Nutrition Support for Kidney Disease

(VETFAM Trial)

Overseen By Luis M Perez, PhD, RD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Eastern Colorado Health Care System

Disqualifiers: Stage 1-3a CKD, Stage 5 CKD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if weekly produce boxes (VET FAM Product Box) can improve health outcomes for Veterans with specific kidney problems who face challenges in obtaining nutritious food. Participants will receive fresh fruits and vegetables, along with educational materials to maximize the benefits of these foods. Veterans with stage 3b or 4 chronic kidney disease who struggle to access nutritious food may be suitable candidates for this study. As an unphased trial, this study provides Veterans the opportunity to contribute to important research that could enhance their health and access to nutritious food.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the VET FAM Product Box is safe for Veterans with kidney disease?

Research is exploring the use of produce boxes as part of a treatment plan for Veterans with kidney disease. This plan provides fresh and canned fruits and vegetables, along with nutrition education, to help improve health.

Specific data on the safety of this approach is not yet available, as it is new and still under testing. However, the concept of using food to support health, known as "Food as Medicine," is generally well-accepted. It emphasizes improving diet and nutrition, which is typically safe for most people.

As this trial is in the early stages, detailed reports on side effects are not yet available. Generally, dietary changes, especially with guidance and support, are considered low-risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the VET FAM Product Box for kidney disease because it offers a fresh approach by integrating nutrition directly into patient care. Unlike traditional treatments that focus on medication management and dialysis, this intervention provides patients with fresh and canned fruits and vegetables, aiming to improve health through diet. By also offering nutrition education and support, it empowers patients to make healthier food choices, potentially slowing disease progression. This holistic method of combining food and education is a promising shift in managing kidney disease stages 3b-4.

What evidence suggests that the VET FAM Product Box is effective for improving outcomes in Veterans with kidney disease?

Research has shown that dietary changes can benefit people with kidney disease. Studies have found that increasing fruit and vegetable intake can improve health for those with stage 3-4 chronic kidney disease (CKD). Specifically, these dietary changes can reduce levels of waste products in the blood, key indicators of kidney health. This trial will offer participants the VET FAM Product Box and nutrition education to support these dietary changes. Access to fresh produce and nutrition education may help individuals with limited access to healthy food maintain better kidney health. ^{1 2 6 7 8}

Who Is on the Research Team?

Luis M Perez, PhD, RD

Principal Investigator

US Department of Veterans Affairs

Are You a Good Fit for This Trial?

This trial is for Veterans aged 18+ with moderate to severe kidney disease (stages 3b or 4) who are also dealing with food or nutrition insecurity. Participants must be receiving care at the VA within the Food Bank of the Rockies area and able to consent in English. Those already in a dietary study or with very mild (stage 1-3a) or advanced kidney disease requiring dialysis/transplant are excluded.

Inclusion Criteria

Positive screen for nutrition insecurity (e.g., Tufts screener)

Receiving care at the VA and residing in Food Bank of the Rockies service area

I am 18 years old or older.

Exclusion Criteria

Currently enrolled in a conflicting dietary trial

Unwilling or unable to provide informed consent

My kidney disease is in stage 1-3a or stage 5.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Veterans receive weekly produce boxes and nutrition education materials to improve dietary adherence and kidney health

6 months

Weekly produce box delivery

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• VET FAM Product Box

Trial Overview The VET FAM Product Box, which includes fresh produce, along with Nutrition Education, is being tested to see if it can improve health outcomes for Veterans with kidney issues. The study will also gather participants' feedback on their experiences through interviews.

How Is the Trial Designed?

Group I: VET FAM Product Box and Nutrition Education Experimental Treatment 1 Intervention

Veterans with kidney disease stages 3b-4 will receive weekly produce boxes through the Food Bank of the Rockies Food for Health program. Boxes include fresh/canned fruits, vegetables, and other items. Participants will also receive nutrition education materials and brief support to encourage preparation and consumption of the provided foods over the study period.

Who Is Running the Clinical Trial?

VA Eastern Colorado Health Care System

Lead Sponsor

Trials

55

Recruited

26,200+

Food Bank of the Rockies

Collaborator

National Kidney Foundation, United States

Collaborator

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07194733

Supporting VETerans With Kidney Disease Through Food ... Veterans with kidney disease stages 3b-4 will receive weekly produce boxes through the Food Bank of the Rockies Food for Health program. Boxes include fresh/ ...

2. withpower.com withpower.com/trial/phase-kidney-diseases-9-2025-704f2

Nutrition Support for Kidney Disease (VETFAM Trial) This trial is for Veterans aged 18+ with moderate to severe kidney disease (stages 3b or 4) who are also dealing with food or nutrition insecurity. Participants ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/21195912/

Benefits in nutritional interventions in patients with CKD ... However, several studies have clearly demonstrated the beneficial effects of such diets on the outcome of patients with stage 3-4 CKD. This point has been ...

4. mdpi.com mdpi.com/2308-3417/7/4/83

Nutritional Intervention Effectiveness on Slowing Time to ... Our results from this study showed that nutritional intervention decreased BUN and serum creatinine levels in CKD patients. This could be attributed to improved ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05047263

Study Details | NCT05047263 | A Trial to Learn How Well ... The trial treatment, finerenone, is being developed to help people who have long lasting kidney disease, also known as chronic kidney disease (CKD).

6. vet.uga.edu vet.uga.edu/wp-content/uploads/2023/03/Combined.Speaker.Notes_.2023.Conference.pdf

UPDATE ON MANAGING CHRONIC KIDNEY DISEASE NEW TRICKS FOR OLD KIDNEYS: UPDATE ON MANAGING CHRONIC KIDNEY DISEASE. Joe Bartges, DVM, PhD, DACVIM (SAIM, N), ACVNU (founding member).

7. journals.sagepub.com journals.sagepub.com/doi/10.1177/1098612X241283355

Dietary phosphorus and renal disease in cats: where are we? High dietary phosphorus may cause kidney damage in otherwise healthy adult cats, particularly when provided in highly bioavailable forms.

8. va.gov va.gov/health-care/about-va-health-benefits/

About VA Health Benefits | Veterans Affairs Each Veteran's medical benefits package is unique. Yours will include care and services to help: Treat illnesses and injuries; Prevent future ...