Well-Formulated Ketogenic Diet Polycystic Kidney Disease

NCT06325644 | Recruiting

• 2 other identifiers: 2023H0258CDMRP-PR212399-G
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Finger Stick Beta-Hydroxybutyrate

  changes in fasting ketone levels.

  Up to ~ 52 Weeks

• Finger Stick Glucose

  changes in fasting glucose levels.

  Up to ~ 52 Weeks

Secondary Outcomes (1)

• Blood Pressure

  Time Frame: Up to ~ 12 Weeks

Study Arms (1)

Ketogenic Diet

EXPERIMENTAL

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.

Other: Ketogenic Diet; Biological: Ketone/Glucose Monitoring; Biological: CGM/CKM; Biological: Blood Draw; Other: Body Composition; Other: Change in glomerular filtration rate (mg/mmol) via magnetic resonance imaging (MRI) .

Interventions

Ketogenic Diet OTHER

The diet intervention will start after all baseline testing is complete

Ketogenic Diet

Ketone/Glucose Monitoring BIOLOGICAL

KetoMojo hand-held glucometer will be used daily to monitor dietary intervention adherence.

Ketogenic Diet

CGM/CKM BIOLOGICAL

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.

Ketogenic Diet

Blood Draw BIOLOGICAL

Blood samples will be collected according to the schedule in Figure 1

Ketogenic Diet

Body Composition OTHER

DEXA Scanning will be done pre-, mid-, and post- intervention.

Ketogenic Diet

Change in glomerular filtration rate (mg/mmol) via magnetic resonance imaging (MRI) . OTHER

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).

Ketogenic Diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Conditions

Polycystic Kidney Diseases

Interventions

Diet, Ketogenic; Ketones; Blood Specimen Collection; Body Composition; Glomerular Filtration Rate; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Organic Chemicals; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Biochemical Phenomena; Chemical Phenomena; Metabolism; Body Constitution; Kidney Function Tests; Diagnostic Techniques, Urological; Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Spectrum Analysis; Chemistry Techniques, Analytical

Central Study Contacts

Madison L Kackley, PhD

CONTACT

6142479650; kackley.19@osu.edu

Jeff Volek, PhD

CONTACT

6142926488; volek.1@osu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 22, 2024
• Study Start: June 1, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)