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NCT07227363 · ClinicalTrials.gov registry record · NA
Symptoms of Polycystic Ovarian Syndrome Ameliorated by Keto-Adaptation Pilot
A NA study of PCOS (Polycystic Ovary Syndrome), sponsored by Ohio State University.
- Recruiting
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT07227363: Recruiting NA study of PCOS (Polycystic Ovary Syndrome), sponsored by Ohio State University.
NCT07227363 is a NA study of PCOS (Polycystic Ovary Syndrome) that is actively recruiting participants, run by Ohio State University. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07227363, a NA study of PCOS (Polycystic Ovary Syndrome), is actively recruiting participants, sponsored by Ohio State University.
- RECRUITING
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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 c
Conditions Studied
Interventions
- OTHER Ketogenic diet
- DIETARY_SUPPLEMENT Exogenous Ketone Supplement
Study Locations (1)
Ohio
- The Ohio State University - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2025-02-01 |
| Est. Completion | 2026-12 |
| Phase | NA |
What NCT07227363 shows while recruiting
NCT07227363 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 1 condition, with PCOS (Polycystic Ovary Syndrome) appearing as the primary indexed condition, and to 2 interventions - of which Ketogenic diet is the first listed.
NCT07227363 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT07227363 about?
NCT07227363 is a clinical study titled "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). Pa...
What is the current status of trial NCT07227363?
This trial is currently recruiting. It is a NA study. The enrollment target is 40 participants. The study started on 2025-02-01. Estimated completion is 2026-12.
What conditions does trial NCT07227363 study?
This clinical trial studies the following conditions: PCOS (Polycystic Ovary Syndrome).
What interventions are being tested in trial NCT07227363?
The interventions under investigation include: Ketogenic diet (OTHER), Exogenous Ketone Supplement (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT07227363?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07227363 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07227363's enrollment target sits among peer trials
40 1447th of 2000 higher than 465 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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