Symptoms of Polycystic Ovarian Syndrome Ameliorated by Keto-Adaptation Pilot

Recruiting now · Not applicable

Conditions studied: PCOS (Polycystic Ovary Syndrome)

In brief

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.

Key facts

Study ID

NCT07227363

Run by

Ohio State University

People needed

40

Starts

2026-12-01

Expected to finish

2026-12-01

Last updated by the study team

2026-05-08

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• The Ohio State University — Columbus, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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