Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
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RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: Ketogenic diet for PCOS (Polycystic Ovary Syndrome)

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). you would be randomly assigned to one of two groups: * A ketogenic diet group, following a low-carbohydrate, nutrient-dense meal plan.

Official registry: https://clinicaltrials.gov/study/NCT07227363 · Ohio State University · enrollment listed as 40

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Ketogenic diet, or Exogenous Ketone Supplement. The registry lists allocation as randomized. 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).

They plan to enroll about 40 people at Columbus. Taking part typically means study visits and measurements plus check-ins.

Official title (unrewritten)

Symptoms of Polycystic Ovarian Syndrome Ameliorated by Keto-Adaptation Pilot

Interventions: Ketogenic diet, Exogenous Ketone Supplement

Primary outcome (registry wording): Change in Ovulatory Status

Who it is for (from inclusion criteria)

  • Ages 18 Years to 40 Years
  • Women only
  • 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 (body-mass index (BMI)) ≥18 kg/m²
  • Access to a smartphone, computer, or tablet for digital tracking and study communication

Public study contact (from the registry)

Madison Kackley, PhD

16142479650

Kackley.19@osu.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT07227363 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07227363?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07227363?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary