NCT07454174 · Richard Fatica
Metabolic Impacts of Ren-Nu: A Dietary Program for Polycystic Kidney Disease
(PKD-KETO)
What this study is about
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.
View original scientific description
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.
Interventions
DIETARY_SUPPLEMENT
Ren-Nu and KetoCitra
This is a structured, nutritionist monitored program supplemented with a nutritional food product, while monitoring metabolic parameters
Primary outcome measures
Change in Serum Renal Function
Time frame: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu
Change from baseline of renal function assessment as measured by creatinine based estimated glomerular filtration rate.
Change in Serum Hepatic Function Biomarkers
Time frame: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu
Change from baseline of serum liver panel biomarkers to track safety signals. Biomarkers include: AST (U/L), ALT (U/L), and LDH (U/L). Measured via standard clinical laboratory assays.
Change in Glycemic Control
Time frame: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu
Change from baseline of glycemic control as measured by aggregate of Hgb A1c and Homeostatic model assessment of insulin resistance (HOMA-IR).
Change in Systemic Inflammation Markers
Time frame: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu
Change from baseline of inflammatory biomarkers as an aggregate using: serum C-reactive protein \[(CRP) mg/dL\] and homocysteine (umol/L). Measured via standard clinical laboratory assays.
Change in Serum Measures of Lipids
Time frame: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu
Change from baseline of of lipids using fasting serum lipid panel to track cholesterol and fat levels. This includes: total cholesterol (mg/dL), HDL cholesterol (mg/dL), LDL cholesterol (mg/dL), and triglycerides (mg/dL).
Change in 24-Hour Urine Collection to track Lithogenic Risk
Time frame: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu
Change from baseline of 24-hour urine analytes in aggregate to assess lithogenic risk. The analytes will include calcium (mg/day), creatinine (mg/day), citrate (mg/day), oxalate (mg/day), uric acid (mg/day), sodium (mmol/day), chloride (mmol/day), magnesium (mg/day), ammonium (mmol/day), sulfate (mmol/day), phosphorus (mg/day), urea nitrogen (g/day), and urine pH. Measured via standard clinical laboratory assays.
Change in Glycemic Variability via a Continuous Glucose Monitor (CGM)
Time frame: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu
Change from baseline in glycemic variability includes mean glucose (mg/dL) measured over a period of time and compared to before and at the end of the Ren-Nu program. This will be measured using the FreeStyle Libre 3 System.
Change in Anthropometric Measures
Time frame: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu
Change from baseline in body weight (kg) and body mass index (kg/m²), calculated from measured height and weight using standardized clinic procedures.
Change in Blood Pressure
Time frame: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu
Change from baseline in systolic and diastolic blood pressure. Seated blood pressure (mmHg) is taken throughout the 4 week orientation period and the 12 week nutritional dietary program. This is measured using a calibrated automated blood pressure machine after 5 minutes of rest.
Change in Serum Fatty Acid
Time frame: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu
Change from baseline of serum free fatty acid (FFA, mmol/L).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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.
Where
- Cleveland, Ohio
Collaborators
Santa Barbara Nutrients
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 6, 2026 · Source of record for eligibility and locations