Trials / Recruiting
RecruitingNCT06852365
Combined Oral Contraceptive Pill and Resistance Starch
Resistant Starch Usage in Polycystic Ovary Syndrome: Impact on Cardiometabolic Dysfunction and the Gut Microbiome (CORS-PCOS)
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- University of Pennsylvania · Academic / Other
- Sex
- Female
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | wheat dextrin | participants will take 15 grams per day for 12 weeks |
| 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 |
Timeline
- Start date
- 2025-06-10
- Primary completion
- 2028-04-01
- Completion
- 2028-04-01
- First posted
- 2025-02-28
- Last updated
- 2026-02-19
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06852365. Inclusion in this directory is not an endorsement.