RecruitingNot Applicable

Symptoms of Polycystic Ovarian Syndrome Ameliorated by Keto-Adaptation Pilot

United States40 participantsStarted 2026-12-01

Plain-language 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.

Who can participate

Age range

18 Years – 40 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Ovulatory Status

Timeframe: Baseline to 12 weeks

Trial details

NCT IDNCT07227363

SponsorOhio State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Madison Kackley, PhD

16142479650 Kackley.19@osu.edu

View on ClinicalTrials.gov More PCOS (Polycystic Ovary Syndrome) trials