No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
Richard Fatica · Other
Who this trial is looking for
This trial is looking for adults with polycystic kidney disease who are interested in trying a special ketogenic diet guided by a nutritionist. Participants will follow the diet for 16 weeks and take a specific medical food supplement.
Are You a Good Fit for This Trial?
Must not be takingKetoCitraFluid alkalizing agentsSGLT2 inhibitorsTolvaptanPotassium-sparing diureticsImmunosuppressants
Rules you outHeart failureChronic kidney disease stage 4 or greaterAutoimmune diseaseMalignancy
You may be able to join if
I am 18 years or older
I have been diagnosed with polycystic kidney disease
My kidney function is adequate with an eGFR of 30 or more
I have controlled blood pressure below 140/90
My BMI is 25 or higher
I have a blood pressure monitor at home
I can participate in online classes and complete questionnaires
You may not be able to join if
I have allergies to any ingredients in the medical food
I have a history of severe health conditions like heart failure or hyperkalemia
I am pregnant, planning to become pregnant, or nursing
I have a current use of certain medications like Immunosuppressants
I have had disordered eating habits in the past
I have active gastrointestinal diseases like Crohn's or IBS
I have a history of gastric bypass surgery
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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Eligibility 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. en…
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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