Menstrual Cycle vs. Birth Control Pills for Protein Metabolism

(MCOC Trial)

Overseen By Ines Kortebi, PhD Candidate

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Toronto

Must be taking: Oral contraceptives

Must not be taking: NSAIDs, Anticoagulants, Statins, others

Disqualifiers: Chronic disease, Cancer, Smoking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different phases of the menstrual cycle and the use of birth control pills (oral contraceptives) affect protein metabolism, particularly in muscles. Understanding these effects may lead to improved training and nutrition advice for females. The trial seeks women who regularly lift weights and either use birth control pills or have a consistent menstrual cycle.

As an unphased study, this research offers a unique opportunity to contribute to scientific understanding and potentially enhance health recommendations for women.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that birth control pills are generally safe and well-tolerated. Many women use them to prevent pregnancy. While they can slightly affect cholesterol and blood sugar levels, these changes are usually minor. Most research indicates that they do not cause major health issues for most users.

The menstrual cycle is a natural process, and no evidence suggests safety concerns from experiencing normal menstrual phases.

Overall, using birth control pills and experiencing different menstrual phases is considered safe for most women. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different phases of the menstrual cycle and oral contraceptive use might impact protein metabolism in the body. Unlike standard care options that typically focus on hormone regulation or symptom management, this study aims to understand the metabolic differences between natural hormonal fluctuations and those induced by birth control pills. By comparing the mid-luteal and early follicular phases of the menstrual cycle with the active and placebo phases of oral contraceptives, the trial could uncover new insights into protein metabolism. This could potentially lead to more personalized healthcare approaches for women based on their hormonal cycles.

What evidence suggests that this trial's treatments could be effective for protein metabolism?

This trial will compare the effects of the menstrual cycle and the use of birth control pills on protein metabolism. Research has shown that birth control pills have little impact on metabolism or inflammation. Studies have found that these pills do not significantly alter energy expenditure or hunger regulation. In contrast, the menstrual cycle naturally changes hormone levels, potentially affecting protein processing. Exercise, particularly strength training, aids in muscle building, and these hormonal changes might influence muscle development. Understanding these differences can lead to improved exercise and nutrition plans for women. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for women interested in how their menstrual cycle or use of oral contraceptives affects muscle protein metabolism after resistance exercise. Participants should be healthy, not pregnant, and either have regular menstrual cycles or be taking birth control pills.

Inclusion Criteria

BMI between 18.5-29.9 kg/m2 (non-obese)

Recreationally active (resistance train minimum twice a week)

I am between 18 and 40 years old.

Exclusion Criteria

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Mid-Luteal Phase

Participants are assessed 5-9 days post-ovulation for muscle protein synthesis

8 hours

1 visit (in-person)

Early Follicular Phase

Participants are assessed on days 2-6 post-menses onset for muscle protein synthesis

8 hours

1 visit (in-person)

Active Pill Phase

Participants are assessed on days 10-20 of active pill for muscle protein synthesis

8 hours

1 visit (in-person)

Placebo Pill Phase

Participants are assessed at least 48 hours after the last active pill is taken for muscle protein synthesis

8 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the trial phases

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Menstrual Cycle vs. Oral Contraceptives

Trial Overview The study investigates the impact of natural menstrual cycles and oral contraceptive use on muscle protein synthesis after weightlifting. It involves consuming a protein beverage and using stable isotope tracers to measure protein turnover in muscles.

How Is the Trial Designed?

Group I: Placebo Pill Phase Experimental Treatment 3 Interventions

At least 48h after last active pill is taken

Group II: Mid-Luteal Phase Experimental Treatment 3 Interventions

5-9 days post-ovulation

Group III: Early Follicular Phase Experimental Treatment 3 Interventions

Days 2-6 post-menses onset

Group IV: Active Pill Phase Experimental Treatment 3 Interventions

Days 10-20 of active pill

Who Is Running the Clinical Trial?

University of Toronto

Lead Sponsor

Trials

739

Recruited

1,125,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5100613/

Effects of hormonal contraception on systemic metabolism Use of POCs has little effect on systemic metabolism and inflammation. Introduction. Use of hormonal contraception is widespread: around 80% of ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07258576?lastUpdPost=2020-03-16_

Menstrual Cycle vs. Oral Contraceptives: Effects on Muscle ... This will help us understand how menstrual cycle phases and oral contraceptive use influence MPS, providing insight into optimizing protein ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0026049521002195

Effect of oral contraceptives on energy balance in women There is no clear evidence that oral contraceptives affect energy expenditure. Oral contraceptive could influence food intake regulation by acting on CCK.

4. ec.bioscientifica.com ec.bioscientifica.com/view/journals/ec/9/10/EC-20-0423.xml

Effects of oral contraceptives on metabolic parameters in adult ... The antiandrogen progestins dienogest and cyproterone displayed the most favorable metabolic profile, while levonorgestrel displayed the least favorable.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/oby.21919

Oral Contraceptive Pill Alters Acute Dietary Protein‐ ... This study shows an absence of the greater thermic effect of HP versus NP in women taking the oral contraceptive pill and has important ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK430882/

Oral Contraceptive Pills - StatPearls - NCBI Bookshelf - NIH Currently, 3 types of oral contraceptive pills are broadly prescribed: combined estrogen-progesterone, progesterone-only, and continuous or extended-use pills.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0010782498000183

Safety Evaluation of Modern Oral Contraceptives Steroid hormones such as those present in oral contraceptives (OC) influence many aspects of human metabolism, including that of lipids, glucose, and insulin.

8. nejm.org nejm.org/doi/full/10.1056/NEJM199011153232003

The Effects of Different Formulations of Oral Contraceptive ... Oral contraceptives can induce changes in lipid and carbohydrate metabolism similar to those associated with an increased risk of coronary heart disease.