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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04855474
Other study ID # IAAO-ETFM
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 8, 2021
Est. completion date December 30, 2022

Study information

Verified date July 2023
Source University of Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date December 30, 2022
Est. primary completion date October 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Canada Goldring Centre for High Performance Sport Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Urinary 3-methylhistidine Concentration of urine 3-methylhistidine 8 hours
Other Protein requirement Estimated breakpoint of phenylalanine excretion, phenylalanine oxidation, and phenylalanine net balance 8 hours
Primary Phenylalanine excretion 13CO2 production in umol/kg/h 8 hours
Secondary Phenylalanine Oxidation [13C]phenylalanine oxidation in umol/kg/h 8 hours
Secondary Phenylalanine net balance Difference between phenylalanine rate of appearance and disappearance 8 hours
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