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Completed

NCT Number: NCT06343129

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

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.

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Key information

Conditions

Chronic Kidney Diseases Cardiovascular Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hyperkalemia Hypertension Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Diseases Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Research Center of the University of Rochester Medical Center, Rochester, New York, United States

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About this study

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:

  • Body composition such as weight and body mass index (BMI).
  • Quality of life.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary education program

Behavioral

Jumpstart educational program:

https://www.rochesterlifestylemedicine.com/about-community-jumpstart/

Other names: Nutritional education program

Primary outcomes

  1. Mean change in systolic blood pressure

    Time frame: Baseline to day 15

    Unit of measurement - mm Hg

  2. Mean change in diastolic blood pressure

    Time frame: Baseline to day 15

    Unit of measurement - mm Hg

  3. Mean change in potassium levels

    Time frame: Baseline to day 15

    Unit of measurement - mEq/L

  4. Proportion of participants developing hyperkalemia

    Time frame: Day 15

    Percentage

Secondary outcomes

  1. Mean Change in energy/day

    Time frame: Baseline to day 15

    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.

  2. Mean change in energy/kg of body mass

    Time frame: Baseline to day 15

    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.

  3. Mean change in total fat

    Time frame: Baseline to day 15

    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.

  4. Mean change in % calories from fat

    Time frame: Baseline to day 15

    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.

  5. Mean change in % calories from carbohydrates

    Time frame: Baseline to day 15

    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.

  6. Mean change in % calories from protein

    Time frame: Baseline to day 15

    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.

  7. Mean change in Animal protein

    Time frame: Baseline to day 15

    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.

  8. Mean change in Vegetable protein

    Time frame: Baseline to day 15

    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.

  9. Mean change in cholesterol

    Time frame: Baseline to day 15

    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.

  10. Mean change in Total dietary fiber

    Time frame: Baseline to day 15

    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.

  11. Mean change in Total fiber per 1000 kcal

    Time frame: Baseline to day 15

    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.

  12. Mean change in calcium

    Time frame: Baseline to day 15

    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.

  13. Mean change in phosphorous

    Time frame: Baseline to day 15

    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.

  14. Mean change in magnesium

    Time frame: Baseline to day 15

    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.

  15. Mean change in sodium

    Time frame: Baseline to day 15

    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.

  16. Mean change in potassium

    Time frame: Baseline to day 15

    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.

  17. Mean change in body mass

    Time frame: Baseline to day 15

    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.

  18. Mean change in body mass index

    Time frame: Baseline to day 15

    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.

  19. Mean change in sodium measured in blood

    Time frame: Baseline to day 15

    Unit of measurement - mEq/L

  20. Mean change in chloride measured in blood

    Time frame: Baseline to day 15

    Unit of measurement - mEq/L

  21. Mean change in bicarbonate measured in blood

    Time frame: Baseline to day 15

    Unit of measurement - mEq/L

  22. Mean change in blood urea nitrogen (BUN) measured

    Time frame: Baseline to day 15

    Unit of measurement - mg/dl

  23. Mean change in creatinine measured in blood

    Time frame: Baseline to day 15

    Unit of measurement - mg/dl

  24. Mean change in glucose measured in blood

    Time frame: Baseline to day 15

    Unit of measurement - mg/dl

  25. Mean change in calcium measured in blood

    Time frame: Baseline to day 15

    Unit of measurement - mg/dl

  26. Mean change in phosphorous measured in blood

    Time frame: Baseline to day 15

    Unit of measurement - mg/dl

  27. Mean change in parathyroid hormome (PTH) measured in blood

    Time frame: Baseline to day 15

    Unit of measurement - pg/mL

  28. Mean change in albumin measured in blood

    Time frame: Baseline to day 15

    Unit of measurement - pg/mL

  29. Mean change in magnesium measured in blood

    Time frame: Baseline to day 15

    Unit of measurement - mEq/L

  30. Mean change in erythrocyte sedimentation rate (ESR) measured in blood

    Time frame: Baseline to day 15

    Unit of measurement - mm/hr

  31. Mean change in fibroblast growth factor (FGF)-23 measured in blood

    Time frame: Baseline to day 15

    Unit of measurement - RU/ml

  32. Mean change in total cholesterol measured in blood

    Time frame: Baseline to day 15

    Unit of measurement - mg/dl

  33. Mean change in low density lipoprotein (LDL) measured in blood

    Time frame: Baseline to day 15

    Unit of measurement - mg/dl

  34. Mean change in high density lipoprotein (HDL) measured in blood

    Time frame: Baseline to day 15

    Unit of measurement - mg/dl

  35. Mean change in triglycerides measured in blood

    Time frame: Baseline to day 15

    Unit of measurement - mg/dl

  36. Mean change in 8-isoprostane measured in urine

    Time frame: Baseline to day 15

    Unit of measurement - (ng/mg of creat)/kg

  37. Mean change in symptoms

    Time frame: Baseline to day 15

    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.

  38. Mean change in effects of kidney disease

    Time frame: Baseline to day 15

    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.

  39. Mean change in burden of kidney disease

    Time frame: Baseline to day 15

    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).

  40. Mean change in Medical Outcomes Study Short Form (MOS SF-12) physical composite

    Time frame: Baseline to day 15

    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.

  41. Mean change in Medical Outcomes Study Short Form (MOS SF-12) mental composite

    Time frame: Baseline to day 15

    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.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • Rochester Lifestyle Medicine Institute

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 2, 2024
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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