Chronic Kidney Disease Stage 3BNCT04171778

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

A study testing whole food, plant-based diet in people with Chronic Kidney Disease Stage 3B and Chronic Kidney Disease, Stage 4, run by University of Rochester at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Kidney Disease Stage 3B, Chronic Kidney Disease, Stage 4, Proteinuria
What is being tested?: whole food, plant-based diet
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3 participants
Where: 1 siteUnited States
Study dates: 5 Dec 2019to 28 Mar 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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

Who cannot join

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

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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

Trial locations and contacts

1 site in 1 country.

United States1 site

Highland Hospital (University of Rochester)
Rochester, New York, 14620

Other trials in United States

About this study

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

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
Being tested: whole food, plant-based diet
Keywords: CKD, proteinuria, diet, plant-based diet, vegan, randomized controlled trial
Medical subject headings: Renal Insufficiency, Chronic, Proteinuria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

whole food, plant-based dietOther
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.

Study groups in NCT04171778
Study group	Role	What they receive
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. Receives: 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. Receives: Other: whole food, plant-based diet

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in systolic and diastolic blood pressure from baseline
Measured: 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
Measured: 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
Measured: 1, 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)

Secondary outcomes (19)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Dec 201928 Mar 2022

First posted21 Nov 2019
Study start5 Dec 2019
Primary completion28 Mar 2022
Study completion28 Mar 2022

Why it stopped: Substantially redesigning study protocol and opening a new study in the future.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic Kidney Disease Stage 3BStudies of the same condition, open and under way.
More trials run by University of RochesterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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)
Enrolment: 3 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04171778
Sponsor's protocol ID: STUDY00003490
Status last verified: May 2022
First submitted: 29 Oct 2019
Last updated: 6 May 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Data will be made available for collaboration or other purposes with appropriate data use agreements in place.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of a Whole Food, Plant-Based Nutrition Program on Subjects With Chronic Kidney Disease and Proteinuria
ClinicalTrials.gov ID: NCT04171778
Acronym / sponsor ID: STUDY00003490
Conditions: Chronic Kidney Disease Stage 3B, Chronic Kidney Disease, Stage 4, Proteinuria
Keywords: CKD, proteinuria, diet, plant-based diet, vegan, randomized controlled trial
Study type: Interventional
Recruitment status: TerminatedReason stopped: Substantially redesigning study protocol and opening a new study in the future.
Enrolment: 3 participants (actual)
Lead sponsor: University of RochesterUniversity, hospital or other
Study start: 5 Dec 2019 (actual)
Primary completion: 28 Mar 2022 (actual)
Study completion: 28 Mar 2022 (actual)
First posted: 21 Nov 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
Intervention	Experimental	Other: whole food, plant-based dietSubjects 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.
Wait List Control	Other	Other: whole food, plant-based dietSubjects 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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:
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

Key exclusion criteria (14 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
whole food, plant-based dietThe 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.	Other	Intervention, Wait List Control

Primary outcome

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)
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
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

19 secondary outcomes

Weight changes from baseline
Time frame: 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
BMI changes from baseline
Time frame: 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
Waist circumference changes from baseline
Time frame: 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
8-point bioelectrical impedance analysis changes from baseline
Time frame: 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
Hemoglobin A1c changes from baseline
Time frame: 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
KDQOL-36 changes from baseline
Time frame: 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
Serum potassium changes from baseline
Time frame: 1, 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
Serum phosphorus changes from baseline
Time frame: 1, 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
Serum albumin changes from baseline
Time frame: 1, 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
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)
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)
Serum magnesium changes from baseline
Time frame: 1, 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
Parathyroid hormone (PTH) changes from baseline
Time frame: 12 weeks (RCT); 3 and 9 months on intervention diet (all subjects)
25-hydroxycholecalciferol changes from baseline
Time frame: 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
Fibroblast growth factor-23 changes from baseline
Time frame: 12 weeks (RCT); 3 and 9 months on intervention diet (all subjects)
High sensitivity CRP changes from baseline
Time frame: 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
CBC with differential changes from baseline
Time frame: 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
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)
Changes in urinary indicators of dietary intake from baseline
Time frame: 12 weeks (RCT); 3 and 9 months on intervention diet (all subjects)

Results and safety

The study was stopped early (reason given: Substantially redesigning study protocol and opening a new study in the future.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
Individual participant dataSharing planned: No. Data will be made available for collaboration or other purposes with appropriate data use agreements in place.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Erin Campbell, MD, MPH principal investigator

University of Rochester

Scott E Liebman, MD, MPH principal investigator

University of Rochester

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing whole food, plant-based diet in people with Chronic Kidney Disease Stage 3B and Chronic Kidney Disease, Stage 4, run by University of Rochester at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Substantially redesigning study protocol and opening a new study in the future.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04171778.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2022.