Effects of a Whole-food, Plant-based Nutrition Program on BP and Potassium in Subjects With CKD

Chronic Kidney Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06343129
• Other study ID #: 3817
• Status: Completed
• Phase: N/A
• Start date: October 26, 2020
• Est. completion date: December 12, 2022

Study information

• Verified date: April 2024
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 12, 2022
• Est. primary completion date: December 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• Dietary education program
Jumpstart educational program: https://www.rochesterlifestylemedicine.com/about-community-jumpstart/

Locations

Country	Name	City	State
United States	Clinical Research Center of the University of Rochester Medical Center	Rochester	New York
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	Rochester Lifestyle Medicine Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in systolic blood pressure	Unit of measurement - mm Hg	Baseline to day 15
Primary	Mean change in diastolic blood pressure	Unit of measurement - mm Hg	Baseline to day 15
Primary	Mean change in potassium levels	Unit of measurement - mEq/L	Baseline to day 15
Primary	Proportion of participants developing hyperkalemia	Percentage	Day 15
Secondary	Mean Change in energy/day	Unit of measurement - kcal/day. Subjects completed a 3-day food record prior to intervention and during Jumpstart (or equivalent time for controls). Participants were given a recording form, and verbal and written instructions to record relevant details for all foods and beverages consumed. Portion size was estimated, using food visual aids, or measured, using weight scales or volume measures. A research dietitian (NW) provided the food record instruction and reviewed the completed records with participants to increase the quality of the report. The food record data was then entered into the Nutrition Data System for Research (NSDR, Nutrition Coordinating Center, University of Minnesota, Twin Cities) for calculation of nutrient intake.	Baseline to day 15
Secondary	Mean change in energy/kg of body mass	Unit of measurement - kcal/kg/day. Subjects completed a 3-day food record prior to intervention and during Jumpstart (or equivalent time for controls). Participants were given a recording form, and verbal and written instructions to record relevant details for all foods and beverages consumed. Portion size was estimated, using food visual aids, or measured, using weight scales or volume measures. A research dietitian (NW) provided the food record instruction and reviewed the completed records with participants to increase the quality of the report. The food record data was then entered into the Nutrition Data System for Research (NSDR, Nutrition Coordinating Center, University of Minnesota, Twin Cities) for calculation of nutrient intake.	Baseline to day 15
Secondary	Mean change in total fat	Unit of measurement - grams. Subjects completed a 3-day food record prior to intervention and during Jumpstart (or equivalent time for controls). Participants were given a recording form, and verbal and written instructions to record relevant details for all foods and beverages consumed. Portion size was estimated, using food visual aids, or measured, using weight scales or volume measures. A research dietitian (NW) provided the food record instruction and reviewed the completed records with participants to increase the quality of the report. The food record data was then entered into the Nutrition Data System for Research (NSDR, Nutrition Coordinating Center, University of Minnesota, Twin Cities) for calculation of nutrient intake.	Baseline to day 15
Secondary	Mean change in % calories from fat	Unit of measurement - Percentage. Subjects completed a 3-day food record prior to intervention and during Jumpstart (or equivalent time for controls). Participants were given a recording form, and verbal and written instructions to record relevant details for all foods and beverages consumed. Portion size was estimated, using food visual aids, or measured, using weight scales or volume measures. A research dietitian (NW) provided the food record instruction and reviewed the completed records with participants to increase the quality of the report. The food record data was then entered into the Nutrition Data System for Research (NSDR, Nutrition Coordinating Center, University of Minnesota, Twin Cities) for calculation of nutrient intake.	Baseline to day 15
Secondary	Mean change in % calories from carbohydrates	Unit of measurement - Percentage. Subjects completed a 3-day food record prior to intervention and during Jumpstart (or equivalent time for controls). Participants were given a recording form, and verbal and written instructions to record relevant details for all foods and beverages consumed. Portion size was estimated, using food visual aids, or measured, using weight scales or volume measures. A research dietitian (NW) provided the food record instruction and reviewed the completed records with participants to increase the quality of the report. The food record data was then entered into the Nutrition Data System for Research (NSDR, Nutrition Coordinating Center, University of Minnesota, Twin Cities) for calculation of nutrient intake.	Baseline to day 15
Secondary	Mean change in % calories from protein	Unit of measurement - Percentage. Subjects completed a 3-day food record prior to intervention and during Jumpstart (or equivalent time for controls). Participants were given a recording form, and verbal and written instructions to record relevant details for all foods and beverages consumed. Portion size was estimated, using food visual aids, or measured, using weight scales or volume measures. A research dietitian (NW) provided the food record instruction and reviewed the completed records with participants to increase the quality of the report. The food record data was then entered into the Nutrition Data System for Research (NSDR, Nutrition Coordinating Center, University of Minnesota, Twin Cities) for calculation of nutrient intake.	Baseline to day 15
Secondary	Mean change in Animal protein	Unit of measurement - grams. Subjects completed a 3-day food record prior to intervention and during Jumpstart (or equivalent time for controls). Participants were given a recording form, and verbal and written instructions to record relevant details for all foods and beverages consumed. Portion size was estimated, using food visual aids, or measured, using weight scales or volume measures. A research dietitian (NW) provided the food record instruction and reviewed the completed records with participants to increase the quality of the report. The food record data was then entered into the Nutrition Data System for Research (NSDR, Nutrition Coordinating Center, University of Minnesota, Twin Cities) for calculation of nutrient intake.	Baseline to day 15
Secondary	Mean change in Vegetable protein	Unit of measurement - grams. Subjects completed a 3-day food record prior to intervention and during Jumpstart (or equivalent time for controls). Participants were given a recording form, and verbal and written instructions to record relevant details for all foods and beverages consumed. Portion size was estimated, using food visual aids, or measured, using weight scales or volume measures. A research dietitian (NW) provided the food record instruction and reviewed the completed records with participants to increase the quality of the report. The food record data was then entered into the Nutrition Data System for Research (NSDR, Nutrition Coordinating Center, University of Minnesota, Twin Cities) for calculation of nutrient intake.	Baseline to day 15
Secondary	Mean change in cholesterol	Unit of measurement - milligrams. Subjects completed a 3-day food record prior to intervention and during Jumpstart (or equivalent time for controls). Participants were given a recording form, and verbal and written instructions to record relevant details for all foods and beverages consumed. Portion size was estimated, using food visual aids, or measured, using weight scales or volume measures. A research dietitian (NW) provided the food record instruction and reviewed the completed records with participants to increase the quality of the report. The food record data was then entered into the Nutrition Data System for Research (NSDR, Nutrition Coordinating Center, University of Minnesota, Twin Cities) for calculation of nutrient intake.	Baseline to day 15
Secondary	Mean change in Total dietary fiber	Unit of measurement - grams. Subjects completed a 3-day food record prior to intervention and during Jumpstart (or equivalent time for controls). Participants were given a recording form, and verbal and written instructions to record relevant details for all foods and beverages consumed. Portion size was estimated, using food visual aids, or measured, using weight scales or volume measures. A research dietitian (NW) provided the food record instruction and reviewed the completed records with participants to increase the quality of the report. The food record data was then entered into the Nutrition Data System for Research (NSDR, Nutrition Coordinating Center, University of Minnesota, Twin Cities) for calculation of nutrient intake.	Baseline to day 15
Secondary	Mean change in Total fiber per 1000 kcal	Unit of measurement - Subjects completed a 3-day food record prior to intervention and during Jumpstart (or equivalent time for controls). Participants were given a recording form, and verbal and written instructions to record relevant details for all foods and beverages consumed. Portion size was estimated, using food visual aids, or measured, using weight scales or volume measures. A research dietitian (NW) provided the food record instruction and reviewed the completed records with participants to increase the quality of the report. The food record data was then entered into the Nutrition Data System for Research (NSDR, Nutrition Coordinating Center, University of Minnesota, Twin Cities) for calculation of nutrient intake.	Baseline to day 15
Secondary	Mean change in calcium	Unit of measurement - milligrams. Subjects completed a 3-day food record prior to intervention and during Jumpstart (or equivalent time for controls). Participants were given a recording form, and verbal and written instructions to record relevant details for all foods and beverages consumed. Portion size was estimated, using food visual aids, or measured, using weight scales or volume measures. A research dietitian (NW) provided the food record instruction and reviewed the completed records with participants to increase the quality of the report. The food record data was then entered into the Nutrition Data System for Research (NSDR, Nutrition Coordinating Center, University of Minnesota, Twin Cities) for calculation of nutrient intake.	Baseline to day 15
Secondary	Mean change in phosphorous	Unit of measurement - milligrams. Subjects completed a 3-day food record prior to intervention and during Jumpstart (or equivalent time for controls). Participants were given a recording form, and verbal and written instructions to record relevant details for all foods and beverages consumed. Portion size was estimated, using food visual aids, or measured, using weight scales or volume measures. A research dietitian (NW) provided the food record instruction and reviewed the completed records with participants to increase the quality of the report. The food record data was then entered into the Nutrition Data System for Research (NSDR, Nutrition Coordinating Center, University of Minnesota, Twin Cities) for calculation of nutrient intake.	Baseline to day 15
Secondary	Mean change in magnesium	Unit of measurement - milligrams. Subjects completed a 3-day food record prior to intervention and during Jumpstart (or equivalent time for controls). Participants were given a recording form, and verbal and written instructions to record relevant details for all foods and beverages consumed. Portion size was estimated, using food visual aids, or measured, using weight scales or volume measures. A research dietitian (NW) provided the food record instruction and reviewed the completed records with participants to increase the quality of the report. The food record data was then entered into the Nutrition Data System for Research (NSDR, Nutrition Coordinating Center, University of Minnesota, Twin Cities) for calculation of nutrient intake.	Baseline to day 15
Secondary	Mean change in sodium	Unit of measurement - milligrams. Subjects completed a 3-day food record prior to intervention and during Jumpstart (or equivalent time for controls). Participants were given a recording form, and verbal and written instructions to record relevant details for all foods and beverages consumed. Portion size was estimated, using food visual aids, or measured, using weight scales or volume measures. A research dietitian (NW) provided the food record instruction and reviewed the completed records with participants to increase the quality of the report. The food record data was then entered into the Nutrition Data System for Research (NSDR, Nutrition Coordinating Center, University of Minnesota, Twin Cities) for calculation of nutrient intake.	Baseline to day 15
Secondary	Mean change in potassium	Unit of measurement - milligrams. Subjects completed a 3-day food record prior to intervention and during Jumpstart (or equivalent time for controls). Participants were given a recording form, and verbal and written instructions to record relevant details for all foods and beverages consumed. Portion size was estimated, using food visual aids, or measured, using weight scales or volume measures. A research dietitian (NW) provided the food record instruction and reviewed the completed records with participants to increase the quality of the report. The food record data was then entered into the Nutrition Data System for Research (NSDR, Nutrition Coordinating Center, University of Minnesota, Twin Cities) for calculation of nutrient intake.	Baseline to day 15
Secondary	Mean change in body mass	Unit of measurement - kilograms. Subjects completed a 3-day food record prior to intervention and during Jumpstart (or equivalent time for controls). Participants were given a recording form, and verbal and written instructions to record relevant details for all foods and beverages consumed. Portion size was estimated, using food visual aids, or measured, using weight scales or volume measures. A research dietitian (NW) provided the food record instruction and reviewed the completed records with participants to increase the quality of the report. The food record data was then entered into the Nutrition Data System for Research (NSDR, Nutrition Coordinating Center, University of Minnesota, Twin Cities) for calculation of nutrient intake.	Baseline to day 15
Secondary	Mean change in body mass index	Unit of measurement - kg/m². Subjects completed a 3-day food record prior to intervention and during Jumpstart (or equivalent time for controls). Participants were given a recording form, and verbal and written instructions to record relevant details for all foods and beverages consumed. Portion size was estimated, using food visual aids, or measured, using weight scales or volume measures. A research dietitian (NW) provided the food record instruction and reviewed the completed records with participants to increase the quality of the report. The food record data was then entered into the Nutrition Data System for Research (NSDR, Nutrition Coordinating Center, University of Minnesota, Twin Cities) for calculation of nutrient intake.	Baseline to day 15
Secondary	Mean change in sodium measured in blood	Unit of measurement - mEq/L	Baseline to day 15
Secondary	Mean change in chloride measured in blood	Unit of measurement - mEq/L	Baseline to day 15
Secondary	Mean change in bicarbonate measured in blood	Unit of measurement - mEq/L	Baseline to day 15
Secondary	Mean change in blood urea nitrogen (BUN) measured	Unit of measurement - mg/dl	Baseline to day 15
Secondary	Mean change in creatinine measured in blood	Unit of measurement - mg/dl	Baseline to day 15
Secondary	Mean change in glucose measured in blood	Unit of measurement - mg/dl	Baseline to day 15
Secondary	Mean change in calcium measured in blood	Unit of measurement - mg/dl	Baseline to day 15
Secondary	Mean change in phosphorous measured in blood	Unit of measurement - mg/dl	Baseline to day 15
Secondary	Mean change in parathyroid hormome (PTH) measured in blood	Unit of measurement - pg/mL	Baseline to day 15
Secondary	Mean change in albumin measured in blood	Unit of measurement - pg/mL	Baseline to day 15
Secondary	Mean change in magnesium measured in blood	Unit of measurement - mEq/L	Baseline to day 15
Secondary	Mean change in erythrocyte sedimentation rate (ESR) measured in blood	Unit of measurement - mm/hr	Baseline to day 15
Secondary	Mean change in fibroblast growth factor (FGF)-23 measured in blood	Unit of measurement - RU/ml	Baseline to day 15
Secondary	Mean change in total cholesterol measured in blood	Unit of measurement - mg/dl	Baseline to day 15
Secondary	Mean change in low density lipoprotein (LDL) measured in blood	Unit of measurement - mg/dl	Baseline to day 15
Secondary	Mean change in high density lipoprotein (HDL) measured in blood	Unit of measurement - mg/dl	Baseline to day 15
Secondary	Mean change in triglycerides measured in blood	Unit of measurement - mg/dl	Baseline to day 15
Secondary	Mean change in 8-isoprostane measured in urine	Unit of measurement - (ng/mg of creat)/kg	Baseline to day 15
Secondary	Mean change in symptoms	Higher scores indicate better health. Scores are transformed linearly to 0-100 range.; The symptom list assesses the extent of bother (not at all, somewhat, moderately, very much, extremely) during the last 30 days in terms of issues particularly relevant to patients with kidney disease including soreness in muscles, pain (joint,back, chest), headaches, cramps during dialysis, bruising, itchy skin, shortness of breath, dizziness, lack of appetite, excessive thirst, numbness in hands or feet, trouble with memory, blurred vision, nausea, or other problems with the access site.	Baseline to day 15
Secondary	Mean change in effects of kidney disease	Higher scores indicate better health. Scores are transformed linearly to 0-100 range.; Effects of kidney disease on daily life were assessed using the same five-point response scale used for the symptom/problem list and included restrictions on fluid and dietary intake, and impact on work, carrying out family responsibilities, travel, lifting objects, personal appearance, and time available to get things done.	Baseline to day 15
Secondary	Mean change in burden of kidney disease	Higher scores indicate better health. Scores are transformed linearly to 0-100 range.; The burden of kidney disease scale assesses perceptions of frustration and interference of kidney disease in one's life using a definitely true to definitely false response scale (interferes too much with life, too much time spent dealing with it, feel frustrated dealing with it, feel like a burden on family).	Baseline to day 15
Secondary	Mean change in Medical Outcomes Study Short Form (MOS SF-12) physical composite	Higher scores indicate better health. Scores are transformed linearly to 0-100 range.; Physical composite includes questions on how you feel about your physical health. In the survey, participants are asked if they could do things like climb stairs, move a table, or push a vacuum. How well they think they feel physically is a key measure of their health.	Baseline to day 15
Secondary	Mean change in Medical Outcomes Study Short Form (MOS SF-12) mental composite	Higher scores indicate better health. Scores are transformed linearly to 0-100 range.; Mental composite includes questions about general health, activity limits, ability to accomplish desired tasks, depression and anxiety, energy level, and social activities.	Baseline to day 15