Combined Oral Contraceptive Pill and Resistance Starch (COR-PCOS)

University of Pennsylvania

Status and phase: Begins enrollment this month; Phase 2

Conditions: Polycystic Ovary Syndrome; Metabolic Syndrome

Treatments: Drug: Oral Contraceptives, Low-Dose; Dietary Supplement: Maltodextrin; Dietary Supplement: wheat dextrin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06852365

856886

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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 follicles or ovarian vol greater than 10cm3) or elevated AMH.
2. 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.
3. 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.
4. Subjects should be willing to avoid pregnancy for the entire duration of the study.

Exclusion criteria

1. Subjects with other causes for irregular menses such as pregnancy, lactation, untreated hypothyroidism, untreated hyperprolactinemia and premature menopause.

2. Subjects with late onset adrenal hyperplasia

3. Subjects with history of bariatric surgery

4. Those who are unable to comply with the study procedures, for instance due to mental illness, substance abuse, or participation in other studies.

5. Subjects taking medications that affect weight or metabolic parameters (e.g. lipid lowering medications).

6. History of Crohn's disease and ulcerative colitis as well as current use of probiotics and laxatives are excluded.

7. Subjects could not have taken antibiotics for at least 3 months prior to randomization visit.

8. Subjects with greater than 20 g/day of dietary fiber intake based on pre-screening ASA-24 survey will be excluded.

9. Subjects with medical conditions that are contraindications to use of OCP and other medical conditions such as:

   1. Type 1 or 2 diabetes
   2. liver disease or dysfunctional liver (AST/ALT greater than 2x normal or a total bilirubin greater than 2.5 mg/dL)
   3. renal disease (BUN greater than 30 mg/dL or serum creatinine greater than 1.4 mg/dL)
   4. severe anemia (hemoglobin less than 10 mg/dL)
   5. alcohol abuse
   6. poorly controlled hypertension
   7. TG greater than 250 mg/dl
   8. chronic inflammatory conditions such as psoriasis
   9. history of deep venous thrombosis, pulmonary embolus, or cerebrovascular accident; known heart disease (New York Heart Association Class II or higher)
   10. history of cervical carcinoma, endometrial carcinoma, or breast carcinoma, adrenal or ovarian tumor secreting androgens, and Cushing's syndrome -

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Resistant Starch

Active Comparator group

Description:

wheat dextrin

Treatment:

Dietary Supplement: wheat dextrin

Drug: Oral Contraceptives, Low-Dose

Placebo

Placebo Comparator group

Description:

maltodextrin

Treatment:

Dietary Supplement: Maltodextrin

Drug: Oral Contraceptives, Low-Dose