- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04855474
Protein Requirements in Male and Female Endurance Athletes
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5S2C9
- Goldring Centre for High Performance Sport
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Low Protein
0.2 g/kg/day of protein provided as crystalline amino acid made after egg protein.
|
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.
|
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.
|
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
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Phenylalanine excretion
Time Frame: 8 hours
|
13CO2 production in umol/kg/h
|
8 hours
|
Secondary Outcome Measures
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
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
Sponsor
Investigators
- Principal Investigator: Daniel Moore, Ph.D, University of Toronto
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IAAO-ETFM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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