Comparing the effects of oral contraceptives and menstrual cycles on muscle protein metabolism
The Effect of Menstrual Phase and Oral Contraceptives on Muscle Protein Metabolism
This study is testing how oral contraceptives and different stages of the menstrual cycle affect muscle growth in women by looking at how their hormones influence muscle cells.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | Female |
| Sponsor | University of Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06124274 on ClinicalTrials.gov |
What this trial studies
This study aims to explore how oral contraceptives and different phases of the menstrual cycle influence muscle protein metabolism using a non-invasive ex vivo model. Participants will provide serum samples, which will be applied to mouse muscle cell cultures to assess the effects of hormonal changes on muscle growth. The study focuses on women who are either using monophasic oral contraceptives or have regular menstrual cycles, allowing for a comparison of protein processing in muscle cells under varying hormonal conditions.
Who should consider this trial
Good fit: Ideal candidates include women aged 18-35 with a BMI between 18.5-29.9, either using monophasic oral contraceptives for over three months or having regular menstrual cycles.
Not a fit: Patients with chronic diseases, recent cancer diagnoses, or those using certain medications that affect metabolism may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into how hormonal fluctuations affect muscle metabolism in women, potentially leading to better tailored fitness and health recommendations.
How similar studies have performed: While there is limited research specifically using ex vivo models for this purpose, studies on hormonal effects on muscle metabolism have shown promising results, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Toronto, Ontario
- Goldring Centre for High Performance Sport at the University of Toronto — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Daniel R Moore, PhD
- Email: dr.moore@utoronto.ca
- Phone: 4169464088
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.