary Protein Requirement for Male Bodybuilders on a Nontraining Day Is Several-Fold Greater than the Current Recommended Dietary Allowance. J Nutr. 2017 May;147(5):850-857. doi: 10.3945/jn.116.236331. Epub 2017 Feb 8.
PubMed 28179492
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Protein Requirement Using the Indicator Amino Acid Oxidation Method in Healthy Young Strength and Endurance Exercise Trained Individuals
- ClinicalTrials.gov ID
- NCT02621294
- Acronym / sponsor ID
- 004
- Conditions
- Protein Requirement of Athletes
- Keywords
- Protein, indicator amino acid oxidation method, athletes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of Western Ontario, CanadaUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 3 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.
Our objective is to determine the dietary requirement of protein for strength and endurance exercise trained (more than 4 months training experience) individuals between 18 - 30 years of age using the indicator amino acid oxidation (IAO) method. This study will be the first to determine the required quantity of protein need per day in strength- and endurance trained young adults using the IAO method.
Detailed description
The adequacy of the protein dietary requirement for strength (ST) and endurance (ET) exercise trained individuals has been a subject of considerable debate for many years and, at present, there is a discrepancy between those who establish dietary protein requirements for healthy adults and those issuing guidelines for athletes. Despite past nitrogen balance studies suggesting a greater protein requirement in ST and ET athletes, the Institute of Medicine (2005) recommends "no additional dietary protein for healthy adults undertaking resistance or endurance exercise". Current protein and amino acid (AA) requirement estimates for adults are based on nitrogen balance data which are considered to be flawed due to several methodological problems including the use of single linear regression for analyzing nonlinear data and an over/underestimation of nitrogen intake and excretion, respectively. To overcome these problems, the indicator amino acid oxidation technique (IAO) was developed for determination of dietary AA or protein requirements. The IAO method is based on the concept that when dietary protein is inadequate, all AA, including the indicator AA, will be oxidized. With increasing total protein intake, oxidation of the indicator AA will decrease. Once the requirement is met, there is no further change in the oxidation of the indicator AA and the inflection or 'breakpoint' is the estimated requirement. A mixed-effects change-point regression analysis to F13CO2 (label tracer oxidation in 13CO2 breath) in response to graded amounts of protein will be utilized to over come the limitations of linear regression previously used with nitrogen balance. These protein requirement measures using the IAO has not been carried out on ST or ET individuals previously so this will be the first study to do so. The results of this study will help determine the optimal protein requirement in ST and ET athletes which is important not only for athletes but also for older individuals whose loss of muscle mass has been linked to a variety of health concerns.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Measuring protein requirement | Experimental | Other: Measuring protein requirementMeasuring protein requirement of athletes by feeding different amount of protein in the form of amino acid mixture and measuring their oxidation through expired CO2 |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy strength-trained and endurance-trained (more than 3 months training experience, at least 3x week) individuals (18-30 years old).
Key exclusion criteria (5 listed)
- Unhealthy,
- sedentary individuals,
- those who are taking medication,
- those outside the age range, or
- those who have milk allergies
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 |
|---|---|---|
| Measuring protein requirementa repeated measures design will be used on each athlete receiving eight graded intakes of protein on separate days in the form of AA in random order ranging from 0.2 to 3.5 g/(kg/d). Three baseline samples of breath and urine will be collected at 60, 45 and 30 min before the stable isotope is given orally. During a period of 150 to 270 min. after stable isotope ingestion, 5 breath and urine samples (every 30 min) will be collected to determine an isotopic plateau in breath and urine. The rate of release of 13CO2 from the oxidation of L-[1-13C] phenylalanine (F 13CO2) in breath will be measured and a breakpoint analysis will determine total protein requirement | Other | Measuring protein requirement |
Primary outcome
measurement of protein requirement as a response of 13C oxidation (µmol . kg-1 . h-1) of 13C-Phenylalanine to varied graded intakes of protein (g/kg/d) in form of amino acid mixture based on egg protein profile
Time frame: within 8 hours of feeding period
Oxidation of ingested L-[1-13C] phenylalanine (µmol . kg-1 . h-1) to 13CO2 (µmol . kg-1 . h-1) in response to graded intakes of protein will be measure and after determination of a plateau in oxidation curve (using change point regression analysis), break point will be defined as g/kg/d protein requirement.
2 secondary outcomes
Measuring body composition (percent fat and fat free mass) using air displacement plethysmography (BOD POD)
Time frame: 10 minutes fasted in the morning
Measuring resting energy expenditure (kcal/d) using an open-circuit indirect calorimetry
Time frame: 40 minutes fasted in the morning
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
- Derived from this study: PubMed 30779631Bandegan A, Courtney-Martin G, Rafii M, Pencharz PB, Lemon PWR. Indicator amino acid oxidation protein requirement estimate in endurance-trained men 24 h postexercise exceeds both the EAR and current athlete guidelines. Am J Physiol Endocrinol Metab. 2019 May 1;316(5):E741-E748. doi: 10.1152/ajpendo.00174.2018. Epub 2019 Feb 19.
- Derived from this study: PubMed 28179492Bandegan A, Courtney-Martin G, Rafii M, Pencharz PB, Lemon PW. Indicator Amino Acid-Derived Estimate of Dietary Protein Requirement for Male Bodybuilders on a Nontraining Day Is Several-Fold Greater than the Current Recommended Dietary Allowance. J Nutr. 2017 May;147(5):850-857. doi: 10.3945/jn.116.236331. Epub 2017 Feb 8.
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.
Peter Lemon, PhD principal investigator
Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measuring protein requirement in people with Protein Requirement of Athletes, run by University of Western Ontario, Canada 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 1 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: status not confirmed, as of the sponsor's last update on 3 Dec 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Lemon, PhD (519 661-2111 ext. 88139, plemon@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurement of protein requirement as a response of 13C oxidation (µmol . kg-1 . h-1) of 13C-Phenylalanine to varied graded intakes of protein (g/kg/d) in form of amino acid mixture based on egg protein profile (time frame: within 8 hours of feeding period). 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 NCT02621294, which also lists 2 linked publications.
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 3 Dec 2015.