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
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.
CONDITIONS
Official Title
Symptoms of Polycystic Ovarian Syndrome Ameliorated by Keto-Adaptation Pilot
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants aged 18-40 years
- Clinical diagnosis of Polycystic Ovary Syndrome (PCOS) based on Rotterdam criteria (at least two of: oligo- or anovulation, signs of hyperandrogenism, or polycystic ovaries on ultrasound)
- Willing and able to follow all study procedures including fasting >10 hours, avoiding alcohol >24 hours, and abstaining from exercise >24 hours before test visits
- Willing to keep current diet, exercise, medications, and supplements unchanged during the study
- Body mass index (BMI) of 18 kg/m² or higher
- Access to a smartphone, computer, or tablet for study communication and digital tracking
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 (e.g., menopause, oophorectomy, other reproductive disorders)
- History of type 1 diabetes or uncontrolled type 2 diabetes
- Weight loss of 10% or more of body weight in the past 6 months
- Pregnancy or breastfeeding
- Use of hormonal contraception or reproductive hormone-altering medications within 3 months before enrollment
- Active eating disorder or medical condition that could interfere with dietary intervention
- Any condition that might interfere with study participation, data integrity, or safety as judged by the Investigator
AI-Screening
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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
CONTACT
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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