Resistant Starch Usage in Polycystic Ovary Syndrome: Impact on Cardiometabolic Dysfunction and the Gut Microbiome (CORS-PCOS)
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.
Arms & 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
Outcome measures
Primary
Change in LDL-C measure
Time frame: Baseline and 12 weeks
Change in fasting glucose measure
Time frame: Baseline and 12 weeks
Change in systolic blood pressure
Time frame: Baseline and 12 weeks
Change in diastolic blood pressure
Time frame: Baseline and 12 weeks
Change in BMI
Time frame: Baseline and 12 weeks
Change in Bifidobacteria abundance measured by quantitative polymerase chain reaction (q-PCR)
Time frame: Baseline and 12 weeks
Change in Single Chain Fatty Acids (SCFA)
Time frame: Baseline and 12 weeks
Eligibility criteria
Study locations (1)
University of Pennsylvania
Philadelphia, Pennsylvania, 19104