About this trial
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 criteria
Qualifiers
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 follicles or ovarian vol greater than 10cm3) or elevated AMH.
For women with more regular bleeding patterns, but who are suspected to be experiencing periodic anovulatory bleeding, a midluteal progesterone (P4) level less than 3ng/dL will be evidence of ovulatory dysfunction and qualify as anovulation.
Women with only hyperandrogenic PCOS phenotype (hyperandrogenism + one more criteria) will be included to decrease the heterogeneity of the cohort and as metabolic risks are increased in these women compared to normo-androgenic women with PCOS.
Subjects should be willing to avoid pregnancy for the entire duration of the study.
Disqualifiers
Subjects with other causes for irregular menses such as pregnancy, lactation, untreated hypothyroidism, untreated hyperprolactinemia and premature menopause.
Subjects with late onset adrenal hyperplasia
Subjects with history of bariatric surgery
Those who are unable to comply with the study procedures, for instance due to mental illness, substance abuse, or participation in other studies.
Trial design
Treatments tested in this trial
- wheat dextrin
- Oral Contraceptives, Low-Dose
- Maltodextrin
Treatment groups
Sponsors and collaborators
University of Pennsylvania
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator