Clinical trial NCT04171778: Effects of Whole Food, Plant-Based Nutrition on Chronic Kidney Disease With Proteinuria
Official title: Effects of a Whole Food, Plant-Based Nutrition Program on Subjects With Chronic Kidney Disease and Proteinuria
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Kidney Disease Stage 3B
Chronic Kidney Disease, Stage 4
Proteinuria
Keywords: CKD
proteinuria
diet
plant-based diet
vegan
randomized controlled trial
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2019-11-21
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The initial phase of the study will be a three month randomized clinical trial of a whole food plant based nutrition program vs. usual care in patients with chronic kidney disease. Subjects randomized to the intervention arm will start the nutrition program as soon as they are able.

Subjects assigned to the control arm will be placed on a 'wait-list' to start the nutrition program after they undergo three months of testing during their usual care, which consists of routine CKD care as directed by their primary nephrologist. After a 3 month 'wait', they will start the same plant-based nutrition program as the intervention arm subjects.

Both experimental and control group subjects will be followed for a total of 9 months after starting the plant-based dietary intervention. Thus, in addition to the 3-month randomized control trial, there will be data from a 9-month single arm clinical intervention.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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)
measure: Change in proteinuria from baseline
timeFrame: 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
measure: Change in GFR from baseline
timeFrame: 1, 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
Secondary outcomes:
measure: Weight changes from baseline
timeFrame: 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
measure: BMI changes from baseline
timeFrame: 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
measure: Waist circumference changes from baseline
timeFrame: 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
measure: 8-point bioelectrical impedance analysis changes from baseline
timeFrame: 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
measure: Hemoglobin A1c changes from baseline
timeFrame: 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
measure: KDQOL-36 changes from baseline
timeFrame: 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
measure: Serum potassium changes from baseline
timeFrame: 1, 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
measure: Serum phosphorus changes from baseline
timeFrame: 1, 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
measure: Serum albumin changes from baseline
timeFrame: 1, 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
measure: Blood glucose level changes from baseline
timeFrame: 1, 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
measure: Total cholesterol, HDL, LDL, and non-HDL cholesterol level changes from baseline
timeFrame: 1, 4, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
measure: Serum magnesium changes from baseline
timeFrame: 1, 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
measure: Parathyroid hormone (PTH) changes from baseline
timeFrame: 12 weeks (RCT); 3 and 9 months on intervention diet (all subjects)
measure: 25-hydroxycholecalciferol changes from baseline
timeFrame: 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
measure: Fibroblast growth factor-23 changes from baseline
timeFrame: 12 weeks (RCT); 3 and 9 months on intervention diet (all subjects)
measure: High sensitivity CRP changes from baseline
timeFrame: 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
measure: CBC with differential changes from baseline
timeFrame: 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
measure: Changes in nutrient intakes from baseline based on 3 day food diaries
timeFrame: 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
measure: Changes in urinary indicators of dietary intake from baseline
timeFrame: 12 weeks (RCT); 3 and 9 months on intervention diet (all subjects)
Other outcomes:
measure: Exploratory stool microbiome evaluation
timeFrame: 12 weeks (RCT)
Locations:
city: Rochester
country: United States
facility: Highland Hospital (University of Rochester)
state: New York
Study officials:
affiliation: University of Rochester
name: Erin Campbell, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rochester
name: Scott E Liebman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: