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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

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  • Name: Arash Bandegan, MSc
  • Phone Number: 5196140266
  • Email: abandega@uwo.ca

Study Locations

  • Canada
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Other: Measuring protein requirement
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Western Ontario, Canada

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 26, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 3, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 3, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 004

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