Food As Medicine to Reduce CKD Burden in Health Disparity Populations

N/ANot Yet RecruitingNCT07759401

University of Texas Southwestern Medical Center500 enrolled

Overview

Healthy eating plays an important role in kidney and heart health, and programs that use food as medicine can help improve diet and overall health, but the best ways to support healthy eating in community settings are not well understood. The purpose of this study is to compare two study groups to see which is more effective at improving kidney health and related health outcomes in adults with chronic kidney disease. One group receives fruits and vegetables with cooking education, and the other receives fruits and vegetables alone. The results may help researchers develop community-based programs to improve kidney and heart health, especially in populations at higher risk for kidney disease. If the participant joins the study, the participant will complete a baseline visit, a 6-month visit, and a 12-month visit. Visits include questionnaires about the participant's health, diet, and cooking habits; a urine sample; a blood sample; blood pressure, height, weight, and waist measurements; and a brief, painless Veggie Meter® scan to measure fruit and vegetable intake. Participants will pick up weekly fruits and vegetables for 12 months. Those in the cooking group will also attend 12 weekly cooking and nutrition classes and receive follow-up newsletters and optional monthly virtual sessions. Depending on the group to which the participants are assigned, the total time commitment for the participants in this study will range from approximately 3 to 15 hours. Participation is voluntary, involves minimal risk, and all information will be kept private. Possible risks include brief pain or bruising from the blood draw, mild discomfort from urine collection, minor risk of cuts or burns during cooking, and some questions may feel personal; the participant may skip any question. There may be no direct benefit to the participant, but the participant's participation may help improve nutrition and kidney health programs in the community.

Chronic kidney disease (CKD) impacts approximately 1/7 Americans, who experience asymptomatic progressive CKD leading to catastrophic complications, including kidney failure and death, and this R01 study will extend our previous R21 work to screen, identify , and intervene with culinary medicine philosophy within a community-based setting. The overall goals of the research study are to evaluate (1) urine albumin to creatinine ratio outcomes, (2) secondary endpoints including cardiovascular disease (CVD) measurements (i.e., systolic and diastolic blood pressure, body mass index, hemoglobin A1c, lipids), and (3) dietary adherence and change as well as nutrition knowledge and efficacy. This work will determine whether base-producing fruit and vegetables with or without culinary medicine improves CKD outcomes and associated CVD risk in lower socioeconomic community settings to inform future multi-site trials and population level implementation .

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * men and women of age ≥ 18 years and able to give consent; * willingness to participate in a 12-month study; * elevated albumin to creatinine ratio (ACR) (≥ 30 mg/g) determined by point-of-care urine dipstick during health screen; * Reside in a low-income area or visit a food pantry due to food insecurity Exclusion Criteria: * whose urine dipstick does not indicate micro- or macro-albuminuria (ACR \<30 mg/g), * currently receiving dialysis or need dialysis, * have received or need a kidney transplant, * pregnant or plan to become pregnant in the next 12 months, * baseline urine potassium \> 60 mEq/g creatinine (baseline excretion below this level was not associated with hyperkalemia when fruit/vegetable were paired with kidney-protective drugs, * urine ACR values indicate nephrotic proteinuria, and * CKD stage 5 demonstrated by elevated estimated glomerular ﬁltration rate (eGFR) obtained during baseline measures.

Outcomes

Primary Outcomes

Change from Baseline in Urine Albumin to Creatinine Ratio at 6 months

Diagnostic laboratory results for urinalysis will determine whether urine albumin-to-creatinine ratio (UACR) is reduced to a greater extent with the FV + Cook intervention as compared to FV Only at 6- months. High levels of urine albumin excretion predict increased risk for subsequent eGFR decline and its change during follow up is directly associated with risk for End-Stage Kidney Disease (ESKD).

Time frame: Baseline (enrollment), 6 months

Change in Urine Albumin to Creatinine Ratio at 12 months

Diagnostic laboratory results for urinalysis will determine whether urine albumin-to-creatinine ratio (UACR) is reduced to a greater extent with the FV + Cook intervention as compared to FV Only at 12-months. High levels of urine albumin excretion predict increased risk for subsequent eGFR decline and its change during follow up is directly associated with risk for ESKD.