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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04171778
Recruitment Status : Recruiting
First Posted : November 21, 2019
Last Update Posted : February 12, 2020
Sponsor:
Information provided by (Responsible Party):
Erin Campbell, University of Rochester

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Stage 3B Chronic Kidney Disease, Stage 4 Proteinuria Other: whole food, plant-based diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of a Whole Food, Plant-Based Nutrition Program on Subjects With Chronic Kidney Disease and Proteinuria
Actual Study Start Date : December 5, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: 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.
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.

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.
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.




Primary Outcome Measures :
  1. Change in systolic and diastolic blood pressure from baseline [ Time Frame: 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects) ]
  2. Change in proteinuria from baseline [ Time Frame: 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects) ]
    Urine total protein:creatinine ratio

  3. Change in GFR from baseline [ Time Frame: 1, 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects) ]
    Serum creatinine (renal function panel) and Cystatin C


Secondary Outcome Measures :
  1. Weight changes from baseline [ Time Frame: 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects) ]
  2. BMI changes from baseline [ Time Frame: 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects) ]
  3. Waist circumference changes from baseline [ Time Frame: 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects) ]
  4. 8-point bioelectrical impedance analysis changes from baseline [ Time Frame: 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects) ]
    Body composition assessment

  5. Hemoglobin A1c changes from baseline [ Time Frame: 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects) ]
    Diabetic control

  6. KDQOL-36 changes from baseline [ Time Frame: 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects) ]
    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.

  7. Serum potassium changes from baseline [ Time Frame: 1, 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects) ]
  8. Serum phosphorus changes from baseline [ Time Frame: 1, 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects) ]
  9. Serum albumin changes from baseline [ Time Frame: 1, 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects) ]
  10. Blood glucose level changes from baseline [ Time Frame: 1, 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects) ]
    Fasting serum levels from all subjects; additionally, whole blood levels measured by glucometer in subjects with comorbid type 1 or type 2 diabetes mellitus

  11. Total cholesterol, HDL, LDL, and non-HDL cholesterol level changes from baseline [ Time Frame: 1, 4, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects) ]
    Fasting lipid panel

  12. Serum magnesium changes from baseline [ Time Frame: 1, 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects) ]
  13. Parathyroid hormone (PTH) changes from baseline [ Time Frame: 12 weeks (RCT); 3 and 9 months on intervention diet (all subjects) ]
  14. 25-hydroxycholecalciferol changes from baseline [ Time Frame: 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects) ]
  15. Fibroblast growth factor-23 changes from baseline [ Time Frame: 12 weeks (RCT); 3 and 9 months on intervention diet (all subjects) ]
  16. High sensitivity CRP changes from baseline [ Time Frame: 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects) ]
  17. CBC with differential changes from baseline [ Time Frame: 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects) ]
  18. Changes in nutrient intakes from baseline based on 3 day food diaries [ Time Frame: 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects) ]
    Assess baseline compared to intervention diet and assess compliance of intervention diet over study duration

  19. Changes in urinary indicators of dietary intake from baseline [ Time Frame: 12 weeks (RCT); 3 and 9 months on intervention diet (all subjects) ]
    24 hour urine collection, urinary oxidation (urinary 8-isoprostane)


Other Outcome Measures:
  1. Exploratory stool microbiome evaluation [ Time Frame: 12 weeks (RCT) ]
    Changes in microbiome from baseline



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04171778


Contacts
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Contact: Erin Campbell, MD, MPH (585) 341-9899 Erin_Campbell@urmc.rochester.edu
Contact: Thomas M Campbell, MD (585) 341-9899 Thomas_Campbell@urmc.rochester.edu

Locations
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United States, New York
Highland Hospital (University of Rochester) Recruiting
Rochester, New York, United States, 14620
Contact: Erin Campbell, MD, MPH         
Sponsors and Collaborators
University of Rochester
Investigators
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Principal Investigator: Erin Campbell, MD, MPH University of Rochester
Principal Investigator: Scott E Liebman, MD, MPH University of Rochester
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Responsible Party: Erin Campbell, Clinical Assistant Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT04171778    
Other Study ID Numbers: STUDY00003490
First Posted: November 21, 2019    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be made available for collaboration or other purposes with appropriate data use agreements in place.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Erin Campbell, University of Rochester:
CKD
proteinuria
diet
plant-based diet
vegan
randomized controlled trial
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Proteinuria
Urologic Diseases
Renal Insufficiency
Urination Disorders
Urological Manifestations
Signs and Symptoms