Pilot Study of Ketogenic Nutrition Approaches for Women Aged 18 to 40 with Polycystic Ovary Syndrome PCOS to Improve Ovulation and Metabolic Health

What this Trial Is About

Researchers are examining how different nutritional approaches to ketosis affect reproductive and metabolic health in women with Polycystic Ovary Syndrome PCOS. This 12-week pilot study aims to understand whether ketogenic strategies can restore regular ovulation and improve hormone balance, metabolism, and overall well-being in women aged 18-40 with PCOS. The study is conducted at The Ohio State University and seeks to provide preliminary data for future larger clinical trials. Participants will be randomly assigned to one of two groups a well-formulated ketogenic diet group focusing on low carbohydrates and high fat to maintain nutritional ketosis, and a mixed diet group following general dietary guidelines supplemented with an exogenous ketone ester. Both groups receive all meals and snacks for the first two weeks, then continue with self-guided adherence supported by dietitian guidance. Daily monitoring of ketone and glucose levels is performed using a handheld device. During the study, women will be assessed for changes in ovulatory status through hormonal markers, ovulation tests, and basal body temperature monitoring. Secondary measures include reproductive hormone levels, metabolic and lipid markers, and optional MRI imaging of heart and ovarian health. Researchers will track daily fasting ketones and glucose, serum hormone concentrations, and lipid profiles over the 12 weeks. The study includes digital tracking and requires participants to maintain consistent diet, exercise, medications, and supplements throughout the trial.

Symptoms of Polycystic Ovarian Syndrome Ameliorated by Keto-Adaptation Pilot