RecruitingNot ApplicableNCT07454174

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

Short-Term Metabolic Impacts of Ren-Nu: A Dietary Program for Individuals With Polycystic Kidney Disease


Sponsor

Richard Fatica

Enrollment

20 participants

Start Date

Feb 25, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • Adult (18 years or older)
  • Diagnosis of ADPKD by a physician.
  • Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2 at screening using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
  • Appropriate control of blood pressure (i.e. entry reading <140/90) including the use of BP medications for diagnosis of hypertension.
  • BMI ≥ 25 (accounting for muscle mass)
  • Own an at-home blood pressure monitor (no brand requirements)
  • Able to complete study-related activities (e.g., attend online classes, complete questionnaires, and proper use of medical devices)

Exclusion Criteria33

  • Intolerance or allergy to any of the ingredients in the provided medical food
  • Severe or rare underlying health conditions may cause a safety risk when taking the medical food. Those underlying health conditions will be assessed by the enrolling physician and include but are not limited to:
  • History of hyperkalemia
  • Heart failure
  • Liver cirrhosis
  • Chronic kidney disease stage 4 or greater, or other renal condition that severely impairs bone mineral homeostasis.
  • HIV infection
  • Chronic drug or alcohol abuse
  • Chronic malabsorption syndrome
  • Malignancy (non-melanoma skin cancer exempted)
  • Autoimmune disease
  • Pregnant, planning to be pregnant, or nursing during the course of the study
  • Chronic history of recurrent urinary tract infections (UTI) (≥ 3 UTIs per year)
  • Diagnosis of aneurysm
  • Indigestion due to hypochlorhydria (low stomach acid)
  • Any other condition, that in the opinion of the enrolling physician, makes the subject an unsuitable candidate for the study.
  • Current use of any of the following medications or supplements which could affect safety or compliance with this study:
  • The medical food, KetoCitra®.
  • Urine alkalizing agents such as sodium bicarbonate or potassium citrate
  • Citrate treatments
  • Immunosuppressive treatment
  • Tolvaptan
  • Potassium-sparing diuretics
  • Somatostatin analogs
  • Aluminum-containing supplements or medications such as aluminum antacids (e.g. Maalox) or aluminum-based phosphate binders.
  • SGLT2 inhibitors
  • 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.)
  • Food sensitivities or allergies that are incompatible with the interventional nutrition program.
  • The subject is already adhering to a form of a ketogenic diet or related fasting regimen.
  • Current or past history of disordered eating or feeding behaviors.
  • History of gastric bypass.
  • Active diagnosis of ulcerative colitis, Irritable Bowel Syndrome, Crohn's, or Gallbladder Disease.

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Interventions

DIETARY_SUPPLEMENTRen-Nu and KetoCitra

This is a structured, nutritionist monitored program supplemented with a nutritional food product, while monitoring metabolic parameters


Locations(1)

Cleveland Clinic

Cleveland, Ohio, United States

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NCT07454174


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