Ren-Nu + KetoCitra for Polycystic Kidney Disease

(PKD-KETO Trial)

Overseen By Richard Fatica, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Richard Fatica

Must not be taking: KetoCitra, Urine alkalizing, Immunosuppressives, SGLT2 inhibitors

Disqualifiers: Hyperkalemia, Heart failure, Liver cirrhosis, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a 16 week pilot study of the impact of a nutritionist led ketogenic diet (Ren-Nu) supplemented with the medical food KetoCitra on autosomal dominant polycystic kidney disease.

Who Is on the Research Team?

Richard Fatica, MD

Principal Investigator

The Cleveland Clinic

Thomas Weimbs, PhD

Principal Investigator

Santa Barbara Nutrients

Are You a Good Fit for This Trial?

Inclusion Criteria

Able to complete study-related activities (e.g., attend online classes, complete questionnaires, and proper use of medical devices)

I am 18 years old or older.

My blood pressure is controlled and below 140/90, with or without medication.

Exclusion Criteria

Intolerance or allergy to any of the ingredients in the provided medical food

Participation in another therapeutic intervention trial

Following a highly specialized or extreme diet that is incompatible with the interventional nutrition program (e.g. carnivore, very high protein diet for elite athletes, etc.)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Orientation

Participants undergo a 4-week orientation period to prepare for the dietary program

4 weeks

Treatment

Participants follow a 12-week Ren-Nu ketogenic diet program with nutritional counseling and use of a continuous glucose monitor

12 weeks

Weekly remote meetings with dietitian

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ren-Nu

How Is the Trial Designed?

Group I: Pilot study on ketogenic diet Ren-Nu and KetoCitra supplement on ADPKD Experimental Treatment 1 Intervention

Nutritional counseling and instruction in a ketogenic diet and nutritional food supplement

Who Is Running the Clinical Trial?

Richard Fatica

Lead Sponsor

Santa Barbara Nutrients

Collaborator