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

Plain Language Summary

Simplified for easier understanding

This pilot study tests whether a ketogenic (very low-carb, high-fat) diet can reduce symptoms of polycystic ovary syndrome (PCOS) — a hormonal condition that causes irregular periods, excess androgens (male hormones), and sometimes infertility. **You may be eligible if...** - You are a woman between 18 and 40 years old - You have been clinically diagnosed with PCOS - You are willing to fast before test visits and track your diet - You have a smartphone or computer for digital tracking - Your BMI is 18 or above **You may NOT be eligible if...** - You already follow a very low-carbohydrate diet - Your irregular periods are caused by something other than PCOS (like menopause or other reproductive disorders) - You have type 1 diabetes or uncontrolled type 2 diabetes - You have lost 10% or more of your body weight in the past 6 months - You are pregnant, breastfeeding, or using hormonal contraception - You have an active eating disorder Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.