Image

Dietary Intervention to Improve Kidney Transplant Outcomes

Dietary Intervention to Improve Kidney Transplant Outcomes

Recruiting
18 years and older
All
Phase N/A

Powered by AI

Overview

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

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.

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  • Pregnant or breastfeeding
  • Unable to consent
  • Blindness
  • Prisoners

Study details
    Kidney Transplant; Complications
    Kidney Diseases
    Transplant;Failure
    Kidney
    Diabetes
    Hypertension
    Obesity
    Diet
    Healthy
    Lifestyle
    Healthy

NCT05449496

University of California, Davis

23 August 2025

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.