Symptoms of Polycystic Ovarian Syndrome Ameliorated by Keto-Adaptation Pilot
Recruiting · NCT07227363 · Interventional (participants receive a specific treatment) · Lead sponsor: Ohio State University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The SPARK- Pilot study (Symptoms of PCOS Ameliorated by Responses to Keto-adaptation) is a 12-week clinical trial at The Ohio State University designed to explore how different ways of achieving ketosis may improve reproductive and metabolic health in women with Polycystic Ovary Syndrome (PCOS). Participants will be randomly assigned to one of two groups: * A ketogenic diet group, following a low-carbohydrate, nutrient-dense meal plan. * A mixed diet plus ketone supplement group, following general dietary guidelines while taking an exogenous ketone supplement. The study will measure whether these approaches help restore regular ovulation and improve hormone balance, metabolism, and overall well-being. Optional imaging using MRI will also examine heart and ovarian health. This pilot study will help researchers understand if ketogenic nutrition strategies are a safe, effective way to support menstrual regularity and reduce PCOS-related symptoms, providing groundwork for larger clinical trials.
Who can take part
Inclusion criteria
- Female participants aged 18-40 years.
- Clinical diagnosis of Polycystic Ovary Syndrome (PCOS) according to Rotterdam criteria (presence of at least two of the following: oligo- or anovulation, clinical or biochemical signs of hyperandrogenism, and/or polycystic ovaries on ultrasound).
- Willingness and ability to comply with all study procedures, including fasting (\>10 hours; water only), avoidance of alcohol (\>24 hours), and abstaining from exercise (\>24 hours) prior to each test visit.
- Willing to maintain current diet, exercise, medication, and supplement habits throughout the study.
- Body mass index (BMI) ≥18 kg/m².
- Access to a smartphone, computer, or tablet for digital tracking and study communication.
Exclusion criteria
- Current adherence to a low-carbohydrate diet (\<30% of total energy from carbohydrates).
- Non-PCOS etiologies of anovulation (e.g., menopause, oophorectomy, or other reproductive disorders).
- History of type 1 diabetes or uncontrolled type 2 diabetes.
- Weight loss ≥10% of body weight within the previous 6 months.
- Pregnancy or breastfeeding.
- Use of hormonal contraception or medications known to alter reproductive hormones within 3 months prior to enrollment.
- Active eating disorder or medical condition that could interfere with dietary intervention.
- Any condition that, in the opinion of the Investigator, could interfere with participation, data integrity, or safety.
Where it is running
1 location listed across 1 US state.
- The Ohio State University - Columbus, Ohio, United States