RECRUITING

Combined Oral Contraceptive Pill and Resistance Starch

Conditions

Metabolic Syndrome Polycystic Ovary Syndrome

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-06

Study Completion:2028-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06852365

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 40 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	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 -

Inclusion Criteria

Exclusion 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.

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

Study Contact

Anuja Dokras, MD PhD

CONTACT

215-615-0085

adokras@pennmedicine.upenn.edu

Andrea Morley

CONTACT

215-615-4202

andrea.morley@pennmedicine.upenn.edu

Study Locations (Sites)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06

Study Completion Date2028-04

Study Record Updates

Study Start Date2025-06

Study Completion Date2028-04

Terms related to this study

Additional Relevant MeSH Terms

Metabolic Syndrome
Polycystic Ovary Syndrome