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

NCT ID: NCT06343129

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-26
• Study Completion Date: 2022-12-12

Brief Summary

The purpose of this study is to determine if an educational program emphasizing a whole food plant based diet favorably impacts blood pressure while not significantly increasing blood potassium levels, by comparing a group of patients receiving the educational program with a control group of patients receiving no specific education.

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:

A) To test the effect of the Jumpstart program on degree of uptake on a WFPB diet via a 3 day food recall.

B) To test the effect of the Jumpstart program on other important outcomes in CKD in the following domains:

1. Body composition such as weight and body mass index (BMI).

2. Quality of life.

3. Laboratory tests including- serum levels of sodium, bicarbonate, chloride, Blood urea nitrogen, creatinine, calcium, phosphorus, magnesium, albumin, parathyroid hormone, fibroblast growth factor 23, lipids, C-reactive protein and erythrocyte sedimentation rate.

C) To test the effect of the Jumpstart program on quality of life in hypertensive CKD patients.

Conditions

Chronic Kidney Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Dietary education program

Intervention Type: BEHAVIORAL

Jumpstart educational program:

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dietary education program

Jumpstart educational program:

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Nutritional education program

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rochester Lifestyle Medicine Institute

UNKNOWN

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Scott Liebman

Professor of Medicine, Division of Nephrology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Clinical Research Center of the University of Rochester Medical Center

Rochester, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

Countries

United States

Other Identifiers

3817

Identifier Type: -

Identifier Source: org_study_id