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

Primary Purpose

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

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

whole food, plant-based diet

About this trial

This is an interventional treatment trial for Chronic Kidney Disease Stage 3B focused on measuring CKD, proteinuria, diet, plant-based diet, vegan, randomized controlled trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Highland Hospital (University of Rochester)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention

Wait List Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in systolic and diastolic blood pressure from baseline

Change in proteinuria from baseline

Urine total protein:creatinine ratio

Change in GFR from baseline

Serum creatinine (renal function panel) and Cystatin C

Secondary Outcome Measures

Weight changes from baseline

BMI changes from baseline

Waist circumference changes from baseline

8-point bioelectrical impedance analysis changes from baseline

Body composition assessment

Hemoglobin A1c changes from baseline

Diabetic control

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.

Serum potassium changes from baseline

Serum phosphorus changes from baseline

Serum albumin changes from baseline

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

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

Fasting lipid panel

Serum magnesium changes from baseline

Parathyroid hormone (PTH) changes from baseline

25-hydroxycholecalciferol changes from baseline

Fibroblast growth factor-23 changes from baseline

High sensitivity CRP changes from baseline

CBC with differential changes from baseline

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

Changes in urinary indicators of dietary intake from baseline

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

Full Information

NCT ID

NCT04171778

First Posted

October 29, 2019

Last Updated

May 2, 2022

Sponsor

University of Rochester

1. Study Identification

Unique Protocol Identification Number

NCT04171778

Brief Title

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

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Terminated

Why Stopped

Substantially redesigning study protocol and opening a new study in the future.

Study Start Date

December 5, 2019 (Actual)

Primary Completion Date

March 28, 2022 (Actual)

Study Completion Date

March 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Rochester

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

CKD, proteinuria, diet, plant-based diet, vegan, randomized controlled trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

Arm Title

Wait List Control

Arm Type

Other

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

whole food, plant-based diet

Intervention Description

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.

Primary Outcome Measure Information:

Title

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)

Title

Change in proteinuria from baseline

Description

Urine total protein:creatinine ratio

Time Frame

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

Title

Change in GFR from baseline

Description

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 Outcome Measure Information:

Title

Weight changes from baseline

Time Frame

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

Title

BMI changes from baseline

Time Frame

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

Title

Waist circumference changes from baseline

Time Frame

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

Title

8-point bioelectrical impedance analysis changes from baseline

Description

Body composition assessment

Time Frame

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

Title

Hemoglobin A1c changes from baseline

Description

Diabetic control

Time Frame

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

Title

KDQOL-36 changes from baseline

Description

Time Frame

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

Title

Serum potassium changes from baseline

Time Frame

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

Title

Serum phosphorus changes from baseline

Time Frame

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

Title

Serum albumin changes from baseline

Time Frame

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

Title

Blood glucose level changes from baseline

Description

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)

Title

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

Description

Fasting lipid panel

Time Frame

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

Title

Serum magnesium changes from baseline

Time Frame

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

Title

Parathyroid hormone (PTH) changes from baseline

Time Frame

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

Title

25-hydroxycholecalciferol changes from baseline

Time Frame

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

Title

Fibroblast growth factor-23 changes from baseline

Time Frame

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

Title

High sensitivity CRP changes from baseline

Time Frame

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

Title

CBC with differential changes from baseline

Time Frame

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

Title

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

Description

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)

Title

Changes in urinary indicators of dietary intake from baseline

Description

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

Time Frame

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

Other Pre-specified Outcome Measures:

Title

Exploratory stool microbiome evaluation

Description

Changes in microbiome from baseline

Time Frame

12 weeks (RCT)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Erin Campbell, MD, MPH

Organizational Affiliation

University of Rochester

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Scott E Liebman, MD, MPH

Organizational Affiliation

University of Rochester

Official's Role

Principal Investigator

Facility Information:

Facility Name

Highland Hospital (University of Rochester)

City

Rochester

State/Province

New York

ZIP/Postal Code

14620

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Data will be made available for collaboration or other purposes with appropriate data use agreements in place.

Learn more about this trial

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

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