Keto-adaptation to improve PCOS symptoms and ovulation
Symptoms of Polycystic Ovarian Syndrome Ameliorated by Keto-Adaptation Pilot
NA · Ohio State University · NCT07227363
This 12-week trial will test whether a ketogenic diet or taking exogenous ketones helps women with PCOS restore regular ovulation and improve hormone and metabolic health.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Ohio State University (other) |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT07227363 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Women aged 18–40 with a clinical diagnosis of PCOS by Rotterdam criteria, BMI ≥18 kg/m², willing to follow study diet/ supplement plans and tracking procedures, and able to attend visits at Ohio State University are ideal candidates.
Not a fit: People already following a low-carbohydrate diet, those with non-PCOS causes of anovulation, or with contraindicated conditions (e.g., type 1 diabetes) are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, these approaches could help restore regular ovulation and improve hormone balance and metabolic health for women with PCOS.
How similar studies have performed: Small prior studies and clinical reports suggest ketogenic diets can improve insulin sensitivity and some hormone measures, but direct evidence that they restore ovulation in PCOS is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Columbus, Ohio
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: PCOS, Ketogenic Diet, Exogenous Ketones, Nutritional Ketosis, Reproductive Hormones, Ovarian Function, Women's Health, Metabolic Health