Chronic Kidney DiseasesNCT06343129
Effects of a Whole-food, Plant-based Nutrition Program on BP and Potassium in Subjects With CKD
A study testing Dietary education program in people with Chronic Kidney Diseases, run by University of Rochester at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Dietary education program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Oct 2020to 12 Dec 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 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
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- 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)
Who cannot join
- 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)
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Clinical Research Center of the University of Rochester Medical Center
Rochester, New York, 14642
University of Rochester Medical Center
Rochester, New York, 14642
About this study
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
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.
Read the 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:
- To test the effect of the Jumpstart program on degree of uptake on a WFPB diet via a 3 day food recall.
- 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.
- To test the effect of the Jumpstart program on quality of life in hypertensive CKD patients.
- Conditions
- Chronic Kidney Diseases
- Being tested
- Dietary education program
- Keywords
- Diet, Plant-based, Whole food, Hypertension, Hyperkalemia, Blood pressure, Potassium, Systolic blood pressure, Diastolic blood pressure
- Medical subject headings
- Renal Insufficiency, Chronic, Hypertension, Hyperkalemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary education programBehavioural
Also called Nutritional education program
Jumpstart educational program:
https://www.rochesterlifestylemedicine.com/about-community-jumpstart/
| Study group | Role | What they receive |
|---|---|---|
| Jumpstart Educational Program | Experimental | 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. Receives: Behavioral: Dietary education program |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in systolic blood pressure
Unit of measurement - mm Hg
Measured: Baseline to day 15
Mean change in diastolic blood pressure
Unit of measurement - mm Hg
Measured: Baseline to day 15
Mean change in potassium levels
Unit of measurement - mEq/L
Measured: Baseline to day 15
Proportion of participants developing hyperkalemia
Percentage
Measured: Day 15
Secondary outcomes (41)
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.
Measured: Baseline to day 15
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.
Measured: Baseline to day 15
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.
Measured: Baseline to day 15
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.
Measured: Baseline to day 15
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.
Measured: Baseline to day 15
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.
Measured: Baseline to day 15
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.
Measured: Baseline to day 15
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.
Measured: Baseline to day 15
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.
Measured: Baseline to day 15
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.
Measured: Baseline to day 15
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.
Measured: Baseline to day 15
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.
Measured: Baseline to day 15
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.
Measured: Baseline to day 15
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.
Measured: Baseline to day 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.
Measured: Baseline to day 15
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.
Measured: Baseline to day 15
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.
Measured: Baseline to day 15
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.
Measured: Baseline to day 15
Mean change in sodium measured in blood
Unit of measurement - mEq/L
Measured: Baseline to day 15
Mean change in chloride measured in blood
Unit of measurement - mEq/L
Measured: Baseline to day 15
Mean change in bicarbonate measured in blood
Unit of measurement - mEq/L
Measured: Baseline to day 15
Mean change in blood urea nitrogen (BUN) measured
Unit of measurement - mg/dl
Measured: Baseline to day 15
Mean change in creatinine measured in blood
Unit of measurement - mg/dl
Measured: Baseline to day 15
Mean change in glucose measured in blood
Unit of measurement - mg/dl
Measured: Baseline to day 15
Mean change in calcium measured in blood
Unit of measurement - mg/dl
Measured: Baseline to day 15
Mean change in phosphorous measured in blood
Unit of measurement - mg/dl
Measured: Baseline to day 15
Mean change in parathyroid hormome (PTH) measured in blood
Unit of measurement - pg/mL
Measured: Baseline to day 15
Mean change in albumin measured in blood
Unit of measurement - pg/mL
Measured: Baseline to day 15
Mean change in magnesium measured in blood
Unit of measurement - mEq/L
Measured: Baseline to day 15
Mean change in erythrocyte sedimentation rate (ESR) measured in blood
Unit of measurement - mm/hr
Measured: Baseline to day 15
Mean change in fibroblast growth factor (FGF)-23 measured in blood
Unit of measurement - RU/ml
Measured: Baseline to day 15
Mean change in total cholesterol measured in blood
Unit of measurement - mg/dl
Measured: Baseline to day 15
Mean change in low density lipoprotein (LDL) measured in blood
Unit of measurement - mg/dl
Measured: Baseline to day 15
Mean change in high density lipoprotein (HDL) measured in blood
Unit of measurement - mg/dl
Measured: Baseline to day 15
Mean change in triglycerides measured in blood
Unit of measurement - mg/dl
Measured: Baseline to day 15
Mean change in 8-isoprostane measured in urine
Unit of measurement - (ng/mg of creat)/kg
Measured: Baseline to day 15
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.
Measured: Baseline to day 15
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.
Measured: Baseline to day 15
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).
Measured: Baseline to day 15
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.
Measured: Baseline to day 15
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.
Measured: Baseline to day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start26 Oct 2020
- Primary completion12 Dec 2022
- Study completion12 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies 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
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Rochester Lifestyle Medicine Institute
- Responsible party
- Principal investigator, Scott Liebman, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06343129
- Sponsor's protocol ID
- 3817
- Status last verified
- Apr 2024
- First submitted
- 26 Mar 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06343129
- Acronym / sponsor ID
- 3817
- Conditions
- Chronic Kidney Diseases
- Keywords
- Diet, Plant-based, Whole food, Hypertension, Hyperkalemia, Blood pressure, Potassium, Systolic blood pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Rochester Lifestyle Medicine Institute
- Study start
- 26 Oct 2020 (actual)
- Primary completion
- 12 Dec 2022 (actual)
- Study completion
- 12 Dec 2022 (actual)
- First posted
- 2 Apr 2024 (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.
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:
- To test the effect of the Jumpstart program on degree of uptake on a WFPB diet via a 3 day food recall.
- 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.
- To test the effect of the Jumpstart program on quality of life in hypertensive CKD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Jumpstart Educational Program | Experimental | Behavioral: Dietary education programJumpstart 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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (13 listed)
- 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
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 |
|---|---|---|
| Dietary education programAlso: Nutritional education programJumpstart educational program: https://www.rochesterlifestylemedicine.com/about-community-jumpstart/ | Behavioural | Jumpstart Educational Program |
Primary outcome
Mean change in systolic blood pressure
Time frame: Baseline to day 15
Unit of measurement - mm Hg
Mean change in diastolic blood pressure
Time frame: Baseline to day 15
Unit of measurement - mm Hg
Mean change in potassium levels
Time frame: Baseline to day 15
Unit of measurement - mEq/L
Proportion of participants developing hyperkalemia
Time frame: Day 15
Percentage
41 secondary outcomes
Mean Change in energy/day
Time frame: Baseline to day 15
Mean change in energy/kg of body mass
Time frame: Baseline to day 15
Mean change in total fat
Time frame: Baseline to day 15
Mean change in % calories from fat
Time frame: Baseline to day 15
Mean change in % calories from carbohydrates
Time frame: Baseline to day 15
Mean change in % calories from protein
Time frame: Baseline to day 15
Mean change in Animal protein
Time frame: Baseline to day 15
Mean change in Vegetable protein
Time frame: Baseline to day 15
Mean change in cholesterol
Time frame: Baseline to day 15
Mean change in Total dietary fiber
Time frame: Baseline to day 15
Mean change in Total fiber per 1000 kcal
Time frame: Baseline to day 15
Mean change in calcium
Time frame: Baseline to day 15
Mean change in phosphorous
Time frame: Baseline to day 15
Mean change in magnesium
Time frame: Baseline to day 15
Mean change in sodium
Time frame: Baseline to day 15
Mean change in potassium
Time frame: Baseline to day 15
Mean change in body mass
Time frame: Baseline to day 15
Mean change in body mass index
Time frame: Baseline to day 15
Mean change in sodium measured in blood
Time frame: Baseline to day 15
Mean change in chloride measured in blood
Time frame: Baseline to day 15
Mean change in bicarbonate measured in blood
Time frame: Baseline to day 15
Mean change in blood urea nitrogen (BUN) measured
Time frame: Baseline to day 15
Mean change in creatinine measured in blood
Time frame: Baseline to day 15
Mean change in glucose measured in blood
Time frame: Baseline to day 15
Mean change in calcium measured in blood
Time frame: Baseline to day 15
Mean change in phosphorous measured in blood
Time frame: Baseline to day 15
Mean change in parathyroid hormome (PTH) measured in blood
Time frame: Baseline to day 15
Mean change in albumin measured in blood
Time frame: Baseline to day 15
Mean change in magnesium measured in blood
Time frame: Baseline to day 15
Mean change in erythrocyte sedimentation rate (ESR) measured in blood
Time frame: Baseline to day 15
Mean change in fibroblast growth factor (FGF)-23 measured in blood
Time frame: Baseline to day 15
Mean change in total cholesterol measured in blood
Time frame: Baseline to day 15
Mean change in low density lipoprotein (LDL) measured in blood
Time frame: Baseline to day 15
Mean change in high density lipoprotein (HDL) measured in blood
Time frame: Baseline to day 15
Mean change in triglycerides measured in blood
Time frame: Baseline to day 15
Mean change in 8-isoprostane measured in urine
Time frame: Baseline to day 15
Mean change in symptoms
Time frame: Baseline to day 15
Mean change in effects of kidney disease
Time frame: Baseline to day 15
Mean change in burden of kidney disease
Time frame: Baseline to day 15
Mean change in Medical Outcomes Study Short Form (MOS SF-12) physical composite
Time frame: Baseline to day 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary education program in people with Chronic Kidney Diseases, run by University of Rochester at 2 sites 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 9 inclusion and 13 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: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean change in systolic blood pressure (time frame: Baseline to day 15). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2024.