Low‑dose oral contraceptives plus resistant starch for metabolic health in PCOS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adult women with PCOS and BMI 25–48 kg/m² will start low‑dose combined oral contraceptives and be randomized to 12 weeks of a resistant starch supplement or a placebo. Investigators will measure cardiometabolic parameters such as insulin sensitivity, lipids, and blood pressure and will analyze changes in gut microbiome composition before and after the intervention. Eligibility is defined by Rotterdam criteria for PCOS, including chronic anovulation, hyperandrogenism, and/or polycystic ovarian morphology or elevated AMH. Supplements include resistant starch formulations (e.g., wheat dextrin) with a maltodextrin placebo, and all visits take place at the University of Pennsylvania.

Why it matters

Who can join: the full rules

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 -

Where it's running

• University of Pennsylvania
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Study coordinator: Anuja Dokras, MD PhD
• Email: adokras@pennmedicine.upenn.edu
• Phone: 215-615-0085

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Effect of a nutritional supplement on women with Polycystic Ovary Syndrome

  This study is testing whether a nutritional supplement can help women with Polycystic Ovary Syndrome feel better and improve their health.

  Recruiting Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana · Valencia, Valencia · NCT06551285

• Lifestyle medicine program to help rural adults with multiple chronic conditions

  This program will try supervised exercise and lifestyle coaching for rural adults aged 18–64 who have two or more chronic conditions to see if access to a wellness facility improves their health.

  Recruiting West Virginia School of Osteopathic Medicine · Lewisburg, West Virginia · NCT06049420

• Investigating fasting insulin and insulin resistance across different demographics

  This study looks at how fasting insulin levels and insulin resistance vary among different groups of people based on age, sex, race, weight, and conditions like PCOS to better understand metabolic health.

  Recruiting Lilli Health · Houston, Texas · NCT05950282

• Fulvic acid supplements for metabolic syndrome

  This study tests whether 50 mg or 100 mg of fulvic acid daily for 12 weeks can help people with metabolic syndrome or prediabetes.

  Recruiting Arizona State University · Phoenix, Arizona · NCT07927283

• Asprosin and miRNA Profiles in Young Women with Metabolic Syndrome

  This study tests whether certain blood biomarkers, including asprosin and six microRNAs, differ between young women with metabolic syndrome and healthy peers.

  Recruiting University of Applied Sciences in Nowy Targ · Nowy Targ, Lesser Poland Voivodeship · NCT07917364

• Using Multimodal Ultrasound to Check Muscle Mass in Metabolic Disease Patients

  This study tests whether a multimodal ultrasound approach can accurately measure muscle mass in people with metabolic syndrome, obesity, sarcopenia, or type 2 diabetes.

  Recruiting Zhangzhou Municipal Hospital · Zhangzhou, Fujian · NCT07836088

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.