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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07454174
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