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Kidney Transplant; ComplicationsNCT05449496

Dietary Intervention to Improve Kidney Transplant Outcomes

A study testing Dietary Education Curriculum in people with Kidney Transplant; Complications and Kidney Diseases, run by University of California, Davis at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Randomized controlled trial of a curriculum intervention teaching patients to eat a whole-food plant-based dietary pattern versus standard of care in kidney transplant recipients within the first few months of transplant Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Dietary Education Curriculum
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
1 siteUnited States
Study dates
27 Jun 2022to 1 Jul 2028
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Kidney transplant recipient aged 18 or greater
  • Post-transplant months 2-12
  • eGFR >= 20 mL/min
  • Have at least one of the following:
  • Hypertension history (BP >= 150/90 or on BP medications)
  • Hyperglycemia history (FBG >= 100 x 2 or on diabetes medications)
  • Overweight (BMI >= 25)

Who cannot join

  • Rejection episode before study enrollment
  • Gastrointestinal feeding tube or requires alternative nutrition
  • Unable to understand or read English
  • Unable to attend online classes or complete study questionnaires independently
  • Already eating a plant-based diet
  • Unwilling to make dietary changes
Show all 10Show fewer
  • Pregnant or breastfeeding
  • Unable to consent
  • Blindness
  • Prisoners

Trial locations and contacts

1 site in 1 country.

United States1 site
  • UC Davis

    Sacramento, California, 95817

Other trials in United States

About this study

Randomized controlled trial of a curriculum intervention teaching patients to eat a whole-food plant-based dietary pattern versus standard of care in kidney transplant recipients within the first few months of transplant

Read the detailed description

A whole-food plant-based dietary pattern has emerged as fundamental in preventing and treating many of the lifestyle-related diseases of Western medicine, including cardiovascular disease, diabetes, hyperlipidemia, obesity, hypertension, chronic kidney disease and certain cancers. These diseases often occur or recur in the post-transplant population, leading to patient and graft loss. However, dietary education for kidney transplant recipients is not standardized and many patients remain ignorant about optimum healthy dietary practices. These patients are further challenged by the common occurrence of electrolyte derangements that require dietary restrictions. We propose a randomized controlled trial of a dietary intervention that focuses on whole-food plant-based eating in the kidney transplant population, testing this dietary pattern's impact on recipient health outcomes. This study addresses the critical need for cost-effective and safe strategies to improve health outcomes in transplant recipients and preserve kidney graft function. We have assembled an interdisciplinary team with expertise in transplant nephrology, lifestyle medicine, plant-based renal nutrition, health coaching and biostatistics to investigate the following aims: (1) to test the efficacy of a whole-food plant-based diet on improving kidney recipient cardiovascular and metabolic health and kidney allograft function, (2) to test the effect of a whole-food plant-based diet on kidney recipient post-transplant complication rates, and (3) to test the feasibility of a dietary education program on kidney transplant recipients' ability to adhere to a whole-food plant-based diet, all within a 12-month randomized controlled trial of plant-based diet versus usual care. Dietary counseling will focus on eating a predominantly plant-based diet comprised of fruits, vegetables, whole grains and legumes, and low in animal products, fats and processed foods. Dietary counseling will occur in group-based sessions weekly for the first month, then biweekly for 5 months. Patients will be followed for 12 months. This study has the potential to establish dietary intervention as a way to prolong kidney graft survival and to improve overall health and survival in kidney transplant recipients. This study will also launch a cohort of patients whose dietary patterns can be followed and compared over time, providing groundwork for further research into the connections between diet and kidney-related outcomes.

Being tested
Dietary Education Curriculum
Keywords
diet
Medical subject headings
Kidney Diseases, Diabetes Mellitus, Hypertension, Obesity

What participants receive

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

  • Dietary Education CurriculumBehavioural

    Curriculum of dietary education and group-based counseling to encourage whole-food plant-based eating

Study groups in NCT05449496
Study groupRoleWhat they receive
ControlNo interventionNot described
InterventionExperimentalNot described
Receives: Behavioral: Dietary Education Curriculum

What is being measured

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

  1. Cardiometabolic health measures

    Proportion of individuals achieving normotension, normoglycemia and weight reduction

    Measured: 1 year

  2. Post-transplant complications rates

    Composite incidence of emergency medical visits, hospitalizations and infections

    Measured: 1 year

Secondary outcomes (1)
  1. Dietary complications

    Incidence of diarrhea, use of electrolyte correcting medications, severity of hyper- and hypoglycemic events

    Measured: 1 year

Timeline

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

  1. First posted8 Jul 2022
  2. Study start27 Jun 2022
  3. Primary completion1 Jul 2028 (estimated)
  4. Study completion1 Jul 2028 (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
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05449496
Sponsor's protocol ID
1771192
Status last verified
Apr 2026
First submitted
5 Jul 2022
Last updated
8 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Dietary Education Curriculum in people with Kidney Transplant; Complications and Kidney Diseases, run by University of California, Davis 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 10 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: under way, not looking for participants, as of the sponsor's last update on 8 Apr 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiometabolic health measures (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 8 Apr 2026.

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