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SPARK-Pilot Study: Keto-Adaptation for PCOS Symptoms

This 12-week study at The Ohio State University is looking at how different ways of achieving "ketosis" (a metabolic state where your body burns fat for fuel) might help women with Polycystic Ovary Syndrome (PCOS). You would be randomly assigned to one of two groups: either a ketogenic diet (low-carbohydrate, nutrient-dense meals) or a mixed diet along with an exogenous ketone supplement (a dietary supplement that raises ketone levels). The main goal is to see if these approaches can help restore regular ovulation. Researchers will also look at how these methods affect your hormones, metabolism, and overall well-being. This study is currently recruiting women aged 18-40 who have been diagnosed with PCOS.

Study design
This is a 12-week randomized study with two groups, aiming to enroll 40 women. It compares a ketogenic diet to a mixed diet with a ketone supplement.
What's involved
Participants will follow a specific diet or take a supplement for 12 weeks. Ovulation will be tracked using hormonal markers, prediction tests, and continuous basal body temperature monitoring.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 12 weeks, which is the duration of the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07227363

Symptoms of Polycystic Ovarian Syndrome Ameliorated by Keto-Adaptation Pilot

Recruiting
NAAges 18–40InterventionalBasic science
Ohio State University
~40 participants
Updated 2026-05-08 on ClinicalTrials.gov
What's tested:Ketogenic dietExogenous Ketone Supplement

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Ovulatory Status
Measured over Baseline to 12 weeks

Conditions

PCOS (Polycystic Ovary Syndrome)

Explore related trials

Polycystic Ovary Syndrome

NCT07227363

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • The Ohio State University

    Columbus, Ohiostudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Madison Kackley, PhD · PRINCIPAL_INVESTIGATOR · Ohio State University

Who to contact

Madison Kackley, PhD
[email protected]
16142479650
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Change in Ovulatory StatusBaseline 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.