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

RecruitingNAAges 18 Years - anyAllRichard Fatica
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Ren-Nu and KetoCitra
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Where

1 site
Cleveland Clinic
Cleveland, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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