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Recruiting NCT07454174

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

No phase Interventional Autosomal Dominant Polycystic Kidney Disease (ADPKD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ren-Nu and KetoCitra.
Who it may be relevant to
Registry conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

The goal of the Ren-Nu program aims to improve the metabolic health of ADPKD patients by implementing a plant-focused, kidney-safe, ketogenic diet supported by medical food KetoCitra®. It is a dietitian-led, online group program focused on ketogenic metabolic therapy with rolling recruitment .

For 12 weeks, participants will be remotely directed through the Ren-Nu program by an experienced renal dietitian where they will learn to implement diet and lifestyle changes by completing weekly web-based classes on nutrition principles and food preparation. A continuous glucose monitor (CGM) will be provided for use during the study. Additionally, they will use a smartphone application to track nutrient intake, self-monitor biomarkers, implement mindfulness practice, and participate in facilitated discussions to build community support. Each participant will meet remotely with the renal dietitian and complete laboratory safety monitoring throughout the program to tailor dietary recommendations for optimal compliance. The study will involve visits to the research institution, histories, physical examinations and laboratory work.

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 in Serum Hepatic Function Biomarkers [Time frame: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu]
  • Change in Glycemic Control [Time frame: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu]
  • Change in Systemic Inflammation Markers [Time frame: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu]
  • Change in Serum Measures of Lipids [Time frame: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu]
  • 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 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 in Anthropometric Measures [Time frame: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu]
  • Change in Blood Pressure [Time frame: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu]
  • Change in Serum Fatty Acid [Time frame: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu]
Secondary outcome measures (5)
  • Change in health-related quality of life as assessed by the Quality of Life: Short-Form Health Survey 12 (SF-12v2) [Time frame: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu]
  • Change in self reported mental and physical health outcomes [Time frame: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu]
  • Assessment of nutrition knowledge following the structured nutrition education program [Time frame: Visit 3 (Day 120) after Ren-Nu]
  • Assessment of dietary intervention tolerability following the structured nutrition education program [Time frame: Visit 3 (Day 120) after Ren-Nu]
  • Assessment of dietary intervention feasibility following the structured nutrition education program [Time frame: Visit 3 (Day 120) after Ren-Nu]

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. 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Cleveland Clinic — Cleveland

Identifiers

NCT: NCT07454174 · 24-893 · SBN2504RF

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗