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

NCT04171778•University of Rochester

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

Age

18 - No limit years

Sex

ALL

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
+4 more criteria

Locations (1)

Highland Hospital (University of Rochester)

Rochester, New York, United States

Key Dates

Start Date

December 5, 2019

Primary Completion Date

March 28, 2022

Completion Date

March 28, 2022

Last Updated

May 6, 2022

Enrollment

ACTUAL participants

Conditions

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

Interventions

whole food, plant-based diet

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 6, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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

Inclusion Criteria

Exclusion Criteria

Effects of Exogenous Ketosis on Proteinuria and Renal Function

Improving Renal Complications in Adolescents With Type 2 Diabetes Through REsearch Cohort Study (National iCARE Study)

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CHART-C3G/CLNP023B12011