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

Detailed criteria

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 Supplement
wheat dextrin
participants will take 15 grams per day for 12 weeks
Drug
Oral Contraceptives, Low-Dose
20 micrograms ethinyl estradiol and desogestrel 0.15mg
Dietary Supplement
Maltodextrin
participants will take 15 grams per day for 12 weeks

Location

University of Pennsylvania
Philadelphia, Pennsylvania

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

Summary

Eligibility

Interventions

Location

Compensation

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Details

Conditions