protocolSection identificationModule nctId: NCT06343129, orgStudyIdInfo id: 3817, briefTitle: Effects of a Whole-food, Plant-based Nutrition Program on BP and Potassium in Subjects With CKD, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-10-26, primaryCompletionDateStruct date: 2022-12-12, completionDateStruct date: 2022-12-12, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: University of Rochester, class: OTHER, collaborators name: Rochester Lifestyle Medicine Institute, descriptionModule briefSummary: 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., conditionsModule conditions: Chronic Kidney Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 43, type: ACTUAL, armsInterventionsModule interventions name: Dietary education program, outcomesModule primaryOutcomes measure: Mean change in systolic blood pressure, primaryOutcomes measure: Mean change in diastolic blood pressure, primaryOutcomes measure: Mean change in potassium levels, primaryOutcomes measure: Proportion of participants developing hyperkalemia, secondaryOutcomes measure: Mean Change in energy/day, secondaryOutcomes measure: Mean change in energy/kg of body mass, secondaryOutcomes measure: Mean change in total fat, secondaryOutcomes measure: Mean change in % calories from fat, secondaryOutcomes measure: Mean change in % calories from carbohydrates, secondaryOutcomes measure: Mean change in % calories from protein, secondaryOutcomes measure: Mean change in Animal protein, secondaryOutcomes measure: Mean change in Vegetable protein, secondaryOutcomes measure: Mean change in cholesterol, secondaryOutcomes measure: Mean change in Total dietary fiber, secondaryOutcomes measure: Mean change in Total fiber per 1000 kcal, secondaryOutcomes measure: Mean change in calcium, secondaryOutcomes measure: Mean change in phosphorous, secondaryOutcomes measure: Mean change in magnesium, secondaryOutcomes measure: Mean change in sodium, secondaryOutcomes measure: Mean change in potassium, secondaryOutcomes measure: Mean change in body mass, secondaryOutcomes measure: Mean change in body mass index, secondaryOutcomes measure: Mean change in sodium measured in blood, secondaryOutcomes measure: Mean change in chloride measured in blood, secondaryOutcomes measure: Mean change in bicarbonate measured in blood, secondaryOutcomes measure: Mean change in blood urea nitrogen (BUN) measured, secondaryOutcomes measure: Mean change in creatinine measured in blood, secondaryOutcomes measure: Mean change in glucose measured in blood, secondaryOutcomes measure: Mean change in calcium measured in blood, secondaryOutcomes measure: Mean change in phosphorous measured in blood, secondaryOutcomes measure: Mean change in parathyroid hormome (PTH) measured in blood, secondaryOutcomes measure: Mean change in albumin measured in blood, secondaryOutcomes measure: Mean change in magnesium measured in blood, secondaryOutcomes measure: Mean change in erythrocyte sedimentation rate (ESR) measured in blood, secondaryOutcomes measure: Mean change in fibroblast growth factor (FGF)-23 measured in blood, secondaryOutcomes measure: Mean change in total cholesterol measured in blood, secondaryOutcomes measure: Mean change in low density lipoprotein (LDL) measured in blood, secondaryOutcomes measure: Mean change in high density lipoprotein (HDL) measured in blood, secondaryOutcomes measure: Mean change in triglycerides measured in blood, secondaryOutcomes measure: Mean change in 8-isoprostane measured in urine, secondaryOutcomes measure: Mean change in symptoms, secondaryOutcomes measure: Mean change in effects of kidney disease, secondaryOutcomes measure: Mean change in burden of kidney disease, secondaryOutcomes measure: Mean change in Medical Outcomes Study Short Form (MOS SF-12) physical composite, secondaryOutcomes measure: Mean change in Medical Outcomes Study Short Form (MOS SF-12) mental composite, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinical Research Center of the University of Rochester Medical Center, city: Rochester, state: New York, zip: 14642, country: United States, geoPoint lat: 43.15478, lon: -77.61556, locations facility: University of Rochester Medical Center, city: Rochester, state: New York, zip: 14642, country: United States, geoPoint lat: 43.15478, lon: -77.61556, hasResults: False