Well-Formulated Ketogenic Diet Polycystic Kidney Disease
NCT ID: NCT06325644
Last Updated: 2025-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2024-06-01
2027-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Ketogenic Diet
The KD will follow general principles the investigators have described with the aim to achieve blood ketones \>0.5 mM, which will require most participants to consume \<50 g/day carbohydrate and \~1.5 g/kg reference weight protein. Fat will comprise the remaining calories with an emphasis on monounsaturated and saturated sources from whole foods.
Ketogenic Diet
The diet intervention will start after all baseline testing is complete
Ketone/Glucose Monitoring
KetoMojo hand-held glucometer will be used daily to monitor dietary intervention adherence.
CGM/CKM
Continuous Ketone/Glucose Monitor will be applied at the start of Test Day 1. The sensor will be checked by the study team at each test day and will be removed and replaced by a fresh sensor at \~2- week intervals during the study. The sensor will be removed at the end of the final test day.
Blood Draw
Blood samples will be collected according to the schedule in Figure 1
Body Composition
DEXA Scanning will be done pre-, mid-, and post- intervention.
Change in glomerular filtration rate (mg/mmol) via magnetic resonance imaging (MRI) .
Changes in glomerular filtration rate will be assessed via magnetic resonance imagining conducted by trained professionals. MRI imaging analyses will determine cardiac function. Trained imaging professionals will analyze the images to determine overall change (mg/mmol).
Interventions
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Ketogenic Diet
The diet intervention will start after all baseline testing is complete
Ketone/Glucose Monitoring
KetoMojo hand-held glucometer will be used daily to monitor dietary intervention adherence.
CGM/CKM
Continuous Ketone/Glucose Monitor will be applied at the start of Test Day 1. The sensor will be checked by the study team at each test day and will be removed and replaced by a fresh sensor at \~2- week intervals during the study. The sensor will be removed at the end of the final test day.
Blood Draw
Blood samples will be collected according to the schedule in Figure 1
Body Composition
DEXA Scanning will be done pre-, mid-, and post- intervention.
Change in glomerular filtration rate (mg/mmol) via magnetic resonance imaging (MRI) .
Changes in glomerular filtration rate will be assessed via magnetic resonance imagining conducted by trained professionals. MRI imaging analyses will determine cardiac function. Trained imaging professionals will analyze the images to determine overall change (mg/mmol).
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of ADPKD by imaging and/or genetic testing
* GFR ≥ 25 mg/dl
* Patients at risk for rapid progression of ADPKD: Mayo Class 1C-1E along with any other high risk features including early decline in GFR, hypertension onset ≤ 35 years of age, urologic events ≤ 35 years of age, PKD 1 truncating mutation and PROPKD score of 4 or higher as determined by the treating physician
* No changes of medications within the last three months.
* Able to comply with dietary intervention
* Ability to sign informed consent
Exclusion Criteria
* Diagnosed with diabetes.
* Pregnancy
* Contraindications to MRI
* Ketogenic diet within the last three months
* Severe kidney disease with GFR \< 25 mg/dl
* Unable to purchase food for the diet intervention
* Gastrointestinal disorders that will interfere with diet intervention
* Chronic alcohol or drug abuse
18 Years
65 Years
ALL
No
Sponsors
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Ohio State University
OTHER
Responsible Party
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Locations
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The Ohio State University
Columbus, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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CDMRP-PR212399-G
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2023H0258
Identifier Type: -
Identifier Source: org_study_id
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