Keto-Adaptation for PCOS

((SPARK-Pilot) Trial)

Overseen By Madison Kackley, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Ohio State University

Must not be taking: Hormonal contraception

Disqualifiers: Low-carb diet, Type 1 diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether different methods to achieve ketosis can help women with Polycystic Ovary Syndrome (PCOS) improve their reproductive and metabolic health. Participants will either follow a ketogenic diet or consume an exogenous ketone supplement while maintaining a mixed diet. The study aims to determine if these strategies can restore regular ovulation, improve hormone balance, and enhance overall well-being. Women diagnosed with PCOS who experience symptoms like irregular periods or signs of high male hormones might be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore innovative approaches to managing PCOS symptoms.

Do I need to stop my current medications for the trial?

No, you don't need to stop your current medications. The trial requires you to maintain your current medication habits throughout the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that a ketogenic diet is generally safe and well-tolerated for women with PCOS. Studies have found that this diet can improve hormone levels, aid in weight loss, and enhance overall health without causing major side effects. For instance, one study reported that women on a ketogenic diet experienced better reproductive hormone levels and metabolic health without significant issues.

Regarding ketone supplements, research suggests they are also safe and generally well-tolerated. Studies have shown they help with insulin resistance and other health markers in women with PCOS. No serious side effects have been reported, indicating that the supplements are safe to use.

In summary, both the ketogenic diet and ketone supplements have been studied and found to be safe for women with PCOS, showing positive effects with few reported problems. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for PCOS because they explore the potential benefits of nutritional ketosis without the typical dietary restrictions. The ketogenic diet arm focuses on achieving ketosis through a low-carb, high-fat diet, which may directly impact insulin resistance and hormone balance. The exciting twist in the second arm is introducing an exogenous ketone supplement that raises ketone levels without cutting carbs, offering a novel approach to achieving ketosis. These strategies differ from traditional treatments like hormonal therapies or insulin sensitizers, aiming for a more natural metabolic shift to manage PCOS symptoms.

What evidence suggests that this trial's treatments could be effective for PCOS?

Research has shown that a ketogenic diet, which participants in one arm of this trial will follow, might help women with PCOS by balancing hormones and increasing pregnancy chances. This diet can positively affect hormone levels, weight, and metabolism, which are often concerns for those with PCOS.

In another arm of this trial, participants will follow a mixed diet while consuming ketone supplements. These supplements have shown promise in quickly lowering levels of male hormones and blood sugar, potentially alleviating symptoms related to insulin resistance. This may help women with PCOS regain regular menstrual cycles.

This trial studies both the ketogenic diet and ketone supplements for their potential to manage PCOS symptoms and improve reproductive health. ^{1 2 3 4 6}

Who Is on the Research Team?

Madison Kackley, PhD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

This trial is for women with Polycystic Ovary Syndrome (PCOS) who are interested in exploring dietary approaches to improve their reproductive and metabolic health. Participants should be willing to follow a strict diet or take supplements as assigned, and may have the option of undergoing MRI scans.

Inclusion Criteria

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

Body mass index (BMI) ≥18 kg/m²

Access to a smartphone, computer, or tablet for digital tracking and study communication

Exclusion Criteria

Pregnancy or breastfeeding

Active eating disorder or medical condition that could interfere with dietary intervention

Current adherence to a low-carbohydrate diet (<30% of total energy from carbohydrates)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow either a ketogenic diet or a mixed diet with ketone supplements for 12 weeks to assess changes in ovulatory and metabolic outcomes.

12 weeks

Weekly monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exogenous Ketone Supplement
• Ketogenic diet

Trial Overview The SPARK-Pilot study tests two methods of achieving ketosis: one group will follow a ketogenic diet while another will consume a mixed diet with exogenous ketone supplements. The goal is to see if these strategies can restore regular ovulation, balance hormones, boost metabolism, and enhance overall well-being in PCOS patients.

How Is the Trial Designed?

Group I: Ketogenic Diet (KD) Experimental Treatment 1 Intervention

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.

Group II: Mixed Diet + Exogenous Ketone Supplement Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06155708

Exogenous Ketone Supplementation in Females with ... Exogenous ketone monoester (KME) ingestion has been shown to improves outcomes associated with insulin resistance, endothelial function, and blood pressure ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40393075/

Ketone supplementation acutely lowers androgen and ... This study aimed to determine whether BHB supplementation acutely lowers circulating androgen and glucose levels in women with PCOS.

3. academic.oup.com academic.oup.com/ejendo/article/193/2/L10/8223023

Ketone supplementation acutely lowers androgen and ... Ketone supplementation acutely lowers androgen and glucose levels in women with polycystic ovary syndrome: a randomized clinical trial. Dilara Tekin Uzman ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07227363?term=heart+disease

Symptoms of Polycystic Ovarian Syndrome Ameliorated by ... To evaluate whether ketogenic dietary intervention or exogenous ketone supplementation restores ovulatory function in women with Polycystic ...

5. trialx.com trialx.com/clinical-trials/listings/318213/exogenous-ketone-supplementation-in-females-with-polycystic-ovary-syndrome/?&radius=10&place=Putzu&user_country=Taiwan

Exogenous Ketone Supplementation in Females with ... Exogenous ketone monoester (KME) ingestion has been shown to improves outcomes associated with insulin resistance, endothelial function, and ...

6. withpower.com withpower.com/trial/phase-polycystic-ovary-syndrome-2024-318fb

Ketone Supplementation for Polycystic Ovary Syndrome Research has shown that ketone supplements are safe and generally well-tolerated. One study found that a specific type of ketone supplement, called a ketone ...