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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04171778
Other study ID # STUDY00003490
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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)
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