Effects of Whole Food, Plant-Based Nutrition on Chronic Kidney Disease With Proteinuria

University of Rochester3 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Kidney Disease Stage 3B Chronic Kidney Disease, Stage 4 Proteinuria

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age greater than 18 years * Subjects with CKD 3b and 4 (as determined by an estimated glomerular filtration rate of ≥ 15 ml/min but ≤ 45 ml/min for at least three months) * Subjects with proteinuria documented at least twice with the most recent test within the last 6 months as determined by: * Urine albumin excretion rate of \> 300 mg/day or urine albumin to creatinine ratio of \> 300 mg/g of creatinine * Urine protein excretion rate of \> 500 mg/day or urine protein to creatinine ratio of \> 0.5 g/g of creatinine * If using angiotensin converting enzyme inhibitor, angiotensin receptor blockers and/or aldosterone antagonists, on a stable dose of for greater than one month * Fluent in English language * Able and willing to comply with the testing and group education schedules * Able and willing to comply with a whole-food, plant-based diet * Able and willing to give informed consent Exclusion Criteria: * Any kidney disease requiring immunosuppressive therapy * Pregnancy or intent to become pregnant in the next 12 months * Life expectancy \< 12 months * History of solid organ transplant or anticipated solid organ transplant in next 12 months * History of hyperkalemia: Two potassium measurements \> 5.1 Meq/L within the last three months, or history of any intervention for hyperkalemia in the last 6 months * Subjects with malabsorptive syndromes * Subjects with history of bariatric surgery or planned bariatric surgery in the next 12 months * Subjects on warfarin * Subjects with current eating disorders * Subjects with tobacco or illicit substance use * Subjects with alcohol use of \> 7 drinks per week * Allergy or intolerance of a plant-based or plant-derived food (gluten, soy, etc.) * Following a vegan diet in the six months prior to consent * Major surgery within 60 days prior to consent

Outcomes

Primary Outcomes

Change in systolic and diastolic blood pressure from baseline

Time frame: 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)

Change in proteinuria from baseline

Urine total protein:creatinine ratio

Time frame: 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)

Change in GFR from baseline

Serum creatinine (renal function panel) and Cystatin C

Time frame: 1, 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)

Secondary Outcomes

Weight changes from baseline

Time frame: 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)

BMI changes from baseline

Time frame: 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)

Waist circumference changes from baseline

Time frame: 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)

8-point bioelectrical impedance analysis changes from baseline

Body composition assessment

Time frame: 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)

Hemoglobin A1c changes from baseline

Diabetic control

Time frame: 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)

KDQOL-36 changes from baseline

Scoring of this questionnaire consists of 5 scales (symptoms/problem list, effects of kidney disease, burden of kidney disease, SF-12 physical composite, and SF-12 mental composite). The lowest possible score for each scale is 0, indicating the worst outcome, and the best possible score is 100, indicating the best possible outcome.

Time frame: 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)

Serum potassium changes from baseline

Time frame: 1, 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)

Serum phosphorus changes from baseline

Time frame: 1, 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)

Serum albumin changes from baseline

Time frame: 1, 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)

Blood glucose level changes from baseline

Fasting serum levels from all subjects; additionally, whole blood levels measured by glucometer in subjects with comorbid type 1 or type 2 diabetes mellitus

Time frame: 1, 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)

Total cholesterol, HDL, LDL, and non-HDL cholesterol level changes from baseline

Fasting lipid panel

Time frame: 1, 4, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)

Serum magnesium changes from baseline

Time frame: 1, 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)

Parathyroid hormone (PTH) changes from baseline

Time frame: 12 weeks (RCT); 3 and 9 months on intervention diet (all subjects)

25-hydroxycholecalciferol changes from baseline

Time frame: 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)

Fibroblast growth factor-23 changes from baseline

Time frame: 12 weeks (RCT); 3 and 9 months on intervention diet (all subjects)

High sensitivity CRP changes from baseline

Time frame: 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)

CBC with differential changes from baseline

Time frame: 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)

Changes in nutrient intakes from baseline based on 3 day food diaries

Assess baseline compared to intervention diet and assess compliance of intervention diet over study duration

Time frame: 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)

Changes in urinary indicators of dietary intake from baseline

24 hour urine collection, urinary oxidation (urinary 8-isoprostane)

Time frame: 12 weeks (RCT); 3 and 9 months on intervention diet (all subjects)

Effects of Whole Food, Plant-Based Nutrition on Chronic Kidney Disease With Proteinuria

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes