Recruiting

Keto-adaptation

Sponsor:

Ohio State University

Code:

NCT07227363

Conditions

PCOS (Polycystic Ovary Syndrome)

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Not accepted

Interventions

Ketogenic diet

Exogenous Ketone Supplement

Study Details

Brief 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.

Conditions

PCOS (Polycystic Ovary Syndrome)

Study ID

NCT07227363

Start date

Dec 1, 2026

Status verified date

May, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Ketogenic Diet (KD)

Participants in this arm will follow a well-formulated ketogenic diet designed to achieve and maintain nutritional ketosis (β-hydroxybutyrate ≥0.5 mmol/L). The diet will include non-starchy vegetables as the primary carbohydrate source (20-50 g/day), moderate protein (1.2-1.6 g/kg/day), and sufficient fat for energy and satiety. All meals and snacks will be provided for the first 2 weeks, followed by self-guided adherence with support from the study dietitian and educational resources. Daily fingerstick ketone and glucose levels will be monitored using KetoMojo.

active comparator: Mixed Diet + Exogenous Ketone Supplement

Participants in this arm will follow a balanced, mixed diet aligned with USDA macronutrient recommendations while consuming an exogenous ketone supplement throughout the 12-week intervention. The supplement is designed to raise circulating β-hydroxybutyrate to nutritional ketosis levels without carbohydrate restriction. As with the KD arm, all meals and snacks will be provided for the first 2 weeks, followed by self-guided adherence with ongoing dietitian support.

Interventions

Ketogenic 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).

Exogenous 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.

Primary outcome measure

  • Change in Ovulatory Status [ Time Frame: Baseline to 12 weeks ]

Central Contacts and Locations

Central contacts

Madison Kackley, PhD

16142479650Kackley.19@osu.edu

Locations

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210-1442

Contacts

Madison Kackley

6142479650Kackley.19@osu.edu

More Information

Sponsor

Ohio State University

Last update posted

May 8, 2026

Last verified

May, 2026

Keywords

  • Ketogenic Diet
  • Exogenous Ketones
  • Nutritional Ketosis
  • Reproductive Hormones
  • Ovarian Function
  • Women's Health
  • Metabolic Health
  • PCOS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-05-08.