Combined Oral Contraceptive Pill and Resistance Starch

Phase 2

Not yet recruiting

• Conditions: Metabolic Syndrome; Polycystic Ovary Syndrome
• Interventions: Dietary Supplement: wheat dextrin; Drug: Oral Contraceptives, Low-Dose; Dietary Supplement: Maltodextrin

• Registration Number: NCT06852365
• Lead Sponsor: University of Pennsylvania

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-24
• Study First Submitted QC: 2025-02-24
• Last Update Submitted: 2025-02-24
• Study First Posted: 2025-02-28
• Last Update Posted: 2025-02-28
• Study Start: 2025-04
• Primary Completion: 2028-04
• Study Completion: 2028-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resistant Starch	wheat dextrin	wheat dextrin
Resistant Starch	Oral Contraceptives, Low-Dose	wheat dextrin
Placebo	Oral Contraceptives, Low-Dose	maltodextrin
Placebo	Maltodextrin	maltodextrin

Primary Outcome Measures

Name	Time	Method
Change in LDL-C measure	Baseline and 12 weeks
Change in fasting glucose measure	Baseline and 12 weeks
Change in BMI	Baseline and 12 weeks
Change in gut microbial diversity	Baseline and 12 weeks
Change in blood pressure	Baseline and 12 weeks
Change in SCFAs	Baseline and 12 weeks
Change in Bifidobacteria abundance	Baseline and 12 weeks

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States