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NCT Number: NCT07227363

Symptoms of Polycystic Ovarian Syndrome Ameliorated by Keto-Adaptation Pilot

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.

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Key information

Conditions

PCOS (Polycystic Ovary Syndrome) Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University

Columbus, Ohio, 43210-1442, United States

Location status: Recruiting

Location contact

Madison Kackley

CONTACT

[email protected]

6142479650

About this study

The SPARK study (Symptoms of PCOS Ameliorated by Responses to Keto-adaptation) is a 12-week randomized, two-arm intervention examining how nutritional ketosis influences ovulatory and metabolic outcomes in women with Polycystic Ovary Syndrome (PCOS).

PCOS is a common endocrine disorder that affects hormone balance, menstrual function, and metabolism. Current treatments often address single symptoms but rarely provide comprehensive improvement. Ketogenic dietary interventions have shown promise for improving insulin sensitivity, hormone profiles, and body composition; however, few studies have evaluated their direct impact on ovulation.

In this pilot trial, 40 women aged 18-40 years with diagnosed PCOS will be randomized to one of two groups:

Ketogenic Diet (KD): Participants will follow a low-carbohydrate, high-fat, moderate-protein diet designed to achieve and maintain nutritional ketosis (β-hydroxybutyrate ≥0.5 mmol/L).

Mixed Diet + Exogenous Ketone Supplement: Participants will consume a balanced diet aligned with USDA macronutrient recommendations and receive a ketone ester supplement.

Primary outcomes include changes in ovulatory status, assessed through hormonal markers, ovulation prediction tests, and continuous basal body temperature monitoring (OvuSense). Secondary outcomes include changes in reproductive hormones (progesterone, estrogen, LH, FSH), metabolic and lipid markers, and exploratory imaging of cardiovascular function and ovarian morphology via MRI.

This study will provide feasibility and preliminary efficacy data to inform a future large-scale clinical trial evaluating ketogenic strategies for improving menstrual regularity and overall health in women with PCOS.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ketogenic diet

Other

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

Dietary 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 outcomes

  1. Change in Ovulatory Status

    Time frame: Baseline to 12 weeks

    To evaluate whether ketogenic dietary intervention or exogenous ketone supplementation restores ovulatory function in women with Polycystic Ovary Syndrome (PCOS). Ovulatory status will be assessed using a combination of validated measures, including basal body temperature monitoring via BBT, urinary luteinizing hormone (LH) surge detection using ovulation predictor kits, and serum progesterone levels. Participants will be classified as ovulatory or anovulatory based on hormonal and temperature cycle confirmation.

Secondary outcomes

  1. Change in Serum Progesterone Concentration (ng/mL)

    Time frame: Baseline to 12 weeks

    To determine the effects of ketogenic diet and exogenous ketone supplementation on circulating reproductive hormone concentrations. Serum progesterone will be analyzed using standard immunoassay techniques (Quest Diagnostics panels and/or validated ELISA assays). Hormonal changes will be compared between baseline and post-intervention to assess improvements in reproductive axis regulation.

  2. Change in Serum Estradiol Concentration (pg/mL)

    Time frame: Baseline to 12 weeks

    To determine the effects of ketogenic diet and exogenous ketone supplementation on circulating reproductive hormone concentrations. Serum estradiol will be analyzed using commercially available immunoassay kits (Quest Diagnostics panels and/or validated ELISA assays). Hormonal changes will be compared between baseline and post-intervention to assess improvements in reproductive axis regulation.

  3. Change in Serum Luteinizing Hormone Concentration (mIU/mL)

    Time frame: Baseline to 12 weeks

    To determine the effects of ketogenic diet and exogenous ketone supplementation on circulating reproductive hormone concentrations. Serum luteinizing hormone (LH) will be analyzed using standard immunoassay techniques (Quest Diagnostics panels and/or validated ELISA assays). Hormonal changes will be compared between baseline and post-intervention to assess improvements in reproductive axis regulation.

  4. Change in Serum Follicle Stimulating Hormone Concentrations (mIU/mL)

    Time frame: Baseline to 12 weeks

    To determine the effects of ketogenic diet and exogenous ketone supplementation on circulating reproductive hormone concentrations. Serum follicle-stimulating hormone (FSH) will be analyzed using standard immunoassay techniques (Quest Diagnostics panels and/or validated ELISA assays). Hormonal changes will be compared between baseline and post-intervention to assess improvements in reproductive axis regulation.

  5. Change in Daily Fasting BHB (mmol/L)

    Time frame: Baseline to 12 weeks (Daily)

    To assess changes in metabolic parameters including fasting β-hydroxybutyrate (BHB). Capillary ketones will be measured daily using KetoMojo handheld monitors.

  6. Change in Daily Fasting Glucose (mg/dL)

    Time frame: Baseline to 12 weeks (Daily)

    To assess changes in metabolic parameters including fasting glucose. Capillary glucose will be measured daily using KetoMojo handheld monitors.

  7. Change in Serum Insulin Concentration (µIU/mL)

    Time frame: Baseline to 12 weeks

    To assess the effect of ketogenic diet and exogenous ketone supplementation on fasting insulin levels. Serum insulin will be measured at laboratory visits via immunoassay (Quest Diagnostics or validated ELISA). Mean change from baseline will be compared across groups.

  8. Change in Serum Total Cholesterol Concentration (mg/dL)

    Time frame: Baseline to 12 weeks

    To assess changes in fasting serum total cholesterol in response to ketogenic diet and exogenous ketone supplementation. Blood samples will be collected biweekly and analyzed using standard clinical chemistry methods (Quest Diagnostics). Mean change from baseline to 12 weeks will be reported.

  9. Change in Serum Triglyceride Concentration (mg/dL)

    Time frame: Baseline to 12 weeks

    To determine the effect of ketogenic diet and exogenous ketone supplementation on fasting triglyceride concentrations. Serum triglycerides will be measured via standard lipid panel. Mean change from baseline to 12 weeks will be compared across groups.

  10. Change in Serum LDL Cholesterol Concentration (mg/dL)

    Time frame: Baseline to 12 weeks

    To assess the effect of ketogenic diet and exogenous ketone supplementation on fasting low-density lipoprotein (LDL) cholesterol. Serum LDL will be measured via standard lipid panel (Quest Diagnostics). Mean change from baseline to post-intervention will be reported.

  11. Change in Serum HDL Cholesterol Concentration (mg/dL)

    Time frame: Baseline to 12 weeks

    To evaluate changes in fasting high-density lipoprotein (HDL) cholesterol following ketogenic diet or exogenous ketone supplementation. Serum HDL will be analyzed by clinical chemistry methods. Mean change from baseline to 12 weeks will be reported.

Study contacts

Contact information is provided by the study sponsor or research team.

Madison Kackley, PhD

CONTACT

[email protected]

16142479650

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Acronym: (SPARK-Pilot)

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Nov 12, 2025
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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