Clinical trial NCT06343129: Effects of a Whole-food, Plant-based Nutrition Program on BP and Potassium in Subjects With CKD
Official title: Effects of an Education Program Emphasizing a Whole-food, Plant-based Nutrition Program on Blood Pressure and Blood Potassium Levels in Subjects With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Diseases
Keywords: Diet
Plant-based
Whole food
Hypertension
Hyperkalemia
Blood pressure
Potassium
Systolic blood pressure
Diastolic blood pressure
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Rochester Lifestyle Medicine Institute
First posted: 2024-04-02
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if an educational program emphasizing a whole food plant based diet favorably impacts blood pressure while not significantly increasing blood potassium levels, by comparing a group of patients receiving the educational program with a control group of patients receiving no specific education.

Detailed description: The primary objective of this study is to test the hypothesis that educating hypertensive chronic kidney disease (CKD) stage 3 and 4 patients on the benefit of a whole food plant based (WFPB) diet in the context of a 15-day educational program ("Jumpstart program") will lead to improved blood pressure control and will not increase rates of hyperkalemia.

Other objectives:

A) To test the effect of the Jumpstart program on degree of uptake on a WFPB diet via a 3 day food recall.

B) To test the effect of the Jumpstart program on other important outcomes in CKD in the following domains:

1. Body composition such as weight and body mass index (BMI).
2. Quality of life.
3. Laboratory tests including- serum levels of sodium, bicarbonate, chloride, Blood urea nitrogen, creatinine, calcium, phosphorus, magnesium, albumin, parathyroid hormone, fibroblast growth factor 23, lipids, C-reactive protein and erythrocyte sedimentation rate.

C) To test the effect of the Jumpstart program on quality of life in hypertensive CKD patients.

Eligibility criteria: Inclusion Criteria:

* Age greater than 18 years
* Subjects with CKD 3 and 4 (as determined by an estimated glomerular filtration rate of ≥ 15 ml/min but \< 60 ml/min for at least three months)
* Subjects with hypertension, defined as use of antihypertension medication:
* Lack of significant proteinuria ( subjects will have a 24 hour urine protein value of \< 500 mg or a spot protein to creatinine ratio of \< 0.5 or a microalbumin to creatinine ratio \< 300) within previous 3 months.
* Fluent in English language
* Able and willing to comply with the testing schedule and the meeting schedule of the Jumpstart
* Able and willing to comply with dietary advice of whole-food plant based diet given during the educational session
* Able and willing to give informed consent
* Must have computer/internet access to participate in virtual Zoom educational sessions (intervention group only)

Exclusion Criteria:

* Kidney disease requiring immunosuppressive therapy
* Diabetes mellitus
* Pregnancy
* Life expectancy \< 12 months
* History of solid organ transplant or anticipated solid organ transplant in next 2 months
* History of hyperkalemia: (two or more potassium levels ≥ 5.0 Meq/L or those requiring intervention for high potassium levels within the last six months)
* Subjects with malabsorptive syndromes
* Subjects with history of bariatric surgery or planned bariatric surgery in the next 2 months
* Subjects on warfarin
* Subjects with documented eating disorder at the time of consent
* 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

Primary outcomes:
measure: Mean change in systolic blood pressure
timeFrame: Baseline to day 15
measure: Mean change in diastolic blood pressure
timeFrame: Baseline to day 15
measure: Mean change in potassium levels
timeFrame: Baseline to day 15
measure: Proportion of participants developing hyperkalemia
timeFrame: Day 15
Secondary outcomes:
measure: Mean Change in energy/day
timeFrame: Baseline to day 15
measure: Mean change in energy/kg of body mass
timeFrame: Baseline to day 15
measure: Mean change in total fat
timeFrame: Baseline to day 15
measure: Mean change in % calories from fat
timeFrame: Baseline to day 15
measure: Mean change in % calories from carbohydrates
timeFrame: Baseline to day 15
measure: Mean change in % calories from protein
timeFrame: Baseline to day 15
measure: Mean change in Animal protein
timeFrame: Baseline to day 15
measure: Mean change in Vegetable protein
timeFrame: Baseline to day 15
measure: Mean change in cholesterol
timeFrame: Baseline to day 15
measure: Mean change in Total dietary fiber
timeFrame: Baseline to day 15
measure: Mean change in Total fiber per 1000 kcal
timeFrame: Baseline to day 15
measure: Mean change in calcium
timeFrame: Baseline to day 15
measure: Mean change in phosphorous
timeFrame: Baseline to day 15
measure: Mean change in magnesium
timeFrame: Baseline to day 15
measure: Mean change in sodium
timeFrame: Baseline to day 15
measure: Mean change in potassium
timeFrame: Baseline to day 15
measure: Mean change in body mass
timeFrame: Baseline to day 15
measure: Mean change in body mass index
timeFrame: Baseline to day 15
measure: Mean change in sodium measured in blood
timeFrame: Baseline to day 15
measure: Mean change in chloride measured in blood
timeFrame: Baseline to day 15
measure: Mean change in bicarbonate measured in blood
timeFrame: Baseline to day 15
measure: Mean change in blood urea nitrogen (BUN) measured
timeFrame: Baseline to day 15
measure: Mean change in creatinine measured in blood
timeFrame: Baseline to day 15
measure: Mean change in glucose measured in blood
timeFrame: Baseline to day 15
measure: Mean change in calcium measured in blood
timeFrame: Baseline to day 15
measure: Mean change in phosphorous measured in blood
timeFrame: Baseline to day 15
measure: Mean change in parathyroid hormome (PTH) measured in blood
timeFrame: Baseline to day 15
measure: Mean change in albumin measured in blood
timeFrame: Baseline to day 15
measure: Mean change in magnesium measured in blood
timeFrame: Baseline to day 15
measure: Mean change in erythrocyte sedimentation rate (ESR) measured in blood
timeFrame: Baseline to day 15
measure: Mean change in fibroblast growth factor (FGF)-23 measured in blood
timeFrame: Baseline to day 15
measure: Mean change in total cholesterol measured in blood
timeFrame: Baseline to day 15
measure: Mean change in low density lipoprotein (LDL) measured in blood
timeFrame: Baseline to day 15
measure: Mean change in high density lipoprotein (HDL) measured in blood
timeFrame: Baseline to day 15
measure: Mean change in triglycerides measured in blood
timeFrame: Baseline to day 15
measure: Mean change in 8-isoprostane measured in urine
timeFrame: Baseline to day 15
measure: Mean change in symptoms
timeFrame: Baseline to day 15
measure: Mean change in effects of kidney disease
timeFrame: Baseline to day 15
measure: Mean change in burden of kidney disease
timeFrame: Baseline to day 15
measure: Mean change in Medical Outcomes Study Short Form (MOS SF-12) physical composite
timeFrame: Baseline to day 15
measure: Mean change in Medical Outcomes Study Short Form (MOS SF-12) mental composite
timeFrame: Baseline to day 15
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Clinical Research Center of the University of Rochester Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References: