NCT07227363 Symptoms of Polycystic Ovarian Syndrome Ameliorated by Keto-Adaptation Pilot
| NCT ID | NCT07227363 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ohio State University |
| Condition | PCOS (Polycystic Ovary Syndrome) |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-12-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2026-12-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Madison Kackley, PhD
PRINCIPAL INVESTIGATOR
Ohio State University
Frequently Asked Questions
Who can join the NCT07227363 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 40 Years, studying PCOS (Polycystic Ovary Syndrome). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07227363 currently recruiting?
Yes, NCT07227363 is actively recruiting participants. Contact the research team at Kackley.19@osu.edu for enrollment information.
Where is the NCT07227363 trial being conducted?
This trial is being conducted at Columbus, United States.
Who is sponsoring the NCT07227363 clinical trial?
NCT07227363 is sponsored by Ohio State University. The principal investigator is Madison Kackley, PhD at Ohio State University. The trial plans to enroll 40 participants.