NCT07759401Not yet recruiting
Food As Medicine to Reduce CKD Burden in Health Disparity Populations
Source: ClinicalTrials.gov · Last updated 12 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- First submitted
- 20 Jul 2026
- Start date
- Oct 2026
- Primary completion date
- Oct 2031
- Lead sponsor
- University of Texas Southwestern Medical Center
- Diseases
- Chronic kidney disease
- NCT number
- NCT07759401
What you commit to
- Study type: Interventional
- Planned participants: 500
- From Oct 2026 to the primary completion date, Oct 2031
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- currently receiving dialysis or need dialysis,
- have received or need a kidney transplant,
Lab values
- 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,
- CKD stage 5 demonstrated by elevated estimated glomerular filtration rate (eGFR) obtained during baseline measures.
Other
- whose urine dipstick does not indicate micro- or macro-albuminuria (ACR \<30 mg/g),
- pregnant or plan to become pregnant in the next 12 months,
- urine ACR values indicate nephrotic proteinuria, and
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Brother Bill's Helping Hand Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| University of Texas, Southwestern Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.