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

Change in Serum Renal Function

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

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.

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).

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.

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.

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.

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.

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.