Study of Oral Contraceptive Pills and Resistant Starch in Women with Polycystic Ovary Syndrome to Improve Heart and Metabolic Health

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.

Combined Oral Contraceptive Pill and Resistance Starch