Keto-adaptation to improve PCOS symptoms and ovulation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This 12-week randomized, two-arm pilot will enroll 40 women aged 18–40 with PCOS to compare a ketogenic diet versus a mixed diet plus an exogenous ketone supplement for achieving nutritional ketosis. One group will follow a low-carbohydrate, high-fat ketogenic meal plan targeting blood ketones ≥0.5 mmol/L, while the other will follow general dietary guidelines and take a ketone ester supplement. Primary outcomes are ovulatory status captured by hormonal markers, ovulation prediction tests, and continuous basal body temperature monitoring (OvuSense), with secondary outcomes including reproductive hormones, metabolic and lipid markers, and optional cardiac and ovarian MRI. The pilot is designed to determine safety, feasibility, and signals of efficacy to guide larger trials on dietary ketosis for menstrual regularity and PCOS symptom improvement.

Why it matters

Who can join: the full rules

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 it's running

• The Ohio State University
  Columbus, Ohio, United States Recruiting

Study contacts

• Principal investigator: Madison Kackley, PhD — Ohio State University
• Study coordinator: Madison Kackley, PhD
• Email: Kackley.19@osu.edu
• Phone: 16142479650

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.