Combined Oral Contraceptive Pill and Resistance Starch
United States100 participantsStarted 2025-06-10
Plain-language 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.
Who can participate
Age range18 Years – 40 Years
SexFEMALE
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Change in LDL-C measure
Timeframe: Baseline and 12 weeks
2
Change in fasting glucose measure
Timeframe: Baseline and 12 weeks
3
Change in systolic blood pressure
Timeframe: Baseline and 12 weeks
4
Change in diastolic blood pressure
Timeframe: Baseline and 12 weeks
5
Change in BMI
Timeframe: Baseline and 12 weeks
6
Change in Bifidobacteria abundance measured by quantitative polymerase chain reaction (q-PCR)