Stopped: Substantially redesigning study protocol and opening a new study in the future.
This study will test the hypothesis that lifestyle intervention consisting of a whole food, plant-based (WFPB) diet and group education will favorably impact outcomes germane to individuals with chronic kidney disease (CKD) stage 3b and 4, including blood pressure control, amount of proteinuria (protein in the urine), and preservation of glomerular filtration rate (GFR). In addition, this study will assess weight and body composition, diabetic control in subjects with diabetes as well as CKD, and quality of life. Safety of a WFPB diet in subjects with CKD will be tested with respect to the development of elevated serum potassium and phosphorus, hypoalbuminemia (low blood protein), hypotension (low blood pressure), and hypoglycemia (low blood sugar). An exploratory aim is to test the effects of a WFPB diet on the microbiome of subjects by collecting and analyzing stool samples.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Change in systolic and diastolic blood pressure from baseline
Timeframe: 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
Change in proteinuria from baseline
Timeframe: 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
Change in GFR from baseline
Timeframe: 1, 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)