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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
This is a structured, nutritionist monitored program supplemented with a nutritional food product, while monitoring metabolic parameters
Cleveland Clinic
Cleveland, Ohio, United States
RECRUITINGChange in Serum Renal Function
Change from baseline of renal function assessment as measured by creatinine based estimated glomerular filtration rate.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
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
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.
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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)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu
Change in health-related quality of life as assessed by the Quality of Life: Short-Form Health Survey 12 (SF-12v2)
Participants will complete the Quality of Life: Short-Form Health Survey 12 (SF-12v2) on Day 0 and Day 120. Scores are standardized by mean. A higher score indicates a better-than-average health-related quality of life, while a lower score suggests a below-average health-related quality of life.
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
This is reported as a change in participant reported mental health status measured via both the Quality of Life: Short-Form Health Survey 12 (SF-12v2) and the study-developed Ren-Nu Outcomes survey. The outcomes survey assesses topics such as final weight (kg), final blood pressure (mmHg), current PKD related symptoms, and changes to medications/supplements.
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
Self reported participant nutrition knowledge of the nutritional program at the end of the program. This is a study-developed questionnaire and these questions are multiple choice with a low score reflecting lower nutritional knowledge of the dietary program and a high score reflecting higher nutritional knowledge of the dietary program.
Time frame: Visit 3 (Day 120) after Ren-Nu
Assessment of dietary intervention tolerability following the structured nutrition education program
Self reported participant tolerability of the nutritional program at the end of the program. This is a study-developed questionnaire and questions are multiple choice with a low score reflecting a lower tolerability to the dietary program and a high score reflecting higher satisfaction with the program.
Time frame: Visit 3 (Day 120) after Ren-Nu
Assessment of dietary intervention feasibility following the structured nutrition education program
Self reported participant feasibility of the nutritional program at the end of the program. This is a study-developed questionnaire and questions are multiple choice with a low score reflecting lower feasibility of the dietary program and a high score reflecting higher feasibility of the dietary program.
Time frame: Visit 3 (Day 120) after Ren-Nu