Resistant Starch Usage in Polycystic Ovary Syndrome: Impact on Cardiometabolic Dysfunction and the Gut Microbiome (CORS-PCOS)
University of Pennsylvania
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
- Age range
- 18–40 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 1. Women between ages of 18-40 years with BMI greater than or equal to 25 kg/m² to less than or equal to 48 kg/m² diagnosed with PCOS defined by the Rotterdam criteria based on a history of chronic anovulation (8 or fewer periods), androgen excess \[defined as total serum testosterone, free testosterone or a FAI greater than or equal to 90% of the upper limit of normal) or hirsutism (Ferriman-Gallwey score greater than 6 for Hispanics/ Black and greater than or equal to 2 for women of Asian descent)\] and polycystic ovaries as defined by a pelvic ultrasound (20 or more fol…
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
Location
- University of PennsylvaniaPhiladelphia, Pennsylvania