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

Proteinuria Clinical Trial

Official title:

Effects of a Whole Food, Plant-Based Nutrition Program on Subjects With Chronic Kidney Disease and Proteinuria

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04171778
• Other study ID #: STUDY00003490
• Status: Terminated
• Phase: N/A
• Start date: December 5, 2019
• Est. completion date: March 28, 2022

Study information

• Verified date: May 2022
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: March 28, 2022
• Est. primary completion date: March 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease Stage 3B
• Chronic Kidney Disease, Stage 4
• Kidney Diseases
• Proteinuria
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
United States	Highland Hospital (University of Rochester)	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory stool microbiome evaluation	Changes in microbiome from baseline	12 weeks (RCT)
Primary	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)
Primary	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)
Primary	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	Weight changes from baseline		4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
Secondary	BMI changes from baseline		4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
Secondary	Waist circumference changes from baseline		4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
Secondary	8-point bioelectrical impedance analysis changes from baseline	Body composition assessment	12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
Secondary	Hemoglobin A1c changes from baseline	Diabetic control	4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
Secondary	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.	12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
Secondary	Serum potassium changes from baseline		1, 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
Secondary	Serum phosphorus changes from baseline		1, 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
Secondary	Serum albumin changes from baseline		1, 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
Secondary	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	1, 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
Secondary	Total cholesterol, HDL, LDL, and non-HDL cholesterol level changes from baseline	Fasting lipid panel	1, 4, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
Secondary	Serum magnesium changes from baseline		1, 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
Secondary	Parathyroid hormone (PTH) changes from baseline		12 weeks (RCT); 3 and 9 months on intervention diet (all subjects)
Secondary	25-hydroxycholecalciferol changes from baseline		12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
Secondary	Fibroblast growth factor-23 changes from baseline		12 weeks (RCT); 3 and 9 months on intervention diet (all subjects)
Secondary	High sensitivity CRP changes from baseline		12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
Secondary	CBC with differential changes from baseline		12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
Secondary	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	12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
Secondary	Changes in urinary indicators of dietary intake from baseline	24 hour urine collection, urinary oxidation (urinary 8-isoprostane)	12 weeks (RCT); 3 and 9 months on intervention diet (all subjects)