- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02621294
Measuring Protein Requirement Using Amino Acid Oxidation in Strength and Endurance Athletes
November 30, 2015 updated by: Peter Lemon, University of Western Ontario, Canada
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6A 5B9
- Recruiting
- Exercise Nutrition Research Laboratory
-
Contact:
- Peter WR Lemon, PhD
- Phone Number: 88139 519-661-2111
- Email: plemon@uwo.ca
-
Principal Investigator:
- Peter Lemon, PhD
-
Sub-Investigator:
- Arash Bandegan, MSc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Healthy strength-trained and endurance-trained (more than 3 months training experience, at least 3x week) individuals (18-30 years old).
Exclusion Criteria:
- Unhealthy,
- sedentary individuals,
- those who are taking medication,
- those outside the age range, or
- those who have milk allergies
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Measuring protein requirement
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
within 8 hours of feeding period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measuring body composition (percent fat and fat free mass) using air displacement plethysmography (BOD POD)
Time Frame: 10 minutes fasted in the morning
|
Participants will report fasted in the morning for the measurement of body fat and fat-free mass percent (%) using a BOD POD.
|
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
|
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.
|
40 minutes fasted in the morning
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Bandegan 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2015
Primary Completion (Anticipated)
December 1, 2016
Study Completion (Anticipated)
December 1, 2016
Study Registration Dates
First Submitted
November 26, 2015
First Submitted That Met QC Criteria
November 30, 2015
First Posted (Estimate)
December 3, 2015
Study Record Updates
Last Update Posted (Estimate)
December 3, 2015
Last Update Submitted That Met QC Criteria
November 30, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- 004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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