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Clinical Trials/NCT07258576
NCT07258576RecruitingNot Applicable

The Effect of Menstrual Cycle Phase and Oral Contraceptive Use on Muscle Protein Metabolism Post-Resistance Training

University of Toronto2 sites in 1 country20 target enrollmentStarted: July 20, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
20
Locations
2
Primary Endpoint
Muscle Protein Synthesis (MPS)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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)

Outcomes

Primary Outcomes

Muscle Protein Synthesis (MPS)

Time Frame: 8 hours

Muscle protein synthesis (MPS) will be assessed during an 8-hour post-exercise and feeding period using a stable isotope tracer, L-\[ring-D5\]phenylalanine (\[D5\]Phe). The incorporation of the \[D5\]Phe tracer into myofibrillar muscle proteins, collected from muscle biopsies (pre-exercise and post-8h feeding), will be analyzed using liquid chromatography-tandem mass spectrometry (LC-MS/MS) to determine the fractional synthesis rate (FSR) of muscle proteins. This will help us understand how menstrual cycle phases and oral contraceptive use influence MPS, providing insight into optimizing protein intake and training adaptations in female athletes.

Secondary Outcomes

  • Whole Body Protein Synthesis (WBPS)(4 hours)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Daniel Moore

Associate Professor

University of Toronto

Study Sites (2)

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