Clinical trial NCT06124274: Oral Contraceptive vs Menstrual Cycle Ex Vivo Model
Official title: The Effect of Menstrual Phase and Oral Contraceptives on Muscle Protein Metabolism
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Contraceptives, Oral
Sex Hormone
Keywords: Oral Contraceptive Use
Menstrual Cycle Phases
Protein Metabolism
Ex Vivo Model
Breath Test
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2023-11-09
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study uses a 4-way counterbalanced crossover design. A total 10 young women (Ages: 18-35 years old; 5 per OC and non-OC group) will be recruited and randomized to begin in either the mid-follicular (7-11 days after the onset of menses) or mid-luteal phase (5-9 days after ovulation) if part of non-OC group; and active pill (10-20 days within starting their new pill cycle) or withdrawal phase (at least 48hrs after their last pill) if part of the OC group. Participants of each group will take part in two metabolic trials, one in each phase of their menstrual cycle or pill cycle.
Primary purpose: OTHER

Brief summary: Despite comprising half the population, females are often left out of muscle research due to the impact of changing hormones during the menstrual cycle and when using oral contraceptives. This makes it hard to perform costly and invasive studies involving tracers to study muscle protein metabolism. Consequently, we lack a clear understanding of how these hormonal changes affect muscle growth.

There is a need for less invasive methods to study how sex hormones and oral contraceptives influence muscle protein metabolism. Ex vivo models, where serum from participants is applied to mouse muscle cell cultures, mimic the conditions of human muscle cells and can provide initial insights.

Detailed description: The aim of the study is to develop a non-invasive model using serum from both oral contraceptive users and non-users at various stages of their cycles, to understand if different cycle or pill stages affect how muscles process proteins.

Eligibility criteria: Inclusion Criteria:

* BMI between 18.5-29.9 kg/m2 (I.e., non-obese).
* For OC users: on monophasic OCs for \> 3 months prior to study enrollment
* For non-OC users: regular menstrual cycles length (25-35 days) for at least 3 months prior to study and at least 6 months off of OCs.

Exclusion Criteria:

* Chronic disease diagnosis (cardiovascular, thyroid, diabetes)
* Current or recent remission of cancer
* Regular use of NSAID (except low-dose aspirin), anticoagulants
* Use of prescription drugs that would impact metabolism, e.g. Statins, Lithium, Attention-Deficit/Hyperactivity Disorder (ADHD) medication.
* Insertion of intrauterine device (IUD) - exception: copper
* Use of ergogenic aids such as creatine
* Regular Tabacco use
* Use of illicit drugs (growth hormones, testosterone)
* For non-OC users: Use of oral contraceptives for \> 6 months prior to study enrollment - to ensure return to regular menstrual cycle.

Primary outcomes:
measure: Protein Synthesis (Murine Cell-Based Experiments, ex-vivo experiments)
timeFrame: 60 minutes
Secondary outcomes:
measure: Whole-body protein synthesis
timeFrame: 6 hours
measure: Urinary Measures (Muscle Protein Breakdown)
timeFrame: 6 hours
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Goldring Centre for High Performance Sport at the University of Toronto
state: Ontario
Study officials:
affiliation: University of Toronto
name: Ines Kortebi, PhD Student
role: STUDY_DIRECTOR
affiliation: University of Toronto
name: Cassidy Tinline-Goodfellow, PhD (C)
role: STUDY_DIRECTOR
affiliation: University of Toronto
name: Jonathan Aguilera, PhD Student
role: STUDY_DIRECTOR
References: