Actively Recruiting
Resistant Starch Usage in Polycystic Ovary Syndrome: Impact on Cardiometabolic Dysfunction and the Gut Microbiome (CORS-PCOS)
Led by University of Pennsylvania · Updated on 2026-06-01
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Pennsylvania
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying women with Polycystic Ovary Syndrome (PCOS) to evaluate the effects of first-line therapy using oral contraceptive pills combined with either resistant starch or a placebo. The goal is to see if resistant starch can improve heart and metabolic health measures and affect gut bacteria compared to a placebo. This is a Phase 2 randomized trial focused on women aged 18 to 40 with PCOS and higher body weight. Participants will receive low-dose oral contraceptives containing ethinyl estradiol and desogestrel. Alongside, they will take either 15 grams daily of resistant starch (wheat dextrin) or a placebo (maltodextrin) for 12 weeks. The study uses a quadruple masking design to compare these two dietary supplements while all participants continue oral contraceptive treatment. During the study, participants will be monitored for changes in cholesterol levels, blood sugar, blood pressure, body mass index, and specific gut bacteria and fatty acids at the start and after 12 weeks. Researchers will collect biological samples and conduct clinical assessments to understand the impact of resistant starch on cardiometabolic health and gut microbiome. The total study duration for each participant is about 12 weeks of supplement intake alongside oral contraceptive use.
CONDITIONS
Brief Title
Combined Oral Contraceptive Pill and Resistance Starch
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 40 years
- BMI between 25 and 48 kg/m²
- Diagnosed with PCOS by Rotterdam criteria including chronic anovulation, androgen excess or hirsutism, and polycystic ovaries or elevated AMH
- Evidence of ovulatory dysfunction for those with more regular bleeding
- Women with hyperandrogenic PCOS phenotype
- Willingness to avoid pregnancy during the study period
You will not qualify if you...
- Pregnancy, lactation, untreated hypothyroidism, untreated hyperprolactinemia, or premature menopause
- Late onset adrenal hyperplasia
- History of bariatric surgery
- Inability to comply with study procedures due to mental illness, substance abuse, or other study participation
- Use of medications affecting weight or metabolism
- History of Crohn's disease or ulcerative colitis, current use of probiotics or laxatives
- Antibiotic use within 3 months prior to randomization
- Dietary fiber intake greater than 20 grams per day
- Medical conditions contraindicating use of oral contraceptives such as diabetes, liver or kidney disease, severe anemia, alcohol abuse, poorly controlled hypertension, high triglycerides, chronic inflammatory conditions, history of blood clots, heart disease, or certain cancers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants take either resistant starch (wheat dextrin) or placebo (maltodextrin) daily, along with low-dose oral contraceptives, for 12 weeks.
Visits at baseline and after 12 weeks
Trial Site Locations
Total: 1 location
1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
A
Anuja Dokras, MD PhD
A
Andrea Morley
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here