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

Effects of a Whole Food, Plant-Based Nutrition Program on Subjects With Chronic Kidney Disease and Proteinuria

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 Overview

• Status: Terminated
• Conditions: Proteinuria; Chronic Kidney Disease Stage 3B; Chronic Kidney Disease, Stage 4
• Intervention / Treatment: Other: whole food, plant-based diet

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14620
      • Highland Hospital (University of Rochester)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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.	Other: whole food, plant-based diet; The study diet is whole food, plant based defined as containing no animal products or refined grains or added oils, minimal use of any sweeteners, and, for the purposes of this study, on average containing no more than 15% calories from fat.
Other: Wait List Control; 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.	Other: whole food, plant-based diet; The study diet is whole food, plant based defined as containing no animal products or refined grains or added oils, minimal use of any sweeteners, and, for the purposes of this study, on average containing no more than 15% calories from fat.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Urine total protein:creatinine ratio	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	1, 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight changes from baseline		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)
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	Body composition assessment	12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
Hemoglobin A1c changes from baseline	Diabetic control	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.	12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
Serum potassium changes from baseline		1, 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
Serum phosphorus 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	Fasting serum levels from all subjects; additionally, whole blood levels measured by glucometer in subjects with comorbid type 1 or type 2 diabetes mellitus	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	1, 4, and 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)
Parathyroid hormone (PTH) changes from baseline		12 weeks (RCT); 3 and 9 months on intervention diet (all subjects)
25-hydroxycholecalciferol 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)
CBC with differential changes from baseline		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	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)	12 weeks (RCT); 3 and 9 months on intervention diet (all subjects)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory stool microbiome evaluation	Changes in microbiome from baseline	12 weeks (RCT)

Collaborators and Investigators

• Sponsor: University of Rochester
• Investigators: Principal Investigator: Erin Campbell, MD, MPH, University of Rochester; Principal Investigator: Scott E Liebman, MD, MPH, University of Rochester

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2019
• Primary Completion (Actual): March 28, 2022
• Study Completion (Actual): March 28, 2022

Study Registration Dates

• First Submitted: October 29, 2019
• First Submitted That Met QC Criteria: November 18, 2019
• First Posted (Actual): November 21, 2019

Study Record Updates

• Last Update Posted (Actual): May 6, 2022
• Last Update Submitted That Met QC Criteria: May 2, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: randomized controlled trial; proteinuria; CKD; diet; vegan; plant-based diet
• Additional Relevant MeSH Terms: Urologic Diseases; Urological Manifestations; Renal Insufficiency; Urination Disorders; Kidney Diseases; Renal Insufficiency, Chronic; Proteinuria
• Other Study ID Numbers: STUDY00003490

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be made available for collaboration or other purposes with appropriate data use agreements in place.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No