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

Resistant Starch Usage in Polycystic Ovary Syndrome: Impact on Cardiometabolic Dysfunction and the Gut Microbiome (CORS-PCOS)

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.

Study Overview

• Status: Recruiting
• Conditions: Polycystic Ovary Syndrome; Metabolic Syndrome
• Intervention / Treatment: Dietary supplement: wheat dextrin; Drug: Oral Contraceptives, Low-Dose; Dietary supplement: Maltodextrin

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Andrea Morley; Phone Number: 215-615-4202; Email: andrea.morley@pennmedicine.upenn.edu
• Study Contact Backup: Name: Anuja Dokras, MD PhD; Phone Number: 215-615-0085; Email: adokras@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
      • Contact: Andrea Morley; Phone Number: 215-615-4202; Email: andrea.morley@pennmedicine.upenn.edu
      • Contact: Anuja Dokras, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; maltodextrin	Drug: Oral Contraceptives, Low-Dose; 20 micrograms ethinyl estradiol and desogestrel 0.15mg; Dietary supplement: Maltodextrin; participants will take 15 grams per day for 12 weeks
Active Comparator: Resistant Starch; wheat dextrin	Dietary supplement: wheat dextrin; participants will take 15 grams per day for 12 weeks; Other Names: Benefiber; Drug: Oral Contraceptives, Low-Dose; 20 micrograms ethinyl estradiol and desogestrel 0.15mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in BMI	Baseline and 12 weeks
Change in LDL-C measure	Baseline and 12 weeks
Change in fasting glucose measure	Baseline and 12 weeks
Change in systolic blood pressure	Baseline and 12 weeks
Change in diastolic blood pressure	Baseline and 12 weeks
Change in Bifidobacteria abundance measured by quantitative polymerase chain reaction (q-PCR)	Baseline and 12 weeks
Change in Single Chain Fatty Acids (SCFA)	Baseline and 12 weeks

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: February 24, 2025
• First Submitted That Met QC Criteria: February 24, 2025
• First Posted (Actual): February 28, 2025

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Genital Diseases, Female; Glucose Metabolism Disorders; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Insulin Resistance; Hyperinsulinism; Ovarian Cysts; Cysts; Nutritional and Metabolic Diseases; Metabolic Syndrome; Polycystic Ovary Syndrome; Physiological Effects of Drugs; Reproductive Control Agents; Contraceptive Agents, Female; Contraceptive Agents; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Contraceptives, Oral; maltodextrin
• Other Study ID Numbers: 856886; 1R01HL173772-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No