Recruiting

Protein Turnover

Sponsor:

University of Toronto

Code:

NCT07258576

Conditions

Female Sex Hormones

Menstrual Cycle

Oral Contraceptives

Protein Metabolism

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

Protein Beverage

Stable Isotope Tracer [D5]phenylalanine

Stable Isotope Tracer [13C]phenylalanine

Study Details

Brief summary:

The muscles of the body are constantly breaking down old proteins and building new ones. These two processes, protein breakdown and protein synthesis, together are known as protein turnover. Protein turnover is essential for maintaining healthy muscle.

Despite its importance, females have historically been underrepresented in protein metabolism research. A long-standing assumption has been that fluctuations in female sex hormones such as estrogen and progesterone, whether across the natural menstrual cycle or in individuals using oral contraceptives (OCs), make metabolism and training responses too variable to study. Because of this, many researchers have excluded female participants for logistical reasons.

Resistance exercise, such as weightlifting, is the most effective way to increase muscle size and strength. Each resistance-training session triggers muscle protein synthesis (MPS), the process by which new muscle proteins are built. Consuming dietary protein or individual amino acids further increases the rate at which new proteins are formed. Over time, higher rates of protein synthesis support muscle growth and the maintenance of other lean tissues in the body.

The purpose of this study is to examine how menstrual cycle phases and OC use influence the synthesis of proteins in both muscle tissue and the rest of the body. Improving scientific understanding in this area will support more effective, evidence-based training and nutrition recommendations for females.

Conditions

Female Sex Hormones

Menstrual Cycle

Oral Contraceptives

Protein Metabolism

Study ID

NCT07258576

Start date

Jul 20, 2025

Status verified date

Nov, 2025

Completion date

Sep 1, 2026

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Age: 18-40 years
  • BMI between 18.5-29.9 kg/m2 (non-obese)
  • Recreationally active (resistance train minimum twice a week)
  • Using monophasic or triphasic oral contraceptives for >1 year (for oral contraceptive users)
  • Have regular menstrual cycles (21-35 days) for the past 3 months and discontinued any hormonal contraceptive use for at least 6 months (non-oral contraceptive users)
  • Must meet a progesterone sufficiency test (non-oral contraceptive users)

Exclusion Criteria:

  • Mid-luteal progesterone levels <16umol
  • Chronic disease diagnosis (cardiovascular, thyroid, diabetes)
  • Current or recent remission of cancer
  • Regular use of non-steroidal anti-inflammatory drugs (NSAIDs; except low-dose aspirin), anticoagulants
  • Use of prescription drugs that would impact muscle protein synthesis, e.g. Statins, Lithium, ADHD medication.
  • Insertion of intrauterine device (IUD) - exception: copper
  • Use of emergency contraception in the last 3 months (e.g. Plan B)
  • Severe food allergies (e.g. soy, nuts)
  • Smoking, use of performance enhancing drugs (growth hormones, testosterone)

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: Mid-Luteal Phase

5-9 days post-ovulation

other: Early Follicular Phase

Days 2-6 post-menses onset

other: Active Pill Phase

Days 10-20 of active pill

other: Placebo Pill Phase

At least 48h after last active pill is taken

Interventions

Protein Beverage

Participants will consume 16 half-hourly (8 hours) isoenergetic, isonitrogenous beverages containing 1.2 g/kg/d protein.

Stable Isotope Tracer [D5]phenylalanine

Protein beverages will be enriched with the stable isotope \[D5\]phenylalanine. The use of \[D5\]phenylalanine will allow for determination of muscle protein synthesis.

Stable Isotope Tracer [13C]phenylalanine

Protein beverages will be enriched with the stable isotope tracer \[13C\]phenylalanine. The use of \[13C\]phenylalanine will allow for the determination of the fate of amino acids in the body (incorporation into body protein or oxidation) which can be used to determine protein requirements.

Primary outcome measure

  • Muscle Protein Synthesis (MPS) [ Time Frame: 8 hours ]

Central Contacts and Locations

Central contacts

Ines Kortebi, PhD Candidate

ines.kortebi@mail.utoronto.ca

Locations

Goldring Center for High Performance Sport

Recruiting

Toronto, Ontario, Canada, M5S 2C9

Contacts

Ines Kortebi, PhD Candidate

6479392755ines.kortebi@mail.utoronto.ca

More Information

Sponsor

University of Toronto

Last update posted

Dec 2, 2025

Last verified

Nov, 2025

Keywords

  • Protein Metabolism
  • Female Sex Hormones
  • Menstrual Cycle
  • Oral Contraceptives
  • Resistance Exercise
  • Weightlifting
  • Indicator Amino Acid Oxidation
  • Stable Isotope Tracer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Toronto on 2025-12-02.