RecruitingNot ApplicableNCT07227363

Symptoms of Polycystic Ovarian Syndrome Ameliorated by Keto-Adaptation Pilot

Sponsor

Ohio State University

Enrollment

40 participants

Start Date

Feb 1, 2025

Study Type

INTERVENTIONAL

Conditions

PCOS (Polycystic Ovary Syndrome)

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 40 Years

Inclusion Criteria6

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 Criteria8

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.

Interventions

OTHERKetogenic diet

A well-formulated ketogenic diet designed to achieve nutritional ketosis (β-hydroxybutyrate ≥0.5 mmol/L). The diet emphasizes non-starchy vegetables as the primary carbohydrate source (20-50 g/day), moderate protein intake (1.2-1.6 g/kg/day), and sufficient dietary fat for energy and satiety. All meals and snacks will be provided during the initial two weeks, followed by a self-guided phase with ongoing dietitian support and education materials. Participants will monitor daily fasting ketones and glucose using a handheld analyzer (KetoMojo).

DIETARY_SUPPLEMENTExogenous Ketone Supplement

A dietary supplement containing a ketone ester designed to elevate circulating β-hydroxybutyrate concentrations to nutritional ketosis levels without carbohydrate restriction. Participants will consume the supplement throughout the 12-week intervention while following a balanced, mixed diet consistent with USDA dietary guidelines.