NCT07227363Recruiting
Symptoms of Polycystic Ovarian Syndrome Ameliorated by Keto-Adaptation Pilot
Source: ClinicalTrials.gov · Last updated 8 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 6 Nov 2025
- Start date
- 1 Dec 2026
- Primary completion date
- Dec 2026
- Lead sponsor
- Ohio State University
- NCT number
- NCT07227363
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 1 Dec 2026 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Weight loss ≥10% of body weight within the previous 6 months.
- Use of hormonal contraception or medications known to alter reproductive hormones within 3 months prior to enrollment.
Other illness
- Non-PCOS etiologies of anovulation (e.g., menopause, oophorectomy, or other reproductive disorders).
- History of type 1 diabetes or uncontrolled type 2 diabetes.
- 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.
Other
- Current adherence to a low-carbohydrate diet (\<30% of total energy from carbohydrates).
- Pregnancy or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to 40 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Ohio State University Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.