Combined Oral Contraceptive Pill and Resistance Starch

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT06852365
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Metabolic Syndrome
  • Polycystic Ovary Syndrome

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • wheat dextrin — DIETARY_SUPPLEMENT
    participants will take 15 grams per day for 12 weeks
  • Oral Contraceptives, Low-Dose — DRUG
    20 micrograms ethinyl estradiol and desogestrel 0.15mg
  • Maltodextrin — DIETARY_SUPPLEMENT
    participants will take 15 grams per day for 12 weeks

Study Details

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.

Key Dates

Start date
Jun 10, 2025
Status verified
May 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Resistant Starch
    wheat dextrin
  • Placebo Comparator: Placebo
    maltodextrin

Primary Outcome Measure

Change in LDL-C measure [ Time Frame: Baseline and 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of PennsylvaniaPhiladelphiaPennsylvania19104
Anuja Dokras, MD PhD
Andrea Morley
[email protected]
215-615-4202

Find similar trials in Philadelphia, PA

By research site
University of Pennsylvania· Philadelphia, PA

Related Studies