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

Not Applicable

Terminated

• Conditions: Proteinuria; Chronic Kidney Disease Stage 3B; Chronic Kidney Disease, Stage 4
• Interventions: Other: whole food, plant-based diet

• Registration Number: NCT04171778
• Lead Sponsor: University of Rochester

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-29
• Study First Submitted QC: 2019-11-18
• Study First Posted: 2019-11-21
• Study Start: 2019-12-05
• Primary Completion: 2022-03-28
• Study Completion: 2022-03-28
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-02
• Last Update Posted: 2022-05-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	whole food, plant-based diet	Subjects in this arm will immediately begin a whole-food, plant-based nutrition program consisting of weekly educational group meetings and prepared meals delivered to the subjects' homes for the first 12 weeks followed by monthly educational group meetings for an additional 6 months.
Wait List Control	whole food, plant-based diet	Subjects in this arm will continue their usual care as directed by their nephrologist for 12 weeks before starting the same whole-food, plant-based nutrition program as the intervention arm subjects.

Primary Outcome Measures

Name	Time	Method
Change in systolic and diastolic blood pressure from baseline	4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
Change in proteinuria from baseline	4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)	Urine total protein:creatinine ratio
Change in GFR from baseline	1, 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)	Serum creatinine (renal function panel) and Cystatin C

Secondary Outcome Measures

Name	Time	Method
Weight changes from baseline	4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
Waist circumference changes from baseline	4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
8-point bioelectrical impedance analysis changes from baseline	12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)	Body composition assessment
Serum phosphorus changes from baseline	1, 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
BMI changes from baseline	4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
Hemoglobin A1c changes from baseline	4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)	Diabetic control
KDQOL-36 changes from baseline	12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)	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.
Total cholesterol, HDL, LDL, and non-HDL cholesterol level changes from baseline	1, 4, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)	Fasting lipid panel
Parathyroid hormone (PTH) changes from baseline	12 weeks (RCT); 3 and 9 months on intervention diet (all subjects)
Changes in nutrient intakes from baseline based on 3 day food diaries	12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)	Assess baseline compared to intervention diet and assess compliance of intervention diet over study duration
Serum potassium changes from baseline	1, 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
Serum albumin changes from baseline	1, 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
Blood glucose level changes from baseline	1, 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)	Fasting serum levels from all subjects; additionally, whole blood levels measured by glucometer in subjects with comorbid type 1 or type 2 diabetes mellitus
25-hydroxycholecalciferol changes from baseline	12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
Serum magnesium changes from baseline	1, 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
CBC with differential changes from baseline	12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
Fibroblast growth factor-23 changes from baseline	12 weeks (RCT); 3 and 9 months on intervention diet (all subjects)
High sensitivity CRP changes from baseline	12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
Changes in urinary indicators of dietary intake from baseline	12 weeks (RCT); 3 and 9 months on intervention diet (all subjects)	24 hour urine collection, urinary oxidation (urinary 8-isoprostane)

Trial Locations

Locations (1)

Highland Hospital (University of Rochester); 🇺🇸 Rochester, New York, United States