Recruiting

Ketogenic Diet

Sponsor:

Ohio State University

Code:

NCT06325644

Conditions

Polycystic Kidney Disease

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Ketogenic Diet

Ketone/Glucose Monitoring

CGM/CKM

Blood Draw

Body Composition

Study Details

Brief summary:

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.

Conditions

Polycystic Kidney Disease

Study ID

NCT06325644

Start date

Jun 1, 2024

Status verified date

Sep, 2025

Completion date

Apr 1, 2027

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

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).

Primary outcome measure

  • Finger Stick Beta-Hydroxybutyrate [ Time Frame: Up to ~ 52 Weeks ]
  • Finger Stick Glucose [ Time Frame: Up to ~ 52 Weeks ]

Central Contacts and Locations

Central contacts

Madison L Kackley, PhD

6142479650kackley.19@osu.edu

Jeff Volek, PhD

6142926488volek.1@osu.edu

Locations

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Madison L Kackley, PhD

740-817-1622kackley.19@osu.edu

Jeff Volek, PhD

6146881701volek.1@osu.edu

More Information

Sponsor

Ohio State University

Last update posted

May 14, 2026

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-05-14.