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

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.

CT.gov Identifier

NCT07454174

EudraCT Identifier

N/A

CTIS:

N/A

Collaborator

Santa Barbara Nutrients

Study Contact Information

N/A

Recruiting

Study Details

Diseases

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Study Drug

Continuous glucose monitoring

Intermittent fasting

Nutritional counseling

Ren-Nu and KetoCitra

Genes

PKD1

GANAB

Study Dates

Feb 2026 - Feb 2027

Sex

Ignored

Age

18+ years

Inclusion and Exclusion Criteria

Inclusion Criteria:

* 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 Criteria:

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.

Protocol 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.

Study Locations

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