Not Yet RecruitingNot Applicable

Food As Medicine to Reduce CKD Burden in Health Disparity Populations

United States500 participantsStarted 2026-10

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Baseline (enrollment), 6 months

Change in Urine Albumin to Creatinine Ratio at 12 months

Timeframe: Baseline (enrollment), 12 months

Trial details

NCT IDNCT07759401

SponsorUniversity of Texas Southwestern Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2031-10

Contact for this trial

Emilie Ruiz, BS

469-285-6848 emilie.ruiz@utsouthwestern.edu

View on ClinicalTrials.gov More Chronic Kidney Disease trials