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Nutritional Therapy

Ketogenic Diet for Kidney Disease

N/A
Recruiting
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of ADPKD by imaging and/or genetic testing
Age 18-65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to ~ 52 weeks
Awards & highlights

Summary

This trial will study how a ketogenic diet affects kidney function in patients with a certain type of kidney disease. They will recruit 20 patients with high-risk kidney disease and assess their kidney function using imaging scans

Who is the study for?
This trial is for adults aged 18-65 with Polycystic Kidney Disease at high risk of kidney failure, specifically those classified as Mayo Class 1C-1E. Participants should be able to follow a ketogenic diet and have stable medication use for the last three months. They must also have a GFR (a measure of kidney function) of at least 25 mg/dl.
What is being tested?
The study tests how a well-formulated ketogenic diet affects kidney size, function, and protein leakage in urine over one year. It involves regular blood draws, monitoring ketone/glucose levels using CGM/CKM devices, MRI scans to assess changes in kidney volume and filtration rate, and body composition analysis.
What are the potential side effects?
Potential side effects may include nutrient deficiencies or imbalances due to dietary restrictions, gastrointestinal discomfort such as constipation or diarrhea from the ketogenic diet, possible alterations in blood lipid levels, and hypoglycemia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with ADPKD through imaging or genetic tests.
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I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to ~ 52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~ 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Finger Stick Beta-Hydroxybutyrate
Finger Stick Glucose
Secondary study objectives
Blood Pressure

Trial Design

1Treatment groups
Experimental Treatment
Group I: Ketogenic DietExperimental Treatment6 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketone/Glucose Monitoring
2018
N/A
~40
Blood Draw
2014
Completed Phase 4
~2350

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor
859 Previous Clinical Trials
642,745 Total Patients Enrolled
~13 spots leftby Apr 2026
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