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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to ~ 52 weeks

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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