Combined Oral Contraceptive Pill and Resistance Starch for PCOS

This study is for women aged 18-40 with Polycystic Ovary Syndrome (PCOS), a condition affecting hormone levels and metabolism. You must also have a Body Mass Index (BMI) between 25 and 48. The study aims to see if adding a dietary supplement, either wheat dextrin (a type of resistant starch) or maltodextrin (a placebo), to a common birth control pill (20 micrograms ethinyl estradiol and 0.15mg desogestrel) can improve health markers. Researchers will measure changes in your 'bad' cholesterol (LDL-C), fasting blood sugar, and blood pressure over 12 weeks to see if the resistant starch helps more than the placebo. The study plans to enroll 100 participants, but its current recruitment status is unclear.

Study design
This interventional study will enroll 100 women with PCOS to compare the effects of a birth control pill combined with either resistant starch or a placebo.
What's involved
Participants will take a birth control pill and a dietary supplement (either wheat dextrin or maltodextrin) daily for 12 weeks. Your LDL-C, fasting glucose, and systolic blood pressure will be measured at the beginning and end of this 12-week period.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 weeks, with measurements taken at baseline and at the end of this period.

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NCT06852365

Combined Oral Contraceptive Pill and Resistance Starch

Recruiting
PHASE2Ages 18–40InterventionalPrevention
University of Pennsylvania
~100 participants
Updated 2026-06-01 on ClinicalTrials.gov
What's tested:wheat dextrinOral Contraceptives, Low-DoseMaltodextrin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in LDL-C measure
Measured over Baseline and 12 weeks
+6 more outcomes measured
Metabolic Syndrome
Polycystic Ovary Syndrome
1 sites across 1 states
Pennsylvania1

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  • Change in LDL-C measureBaseline and 12 weeks
  • Change in fasting glucose measureBaseline and 12 weeks
  • Change in systolic blood pressureBaseline and 12 weeks
  • Change in diastolic blood pressureBaseline and 12 weeks
  • Change in BMIBaseline and 12 weeks
  • Change in Bifidobacteria abundance measured by quantitative polymerase chain reaction (q-PCR)Baseline and 12 weeks
  • Change in Single Chain Fatty Acids (SCFA)Baseline and 12 weeks