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

Browse trials for

• Kidney Diseases 3,840
• Renal Insufficiency, Chronic 3,144

Keywords

• Diet
• Plant-based
• Whole food
• Hypertension
• Hyperkalemia
• Blood pressure
• Potassium
• Systolic blood pressure
• Diastolic blood pressure

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 43 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Lead sponsor

University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.

Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.

Study arms

• Experimental
  Jumpstart Educational Program

  Jumpstart sessions on day 1, 2, 5, 8, 12, and 15. Tests at baseline and week 2 visit: blood pressure, height and weight measurements to calculate a body mass index, urine tests to assess antioxidant activity, quality of life questionnaire (\~8 minutes to complete) about physical and mental symptoms, a 3-day food record to assess if participants are changing their diet over the course of the study, assessment of medication use. Tests performed at day 1, day 8, and day 15: A small blood draw \[about 1 teaspoon\] to check chemistry levels, cholesterol, and markers of inflammation. Laboratory tests are reviewed once available, and participant contacted by the study team either by telephone or My Chart regarding clinically significant results that require intervention. If potassium levels are higher than 5.2 Meq/L, the study team contacts the participant or their alternate contact directly. For the intervention group, this is in addition to the finger-stick blood collection.

  Behavioral: Dietary education program

• No intervention
  Control group

  Participants randomized to the control group continue to receive medical, dietary, and nutritional advice from their medical team as normal. The testing is the same testing as the intervention group and will be done at day 1, day 8, and day 15 of the study. They do not participate in the educational sessions during the study but will have the opportunity to participate in the program at no charge at the conclusion of the study.

Interventions

• BehavioralDietary education program

  Jumpstart educational program: https://www.rochesterlifestylemedicine.com/about-community-jumpstart/

  Also known as: Nutritional education program

Primary outcomes

1. Mean change in systolic blood pressure

   Unit of measurement - mm Hg

   Time frame: Baseline to day 15

2. Mean change in diastolic blood pressure

   Unit of measurement - mm Hg

   Time frame: Baseline to day 15

3. Mean change in potassium levels

   Unit of measurement - mEq/L

   Time frame: Baseline to day 15

4. Proportion of participants developing hyperkalemia

   Percentage

   Time frame: Day 15

Secondary outcomes

1. 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.

   Time frame: Baseline to day 15

2. 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.

   Time frame: Baseline to day 15

3. 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.

   Time frame: Baseline to day 15

4. 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.

   Time frame: Baseline to day 15

5. 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.

   Time frame: Baseline to day 15

6. 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.

   Time frame: Baseline to day 15

7. 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.

   Time frame: Baseline to day 15

8. 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.

   Time frame: Baseline to day 15

9. 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.

   Time frame: Baseline to day 15

10. 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.

    Time frame: Baseline to day 15

11. 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.

    Time frame: Baseline to day 15

12. 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.

    Time frame: Baseline to day 15

13. 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.

    Time frame: Baseline to day 15

14. 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.

    Time frame: Baseline to day 15

15. 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.

    Time frame: Baseline to day 15

16. 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.

    Time frame: Baseline to day 15

17. 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.

    Time frame: Baseline to day 15

18. 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.

    Time frame: Baseline to day 15

19. Mean change in sodium measured in blood

    Unit of measurement - mEq/L

    Time frame: Baseline to day 15

20. Mean change in chloride measured in blood

    Unit of measurement - mEq/L

    Time frame: Baseline to day 15

21. Mean change in bicarbonate measured in blood

    Unit of measurement - mEq/L

    Time frame: Baseline to day 15

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

    Unit of measurement - mg/dl

    Time frame: Baseline to day 15

23. Mean change in creatinine measured in blood

    Unit of measurement - mg/dl

    Time frame: Baseline to day 15

24. Mean change in glucose measured in blood

    Unit of measurement - mg/dl

    Time frame: Baseline to day 15

25. Mean change in calcium measured in blood

    Unit of measurement - mg/dl

    Time frame: Baseline to day 15

26. Mean change in phosphorous measured in blood

    Unit of measurement - mg/dl

    Time frame: Baseline to day 15

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

    Unit of measurement - pg/mL

    Time frame: Baseline to day 15

28. Mean change in albumin measured in blood

    Unit of measurement - pg/mL

    Time frame: Baseline to day 15

29. Mean change in magnesium measured in blood

    Unit of measurement - mEq/L

    Time frame: Baseline to day 15

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

    Unit of measurement - mm/hr

    Time frame: Baseline to day 15

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

    Unit of measurement - RU/ml

    Time frame: Baseline to day 15

32. Mean change in total cholesterol measured in blood

    Unit of measurement - mg/dl

    Time frame: Baseline to day 15

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

    Unit of measurement - mg/dl

    Time frame: Baseline to day 15

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

    Unit of measurement - mg/dl

    Time frame: Baseline to day 15

35. Mean change in triglycerides measured in blood

    Unit of measurement - mg/dl

    Time frame: Baseline to day 15

36. Mean change in 8-isoprostane measured in urine

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

    Time frame: Baseline to day 15

37. 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.

    Time frame: Baseline to day 15

38. 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.

    Time frame: Baseline to day 15

39. 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).

    Time frame: Baseline to day 15

40. 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.

    Time frame: Baseline to day 15

41. 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.

    Time frame: Baseline to day 15