Actively Recruiting
Feasibility and Efficacy of a Well-Formulated Ketogenic Diet in Delaying Progression of Polycystic Kidney Disease in Patients at Risk for Rapid Progression
Led by Ohio State University · Updated on 2026-05-14
20
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of a well-formulated ketogenic diet on patients with autosomal dominant polycystic kidney disease (ADPKD) who are at high risk for rapid progression to end-stage renal disease (ESRD). This single-center study involves 20 patients and aims to determine how the diet impacts height-adjusted total kidney volume (htTKV), glomerular filtration rate (GFR), and microalbuminuria. Participants are selected based on specific risk factors and prior imaging assessments such as CT or MRI. Participants will follow a ketogenic diet for 52 weeks, designed to achieve blood ketone levels above 0.5 mM by restricting carbohydrates to less than 50 grams per day and consuming approximately 1.5 grams of protein per kilogram of reference weight daily. The majority of calories will come from fats, focusing on monounsaturated and saturated sources from whole foods. The diet will be managed by an investigatory diet team. Monitoring includes daily use of a KetoMojo hand-held glucometer and continuous ketone/glucose monitors replaced biweekly. Blood draws, DEXA scans, and MRI imaging will be performed to assess body composition, kidney function, and cardiac function. Participants will undergo MRI scans, urinary studies, and blood tests at baseline, six months, and the end of the study at 52 weeks. GFR measurements will be taken three times over the course of the study. The continuous ketone and glucose monitoring device will be checked regularly and replaced approximately every two weeks. Researchers will track finger stick beta-hydroxybutyrate and glucose levels as primary outcomes throughout the study. Blood pressure will also be monitored as a secondary outcome. Overall, participant involvement includes regular clinical visits, dietary adherence monitoring, and multiple imaging and laboratory evaluations over one year.
CONDITIONS
Brief Title
Well-Formulated Ketogenic Diet Polycystic Kidney Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-65 years old
- Diagnosis of autosomal dominant polycystic kidney disease (ADPKD) by imaging and/or genetic testing
- Glomerular filtration rate (GFR) of 25 mg/dl or higher
- At risk for rapid progression of ADPKD as defined by Mayo Class 1C-1E or other high-risk features
- No medication changes within the last three months
- Able to comply with the ketogenic diet intervention
- Ability to provide informed consent
You will not qualify if you...
- Current treatment with Tolvaptan
- Diagnosis of diabetes
- Pregnancy
- Contraindications to MRI
- Ketogenic diet within the last three months
- Severe kidney disease with GFR less than 25 mg/dl
- Unable to purchase food required for the diet intervention
- Gastrointestinal disorders interfering with the diet
- Chronic alcohol or drug abuse
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to ~52 weeks
Participants follow a ketogenic diet aiming to achieve blood ketones >0.5 mM with carbohydrate intake under 50 g/day. The diet intervention starts after all baseline testing is complete and includes daily monitoring of ketone and glucose levels using hand-held and continuous monitors. Blood samples and body composition scans are performed at specific intervals throughout the treatment.
Regular visits approximately every 2 weeks for sensor replacement and assessments, plus daily self-monitoring
Trial Site Locations
Total: 1 location
1
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
M
Madison L Kackley, PhD
J
Jeff Volek, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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