RecruitingPhase 2NCT06852365

Combined Oral Contraceptive Pill and Resistance Starch

Resistant Starch Usage in Polycystic Ovary Syndrome: Impact on Cardiometabolic Dysfunction and the Gut Microbiome (CORS-PCOS)


Sponsor

University of Pennsylvania

Enrollment

100 participants

Start Date

Jun 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study will enroll women with PCOS to study the effects of first line therapy, oral contraceptive pills, and then either 12 weeks of resistant starch or 12 weeks of placebo to explore if resistant starch improves cardiometabolic parameters or impacts gut dysbiosis compared to placebo.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding a dietary fiber supplement (resistant starch) to the birth control pill improves hormonal and metabolic health in women with polycystic ovary syndrome (PCOS). **You may be eligible if:** - You are a woman between 18 and 40 years old - You have been diagnosed with PCOS (with irregular periods, high androgen levels, or polycystic ovaries on ultrasound) - Your BMI is between 25 and 48 - You are willing to avoid pregnancy for the entire study duration - You are not currently taking any medication that affects weight or metabolism **You may NOT be eligible if:** - You have another reason for irregular periods (e.g., thyroid issues, elevated prolactin, early menopause) - You have had bariatric (weight loss) surgery - You have type 1 or type 2 diabetes - You have liver or kidney disease - You have a history of blood clots, stroke, or serious heart disease - You have a history of breast, cervical, or endometrial cancer - You currently take probiotics, laxatives, or have recently used antibiotics (within 3 months) - You eat more than 20 grams of fiber per day - You have Crohn's disease or ulcerative colitis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTwheat dextrin

participants will take 15 grams per day for 12 weeks

DRUGOral Contraceptives, Low-Dose

20 micrograms ethinyl estradiol and desogestrel 0.15mg

DIETARY_SUPPLEMENTMaltodextrin

participants will take 15 grams per day for 12 weeks


Locations(1)

University of Pennsylvania

Philadelphia, Pennsylvania, United States

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NCT06852365


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