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

NCT ID: NCT04171778

Last Updated: 2022-05-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-05
• Study Completion Date: 2022-03-28

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

whole food, plant-based diet

Intervention Type: OTHER

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.

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.

Group Type: OTHER

whole food, plant-based diet

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Erin Campbell

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Erin Campbell, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Scott E Liebman, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

Highland Hospital (University of Rochester)

Rochester, New York, United States

Countries

United States

Other Identifiers

STUDY00003490

Identifier Type: -

Identifier Source: org_study_id