Actively Recruiting
Symptoms of Polycystic Ovarian Syndrome Ameliorated by Keto-Adaptation Pilot
Led by Ohio State University · Updated on 2026-05-08
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are examining how different nutritional approaches to ketosis affect reproductive and metabolic health in women with Polycystic Ovary Syndrome (PCOS). This 12-week pilot study aims to understand whether ketogenic strategies can restore regular ovulation and improve hormone balance, metabolism, and overall well-being in women aged 18-40 with PCOS. The study is conducted at The Ohio State University and seeks to provide preliminary data for future larger clinical trials. Participants will be randomly assigned to one of two groups: a well-formulated ketogenic diet group focusing on low carbohydrates and high fat to maintain nutritional ketosis, and a mixed diet group following general dietary guidelines supplemented with an exogenous ketone ester. Both groups receive all meals and snacks for the first two weeks, then continue with self-guided adherence supported by dietitian guidance. Daily monitoring of ketone and glucose levels is performed using a handheld device. During the study, women will be assessed for changes in ovulatory status through hormonal markers, ovulation tests, and basal body temperature monitoring. Secondary measures include reproductive hormone levels, metabolic and lipid markers, and optional MRI imaging of heart and ovarian health. Researchers will track daily fasting ketones and glucose, serum hormone concentrations, and lipid profiles over the 12 weeks. The study includes digital tracking and requires participants to maintain consistent diet, exercise, medications, and supplements throughout the trial.
CONDITIONS
Brief Title
Symptoms of Polycystic Ovarian Syndrome Ameliorated by Keto-Adaptation Pilot
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants aged 18 to 40 years
- Clinical diagnosis of Polycystic Ovary Syndrome (PCOS) based on Rotterdam criteria (at least two of: oligo- or anovulation, hyperandrogenism, or polycystic ovaries on ultrasound)
- Willingness and ability to comply with fasting (>10 hours), alcohol avoidance (>24 hours), and exercise abstinence (>24 hours) before test visits
- Willing to maintain current diet, exercise, medications, and supplements during the study
- Body mass index (BMI) of 18 kg/m² or higher
- Access to a smartphone, computer, or tablet for digital tracking and communication
You will not qualify if you...
- Currently following a low-carbohydrate diet with less than 30% of total energy from carbohydrates
- Anovulation due to non-PCOS causes such as menopause, oophorectomy, or other reproductive disorders
- History of type 1 diabetes or uncontrolled type 2 diabetes
- Weight loss of 10% or more in the past 6 months
- Pregnancy or breastfeeding
- Use of hormonal contraception or medications affecting reproductive hormones within 3 months prior to enrollment
- Active eating disorder or medical conditions interfering with diet intervention
- Any condition that could interfere with participation, data integrity, or safety as judged by the Investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants follow a dietary intervention for 12 weeks, either a ketogenic diet designed to achieve nutritional ketosis or a balanced mixed diet with an exogenous ketone supplement. Initial meals and snacks are provided for 2 weeks, followed by self-guided adherence with dietitian support. Participants monitor daily fasting ketones and glucose.
Weekly visits for up to 12 weeks
Trial Site Locations
Total: 1 location
1
The Ohio State University
Columbus, Ohio, United States, 43210-1442
Actively Recruiting
Research Team
M
Madison Kackley, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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