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

NCT04171778 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2022-05-06

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • University of Rochester

    lead OTHER

Principal Investigators

  • Erin Campbell, MD, MPH · University of Rochester

  • Scott E Liebman, MD, MPH · University of Rochester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-05
Primary Completion
2022-03-28
Completion
2022-03-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04171778 on ClinicalTrials.gov