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

NCT04171778 | Terminated

• 1 other identifier: STUDY00003490
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Change in systolic and diastolic blood pressure from baseline

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

• Change in proteinuria from baseline

  Urine total protein:creatinine ratio

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

• Change in GFR from baseline

  Serum creatinine (renal function panel) and Cystatin C

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

Secondary Outcomes (19)

• Weight changes from baseline

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

• BMI changes from baseline

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

• Waist circumference changes from baseline

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

• 8-point bioelectrical impedance analysis changes from baseline

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

• Hemoglobin A1c changes from baseline

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

Other Outcomes (1)

• Exploratory stool microbiome evaluation

  12 weeks (RCT)

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Other: whole food, plant-based diet

Wait List Control

OTHER

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.

Other: whole food, plant-based diet

Interventions

whole food, plant-based diet 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.

Intervention; Wait List Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

Highland Hospital (University of Rochester)

Rochester, New York, 14620, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Proteinuria

Interventions

Diet, Plant-Based

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urological Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Erin Campbell, MD, MPH

  University of Rochester

  PRINCIPAL INVESTIGATOR

• Scott E Liebman, MD, MPH

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: November 21, 2019
• Study Start: December 5, 2019
• Primary Completion: March 28, 2022
• Study Completion: March 28, 2022
• Last Updated: May 6, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)