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Not Yet Recruiting NCT07759401

Food As Medicine to Reduce CKD Burden in Health Disparity Populations

Conditions: Chronic Kidney Disease

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 500
Sponsor: University of Texas Southwestern Medical Center

Location: Brother Bill's Helping Hand Dallas Texas

Summary

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.

Eligibility Criteria

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 \ 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07759401). StuddyBuddy aggregates publicly available trial information.