NCT07227363 · Ohio State University
Symptoms of Polycystic Ovarian Syndrome Ameliorated by Keto-Adaptation Pilot
((SPARK-Pilot))
What this study 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).
View original scientific description
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.
Interventions
OTHER
Ketogenic diet
A well-formulated ketogenic diet designed to achieve nutritional ketosis (β-hydroxybutyrate ≥0.5 mmol/L). The diet emphasizes non-starchy vegetables as the primary carbohydrate source (20-50 g/day), moderate protein intake (1.2-1.6 g/kg/day), and sufficient dietary fat for energy and satiety. All meals and snacks will be provided during the initial two weeks, followed by a self-guided phase with ongoing dietitian support and education materials. Participants will monitor daily fasting ketones and glucose using a handheld analyzer (KetoMojo).
DIETARY_SUPPLEMENT
Exogenous Ketone Supplement
A dietary supplement containing a ketone ester designed to elevate circulating β-hydroxybutyrate concentrations to nutritional ketosis levels without carbohydrate restriction. Participants will consume the supplement throughout the 12-week intervention while following a balanced, mixed diet consistent with USDA dietary guidelines.
Primary outcome measures
Change in Ovulatory Status
Time frame: Baseline to 12 weeks
To evaluate whether ketogenic dietary intervention or exogenous ketone supplementation restores ovulatory function in women with Polycystic Ovary Syndrome (PCOS). Ovulatory status will be assessed using a combination of validated measures, including basal body temperature monitoring via BBT, urinary luteinizing hormone (LH) surge detection using ovulation predictor kits, and serum progesterone levels. Participants will be classified as ovulatory or anovulatory based on hormonal and temperature cycle confirmation.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Columbus, Ohio
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 8, 2026 · Source of record for eligibility and locations