Clinical trial NCT04855474: Protein Requirements in Male and Female Endurance Athletes
Official title: Estimating Post-exercise Protein Requirements in Male and Female Endurance Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Increased Metabolic Requirement
Healthy
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2021-04-22
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Eight men and eight women will be provided three different amino acid intakes on three separate occasions (metabolic trials) over 8 hours following a 20km run. All protein intakes have an amino acid composition modelled off of the profile of egg protein.
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Phenylalanine excretion
timeFrame: 8 hours
Secondary outcomes:
measure: Phenylalanine Oxidation
timeFrame: 8 hours
measure: Phenylalanine net balance
timeFrame: 8 hours
Other outcomes:
measure: Urinary 3-methylhistidine
timeFrame: 8 hours
measure: Protein requirement
timeFrame: 8 hours
Locations:
city: Toronto
country: Canada
facility: Goldring Centre for High Performance Sport
state: Ontario
Study officials:
affiliation: University of Toronto
name: Daniel Moore, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: