Home › NCT06325644

Well-Formulated Ketogenic Diet Polycystic Kidney Disease

Feasibility and Efficacy of a Well-Formulated Ketogenic Diet in Delaying Progression of Polycystic Kidney Disease in Patients at Risk for Rapid Progression

Who can join

Ages 18 to 65 · All sexes

Inclusion Criteria:

* Age 18-65 years old
* 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:

* Patients currently being treated with Tolvaptan
* 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

About the study

This is a prospective study to determine ketogenic diet effect on htTKV, GFR, microalbuminuria. This is a single-center study of 20 patients with ADPKD and deemed high risk for progression to ESRD. This determined by combination of features of ADPKD and htTKV as assessed by prior computed tomography (CT) or MRI. Patients will be recruited from the Polycystic Kidney Disease (PKD) Clinic at Ohio State University Wexner Medical Center. Enrolled patients will have MRI for htTKV, urinary studies, blood tests at baseline, 6 months, and 52 weeks. Blood for GFR will be assessed three times over the course of the study including baseline, 6 months, and 1 year. Participants will follow ketogenic diet for 52 weeks. Investigatory diet team will manage the ketogenic diet.

What is being tested

• Ketogenic Diet (other)
• Ketone/Glucose Monitoring (biological)
• CGM/CKM (biological)
• Blood Draw (biological)
• Body Composition (other)
• Change in glomerular filtration rate (mg/mmol) via magnetic resonance imaging (MRI) . (other)

Sponsor: Ohio State University · Participants: 20 · Started: Jun 1, 2024

Contact the study team

• Madison L Kackley, PhD · Phone: 6142479650
• Jeff Volek, PhD · Phone: 6142926488

Official record on ClinicalTrials.gov — NCT06325644

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.