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This combination intervention is being evaluated in the CORS-PCOS Phase 2 clinical trial at the University of Pennsylvania. It consists of a standard low-dose oral contraceptive pill (containing 20 micrograms of ethinyl estradiol and 0.15 mg of desogestrel) supplemented with 15 grams per day of resistant starch derived from wheat dextrin. The study aims to treat Polycystic Ovary Syndrome (PCOS) and its associated metabolic syndrome in overweight or obese women. While oral contraceptives are a first-line treatment for managing the hormonal symptoms of PCOS, they can potentially exacerbate insulin resistance. The addition of wheat dextrin, a soluble prebiotic fiber, is intended to modulate the gut microbiota and promote the production of short-chain fatty acids (SCFAs) through colonic fermentation, thereby improving cardiometabolic parameters and addressing gut dysbiosis.
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