20 Participants NeededMy employer runs this trial

Ren-Nu + KetoCitra for Polycystic Kidney Disease

(PKD-KETO Trial)

CB
RF
Overseen ByRichard Fatica, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effects of a ketogenic diet called Ren-Nu, combined with a supplement called KetoCitra, on individuals with autosomal dominant polycystic kidney disease, a genetic disorder characterized by cysts on the kidneys. Researchers will provide nutritional counseling and instruct participants on following this specific diet plan. Individuals diagnosed with this kidney condition, who have a BMI of 25 or higher, and can manage their blood pressure at home may be suitable candidates. As an unphased trial, this study offers a unique opportunity to explore innovative dietary approaches for managing kidney disease.

Do I need to stop taking my current medications for the trial?

You may need to stop taking certain medications if they could affect safety or compliance with the study. These include medications like KetoCitra, urine alkalizing agents, and some others. It's best to discuss your current medications with the trial team to see if any changes are needed.

What prior data suggests that this nutritionist-led ketogenic diet and supplement are safe for polycystic kidney disease?

Research has shown that ketogenic diets, such as Ren-Nu and KetoCitra, are generally safe for individuals with autosomal dominant polycystic kidney disease (ADPKD). In studies, 66% of participants experienced common side effects, and 22% reported concerns like high cholesterol. However, 92% found the diet manageable.

Most participants could adhere to the diet and found it easy to follow. The diet has shown promise in slowing kidney disease progression in both humans and animals. Overall, while some side effects may occur, many individuals tolerate the treatment well.12345

Why are researchers excited about this trial?

Unlike the standard of care for polycystic kidney disease, which typically involves managing symptoms with blood pressure medications and sometimes dialysis or kidney transplant, Ren-Nu offers a novel approach. Researchers are excited about these treatments because Ren-Nu, combined with the KetoCitra supplement, leverages a ketogenic diet to potentially slow down kidney cyst growth. This dietary strategy focuses on altering metabolism, which is a fresh angle compared to traditional methods that do not directly target metabolic pathways. By addressing the disease's root causes through nutrition, Ren-Nu could offer a non-invasive, holistic alternative to managing polycystic kidney disease.

What evidence suggests that this trial's treatments could be effective for polycystic kidney disease?

Studies have shown that ketogenic diets can benefit people with polycystic kidney disease (ADPKD). In earlier research, 67% of participants reported improvements in health issues related to ADPKD, and 90% experienced significant weight loss. Another study found that a ketogenic diet slowed kidney growth, which is important because it can mean less damage over time. In animal studies, ketogenic diets also reduced kidney size and improved kidney function. This trial will evaluate the effects of a ketogenic diet, as part of the Ren-Nu program, combined with the KetoCitra supplement, to determine if it might help manage ADPKD symptoms and slow its progression.12367

Who Is on the Research Team?

RF

Richard Fatica, MD

Principal Investigator

The Cleveland Clinic

TW

Thomas Weimbs, PhD

Principal Investigator

Santa Barbara Nutrients

Are You a Good Fit for This Trial?

This trial is for adults (18+) with autosomal dominant polycystic kidney disease, a BMI of 25 or higher, controlled blood pressure, and healthy enough kidneys. Participants must be able to attend online classes and use home devices. People with certain digestive issues, allergies to the study foods, severe health conditions, or who are pregnant cannot join.

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.
See 4 more

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.)
See 7 more

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

Trial Overview

The study tests a nutritionist-led ketogenic diet program called Ren-Nu combined with KetoCitra (a medical food) over 16 weeks in people with polycystic kidney disease. The goal is to see how this dietary approach affects metabolism and kidney health.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Pilot study on ketogenic diet Ren-Nu and KetoCitra supplement on ADPKDExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Richard Fatica

Lead Sponsor

Santa Barbara Nutrients

Collaborator

Citations

Feasibility and impact of ketogenic dietary interventions in ...

Highlights. •. Ketogenic diets are feasible for patients with polycystic kidney disease (ADPKD). •. Ketogenic diets (KD) reduce body weight ...

Ren.Nu, a Dietary Program for Individuals with Autosomal ...

Results suggested that slowed kidney growth correlated with loss of body fat weight suggesting that the observed effects may involve periods of ketosis.

Ketogenic Diet in ADPKD: Safety & Effects

Among them, 86% reported improved overall health, 67% noted benefits for ADPKD-related issues, and 90% observed significant weight loss. Improvements in blood ...

Real-world outcomes of managing autosomal-dominant ...

This study evaluated real-world outcomes from the Ren-Nu™ program, a remotely administered educational program for individuals with ADPKD that ...

Ketogenic Interventions in Autosomal Dominant Polycystic ...

BHB-treated PKD rats showed notable reductions in kidney size and cystic area compared to controls. BHB treatment also led to improved kidney function and ...

Ren-Nu™ Program and Outcomes

We developed a remote, dietitian-supervised program teaching individuals with ADPKD to adopt a plant-focused ketogenic diet, avoid renal stressors, and track ...

Ketogenic dietary interventions for autosomal-dominant ...

The evidence on KDIs for ADPKD is still limited. However, KDIs, particularly caloric-restriction diets, appear promising tools for managing ADPKD. Current human ...