Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07454174

Metabolic Impacts of Ren-Nu: A Dietary Program for Polycystic Kidney Disease

Led by Richard Fatica · Updated on 2026-03-06

20

Participants Needed

1

Research Sites

100 weeks

Total Duration

On this page

Sponsors

R

Richard Fatica

Lead Sponsor

S

Santa Barbara Nutrients

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Metabolic Impacts of Ren-Nu: A Dietary Program for Polycystic Kidney Disease

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult (18 years or older)
  • Diagnosis of ADPKD by a physician
  • Estimated glomerular filtration rate (eGFR) 6 30 mL/min/1.73 m2 at screening using CKD-EPI equation
  • Controlled blood pressure (entry reading <140/90) including use of blood pressure medications
  • Body mass index (BMI) 6 25 (accounting for muscle mass)
  • Own an at-home blood pressure monitor
  • Able to complete study activities such as attending online classes, completing questionnaires, and using medical devices properly
Not Eligible

You will not qualify if you...

  • Allergy or intolerance to ingredients in the provided medical food
  • Severe or rare health conditions that pose safety risks, including history of hyperkalemia, heart failure, liver cirrhosis, chronic kidney disease stage 4 or greater, HIV infection, chronic drug or alcohol abuse, chronic malabsorption syndrome, malignancy (except non-melanoma skin cancer), autoimmune disease
  • Pregnant, planning to be pregnant, or nursing during the study
  • Chronic recurrent urinary tract infections (3 or more per year)
  • Diagnosis of aneurysm
  • Indigestion due to low stomach acid (hypochlorhydria)
  • Any condition deemed unsuitable for study participation by the enrolling physician
  • Current use of KetoCitra or similar medical food
  • Use of urine alkalizing agents such as sodium bicarbonate or potassium citrate, citrate treatments, immunosuppressive treatments, Tolvaptan, potassium-sparing diuretics, somatostatin analogs, aluminum-containing supplements or medications, or SGLT2 inhibitors
  • Participation in another therapeutic intervention trial
  • Following a highly specialized or extreme diet incompatible with the study program
  • Food sensitivities or allergies incompatible with the study diet
  • Already following a ketogenic diet or related fasting regimen
  • Current or past disordered eating or feeding behaviors
  • History of gastric bypass surgery
  • Active diagnosis of ulcerative colitis, irritable bowel syndrome, Crohn's disease, or gallbladder disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Actively Recruiting

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Research Team

C

Chloe Booth

CONTACT

R

Richard Fatica, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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