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New treatment option for PCOS (Polycystic Ovary Syndrome)
Official title Symptoms of Polycystic Ovarian Syndrome Ameliorated by Keto-Adaptation Pilot
ClinicalTrials.gov ID: NCT07227363
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40, women only
You may be able to join if
- 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...
- Willingness and ability to comply with all study procedures, including fasting (\>10 hours; water only), avoidance of alcohol (\>24 hours), and...
- Willing to maintain current diet, exercise, medication, and supplement habits throughout the study.
- Body mass index (BMI) ≥18 kg/m².
You likely can't join if
- 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.
See the full eligibility 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.