Combined Oral Contraceptive Pill and Resistance Starch

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified December 2025 by University of Pennsylvania
Sponsor
University of Pennsylvania
Information Provided by (Responsible Party)
Anuja Dokras
Clinicaltrials.gov Identifier
NCT06852365
Other Study ID Numbers:
856886
First Submitted
February 23, 2025
First Posted
February 27, 2025
Last Update Posted
February 18, 2026
Last Verified
December 2025

ClinicalTrials.gov processed this data on February 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Metabolic SyndromePolycystic Ovary Syndrome
Dietary Supplement: wheat dextrinDrug: Oral Contraceptives, Low-Dose

Study Design

Study TypeInterventional
Actual Enrollment100 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeOther
Official TitleResistant Starch Usage in Polycystic Ovary Syndrome: Impact on Cardiometabolic Dysfunction and the Gut Microbiome (CORS-PCOS)
Study Start DateJune 9, 2025
Actual Primary Completion Date1yr 11mos from now
Actual Study Completion Date1yr 11mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Resistant Starch
wheat dextrin
Dietary Supplement: wheat dextrin
participants will take 15 grams per day for 12 weeks
Placebo
maltodextrin
Drug: Oral Contraceptives, Low-Dose
20 micrograms ethinyl estradiol and desogestrel 0.15mg

Outcome Measures

Primary Outcome Measures
  1. Change in LDL-C measure
  2. Change in fasting glucose measure
  3. Change in systolic blood pressure
  4. Change in diastolic blood pressure
  5. Change in BMI
  6. Change in Bifidobacteria abundance measured by quantitative polymerase chain reaction (q-PCR)
  7. Change in Single Chain Fatty Acids (SCFA)

Eligibility Criteria

Ages Eligible for Study(Adult)
Sexes Eligible for StudyFemale
Accepts Healthy VolunteersNo
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 -

Contacts and Locations

Sponsors and CollaboratorsUniversity of Pennsylvania
Locations
University of Pennsylvania | Philadelphia Pennsylvania, United States, 19104