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

NCT07454174 | Recruiting

• 2 other identifiers: 24-893SBN2504RF
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Keywords

ADPKD; polycystic kidneys; Ren-Nu; KetoCitra; Keto diet

Outcome Measures

Primary Outcomes (10)

• Change in Serum Renal Function

  Change from baseline of renal function assessment as measured by creatinine based estimated glomerular filtration rate.

  Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu

• Change in Serum Hepatic Function Biomarkers

  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.

  Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu

• Change in Glycemic Control

  Change from baseline of glycemic control as measured by aggregate of Hgb A1c and Homeostatic model assessment of insulin resistance (HOMA-IR).

  Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu

• Change in Systemic Inflammation Markers

  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.

  Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu

• Change in Serum Measures of Lipids

  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).

  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

  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.

  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)

  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.

  Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu

• Change in Anthropometric Measures

  Change from baseline in body weight (kg) and body mass index (kg/m²), calculated from measured height and weight using standardized clinic procedures.

  Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu

• Change in Blood Pressure

  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.

  Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu

• Change in Serum Fatty Acid

  Change from baseline of serum free fatty acid (FFA, mmol/L).

  Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu

Secondary Outcomes (5)

• Change in health-related quality of life as assessed by the Quality of Life: Short-Form Health Survey 12 (SF-12v2)

  Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu

• Change in self reported mental and physical health outcomes

  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

  Visit 3 (Day 120) after Ren-Nu

• Assessment of dietary intervention tolerability following the structured nutrition education program

  Visit 3 (Day 120) after Ren-Nu

• Assessment of dietary intervention feasibility following the structured nutrition education program

  Visit 3 (Day 120) after Ren-Nu

Study Arms (1)

Pilot study on ketogenic diet Ren-Nu and KetoCitra supplement on ADPKD

EXPERIMENTAL

Nutritional counseling and instruction in a ketogenic diet and nutritional food supplement

Dietary Supplement: Ren-Nu and KetoCitra

Interventions

Ren-Nu and KetoCitra DIETARY_SUPPLEMENT

This is a structured, nutritionist monitored program supplemented with a nutritional food product, while monitoring metabolic parameters

Also known as: Continuous glucose monitoring, intermittent fasting, Nutritional counseling

Pilot study on ketogenic diet Ren-Nu and KetoCitra supplement on ADPKD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Richard Fatica: lead
• Santa Barbara Nutrients: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant; Polycystic Kidney Diseases

Interventions

Continuous Glucose Monitoring; Nutrition Assessment

Condition Hierarchy (Ancestors)

Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Richard Fatica, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Thomas Weimbs, PhD

  Santa Barbara Nutrients

  STUDY DIRECTOR

Central Study Contacts

Chloe Booth

CONTACT

216-444-5053; boothc2@ccf.org

Richard Fatica, MD

CONTACT

216-445-9953; faticar@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice Chairman Department of Kidney Medicine

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: March 6, 2026
• Study Start: February 25, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

US (1)