Protein Requirements in Male and Female Endurance Athletes

July 11, 2023 updated by: Daniel Moore, University of Toronto

Estimating Post-exercise Protein Requirements in Male and Female Endurance Athletes

Protein is an essential macronutrient for post-exercise recovery through its ability to provide the amino acid building blocks that support increased rates of muscle and whole body protein synthesis.

Despite the growing understanding of the importance of post-exercise protein in endurance athlete populations, the impact of sex and female menstrual cycle phase on protein metabolism is not fully understood. To date, no studies have examined protein requirements in female endurance trained athletes.

The aim of the proposed study is to utilize the well-established IAAO method to determine protein requirements in endurance trained female and male athletes in a "real-world" and at-home setting.

Study Overview

Status

Status

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

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

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 (Actual)

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 Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5S2C9
        • Goldring Centre for High Performance Sport

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 35 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy endurance trained runners. Total weekly running distance of greater than 50km/week and perform endurance exercise for more than 5 hours/week.
  • Age 18-35 years old
  • Eumenorrheic over last 3 months (one cycle no longer than 42 days and no shorter than 20 days).
  • Not using hormonal contraceptives (the pill, implants and injections, hormonal intrauterine devices (IUDs), vaginal ring, skin patch).
  • Do not have polycystic ovarian syndrome (PCOS) or other conditions effecting ovarian hormone regularity.
  • Not pregnant within the past year.
  • Must meet the classification of 'superior' aerobic power for their respective age category based on the ACSM criteria; (women age 20-29 years VO2max >50ml/kg/min and women age 30-35 years VO2max >46ml/kg/min) (men age 20-29 years VO2max >56ml/kg/min and men age 30-35 years VO2max >54ml/kg/min).

Exclusion Criteria:

  • Inability to meet health and physical activity guidelines according to the CSEP 'Get Active' Questionnaire (Appendix G).
  • Inability to adhere to study protocol requirements relating to diet and exercise (i.e. alcohol and caffeine consumption, training/exercise prior to beginning a study testing day).
  • Regular use of tobacco and/or other recreational drugs/banned substances (i.e. growth hormone, testosterone, marijuana).
  • Self-reported intentional or unintentional weight loss (past 6 months) or plan to lose weight (>5-10kg).
  • Amenorrhea (self-reported) in the past 3 months.
  • Fewer than 6 menstrual cycles per year.
  • Answering yes to any questions asked within the COVID-19 screening questionnaire until 14 days of being symptom free and/or having a negative COVID-19 test

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

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover 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: Low Protein
0.2 g/kg/day of protein provided as crystalline amino acid made after egg protein.
Dietary supplement: Amino Acid Intake
Participants will consume hourly (8 hours) isoenergetic, isonitrogenous beverages containing one of the three protein intakes (0.2g/kg/d, 1.2 g/kg/d, 2.0g/kg/d) assigned in a randomized order between the three metabolic trials. Drinks will be enriched with stable isotope [13C]phenylalanine. The use of stable isotope [13C]phenylalanine will allow for the determination of the fate of AA in the body (incorporation into body protein or oxidation) which can be used to determine protein (AA) requirements.
Experimental: Moderate Protein
1.2g/kg/day of protein provided as crystalline amino acid made after egg protein.
Dietary supplement: Amino Acid Intake
Participants will consume hourly (8 hours) isoenergetic, isonitrogenous beverages containing one of the three protein intakes (0.2g/kg/d, 1.2 g/kg/d, 2.0g/kg/d) assigned in a randomized order between the three metabolic trials. Drinks will be enriched with stable isotope [13C]phenylalanine. The use of stable isotope [13C]phenylalanine will allow for the determination of the fate of AA in the body (incorporation into body protein or oxidation) which can be used to determine protein (AA) requirements.
Experimental: High Protein
2.0 g/kg/day of protein provided as crystalline amino acid made after egg protein.
Dietary supplement: Amino Acid Intake
Participants will consume hourly (8 hours) isoenergetic, isonitrogenous beverages containing one of the three protein intakes (0.2g/kg/d, 1.2 g/kg/d, 2.0g/kg/d) assigned in a randomized order between the three metabolic trials. Drinks will be enriched with stable isotope [13C]phenylalanine. The use of stable isotope [13C]phenylalanine will allow for the determination of the fate of AA in the body (incorporation into body protein or oxidation) which can be used to determine protein (AA) requirements.

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
Phenylalanine excretion
Time Frame: 8 hours
13CO2 production in umol/kg/h
8 hours

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
Phenylalanine Oxidation
Time Frame: 8 hours
[13C]phenylalanine oxidation in umol/kg/h
8 hours
Phenylalanine net balance
Time Frame: 8 hours
Difference between phenylalanine rate of appearance and disappearance
8 hours

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Urinary 3-methylhistidine
Time Frame: 8 hours
Concentration of urine 3-methylhistidine
8 hours
Protein requirement
Time Frame: 8 hours
Estimated breakpoint of phenylalanine excretion, phenylalanine oxidation, and phenylalanine net balance
8 hours

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 Toronto

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Daniel Moore, Ph.D, University of Toronto

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 (Actual)

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.
March 8, 2021

Primary Completion (Actual)

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.
October 31, 2021

Study Completion (Actual)

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 30, 2022

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).
April 18, 2021

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.
April 18, 2021

First Posted (Actual)

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.
April 22, 2021

Study Record Updates

Last Update Posted (Actual)

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.
July 13, 2023

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.
July 11, 2023

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.
July 1, 2023

More Information

Terms related to this study

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.
  • IAAO-ETFM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data described in the manuscript will be made available upon request pending application and approval.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Healthy

Clinical Trials on Amino Acid Intake

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings