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Chronic Kidney DiseaseVETCKDNCT07793591

Veteran Centered Meal Intervention in Chronic Kidney Disease

A study testing Medically tailored meals (MTMs) in people with Chronic Kidney Disease, run by VA Office of Research and Development at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study will study if medically tailored meals can improve health and well-being among Veterans with kidney disease. Participants will be randomly assigned to receive either medically tailored meals or usual care (wait-list control) for 3 months, followed by follow-up/crossover period. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Chronic Kidney Disease
What is being tested?
Medically tailored meals (MTMs)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
1 Oct 2027to 31 Aug 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Veteran enrolled in the Veterans Health Administration
  • Stage 3b or stage 4 Chronic Kidney Disease (CKD) ((estimated glomerular filtration rate (eGFR) 15-44 milliliter (mL)/minute/1.73 square meter (m²))
  • Systolic blood pressure 140-160 mmHg (millimeters of mercury); with a ± 5 mmHg tolerance range
  • Body mass index (BMI) between 18.5 and 40.0 kilogram (kg)/square meter (m²)
  • Able and willing to provide informed consent
  • Able and willing to participate in study visits and study procedures
  • Able to receive medically tailored meal deliveries within the study service area

Who cannot join

  • Inability to communicate in English or severe hearing impairment either, preventing study participation
  • Participation in a medically tailored meal program within the previous 6 months
  • Diagnosis of heart failure
  • Major active gastrointestinal disorder that would interfere with participation or nutritional management
  • Active cancer treatment (chemotherapy) or anticipated treatment within the next 12 months
  • Pregnancy
Show all 11Show fewer
  • Current homelessness preventing meal delivery
  • Active substance use disorder not in remission
  • Active psychosis or another condition that would impair participation
  • Terminal illness or life expectancy less than 12 months
  • Any other medical, psychiatric, or social condition that, in the opinion of the investigators, would make participation unsafe or interfere with completion of the study

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Luis M Perez, PhD RD contact

(720) 467-0757

luis.perez2@va.gov

Maryam I Nuriyeva, MPH contact

(720) 857-2712

Maryam.Nuriyeva@va.gov

United States1 site

  • Rocky Mountain Regional VA Medical Center, Aurora, CO

    Aurora, Colorado, 80045-7211

    Luis M Perez, PhD RD, (720) 467-0757, luis.perez2@va.gov

    Maryam I Nuriyeva, MPH, (720) 857-2712, Maryam.Nuriyeva@va.gov

Other trials in United States

About this study

Official title: A Veteran-Centered Medically Tailored Meal Intervention to Improve Clinical and Patient Reported Outcomes in Chronic Kidney Disease (VETCKD)

This study will study if medically tailored meals can improve health and well-being among Veterans with kidney disease. Participants will be randomly assigned to receive either medically tailored meals or usual care (wait-list control) for 3 months, followed by follow-up/crossover period. The study will evaluate blood pressure, kidney health, diet, quality of life, and other health outcomes, as well as the feasibility and acceptability of providing medically tailored meals to Veterans with kidney disease.

Read the detailed description

This pilot randomized clinical trial will evaluate the feasibility, acceptability, and preliminary effects of medically tailored meals among Veterans with chronic kidney disease. Approximately 100 Veterans with stage 3b or 4 chronic kidney disease and elevated systolic blood pressure will be enrolled and randomized 1:1 to receive medically tailored meals or usual care during an initial 3-month intervention period. Participants initially assigned to usual care will subsequently receive medically tailored meals during a 3-month crossover period. All participants will be followed for 6 months.

The medically tailored meal intervention will provide prepared meals designed to support dietary recommendations for chronic kidney disease and cardiovascular health. The study will assess intervention feasibility and acceptability, including recruitment, adherence, retention, completion of study assessments, and participant experiences with the meals.

Clinical outcomes will include systolic blood pressure, kidney function and injury measures, cardiometabolic laboratory markers, and vascular function. Dietary intake and diet quality will be assessed using 24-hour dietary recalls. Patient-reported and behavioral outcomes will include kidney disease-related quality of life, general health and well-being, treatment burden, and measures related to dietary behavior and self-management. Healthcare utilization and medication use will also be evaluated. Assessments will generally occur at baseline, 3 months, and 6 months.

Being tested
Medically tailored meals (MTMs)
Keywords
medically tailored meals, chronic kidney disease, hypertension, nutrition, diet, Veterans
Medical subject headings
Renal Insufficiency, Chronic, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medically tailored meals (MTMs)Other

    Also called MTM

    Medically tailored meals are prepared to support dietary recommendations for chronic kidney disease and cardiovascular health while considering individual dietary needs and preferences. The intervention also included nutrition education and study-related dietary support.

Study groups in NCT07793591
Study groupRoleWhat they receive
Medically tailored mealsExperimentalParticipants randomized to this arm will receive medically tailored meals for 3 months in addition to usual clinical care. Meals will be designed to support dietary recommendations for chronic kidney disease, kidney and cardiovascular health. Participants will also receive nutrition education and study-related dietary support.
Receives: Other: Medically tailored meals (MTMs)
Wait-list controlOtherParticipants randomized to this arm will continue usual clinical care without study-provided medically tailored meals during the initial 3-month randomized period. After completing the 3-month assessment, participants will cross over to receive the medically tailored meals intervention for 3 months.
Receives: Other: Medically tailored meals (MTMs)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Systolic blood pressure (SBP)

    Change in systolic blood pressure (SBP), measured in mmHg, from baseline to the 3-month assessment.

    Measured: 3 months

Secondary outcomes (2)

  1. Urine albumin-to-creatinine ratio (UACR)

    Change in urine albumin-to-creatinine ratio (UACR; milligrams/gram) from baseline to 3 months, measured using urine laboratory testing through the VA clinical laboratory.

    Measured: 3 months

  2. Estimated glomerular filtration rate (eGFR)

    Change in estimated glomerular filtration rate (eGFR; milliliter/minute/1.73^square meter) from baseline to 3 months, based on serum creatinine OR cystatin C, measured through the VA clinical laboratory.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2026
  2. Study start1 Oct 2027 (estimated)
  3. Primary completion31 May 2030 (estimated)
  4. Study completion31 Aug 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomized 1:1 to the medically tailored meal intervention or wait-list control group and followed in parallel.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07793591
Sponsor's protocol ID
NEPH-008-26S
Other IDs
1IK2RD002463
Acronym
VETCKD
Status last verified
Aug 2026
First submitted
18 Aug 2026
Last updated
3 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Perez LM, Ujano-De Motta L, Johnson-Koenke R, Jani A, Ikizler TA, Raghavan S, Leonard C, Jones CD. A Qualitative Study to Investigate the Nutrition Perspectives and Experiences of Veterans with CKD. Clin J Am Soc Nephrol. 2025 Nov 1;20(11):1503-1515. doi: 10.2215/CJN.0000000800. Epub 2025 Aug 8.

    PubMed 40779332

  • Perez L, Gendelman S, Kendrick J. Home-Delivered Medically Tailored Meal Engagement Among Hemodialysis Patients and Providers. J Ren Nutr. 2024 Jan;34(1):40-46. doi: 10.1053/j.jrn.2023.08.011. Epub 2023 Aug 26.

    PubMed 37640277

  • Perez LM, Biruete A, Wilund KR. Home-delivered meals as an adjuvant to improve volume overload and clinical outcomes in hemodialysis. Clin Kidney J. 2022 Apr 19;15(10):1829-1837. doi: 10.1093/ckj/sfac102. eCollection 2022 Oct.

    PubMed 36158146

Questions about this trial

What is this clinical trial studying?

A study testing Medically tailored meals (MTMs) in people with Chronic Kidney Disease, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Luis M Perez, PhD RD ((720) 467-0757, luis.perez2@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Systolic blood pressure (SBP) (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07793591, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.

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