Image

Plant-based Diet for Kidney Transplant Recipients

Plant-based Diet for Kidney Transplant Recipients

Non Recruiting
18-80 years
All
Phase N/A

Powered by AI

Overview

The goal of this clinical trial is to evaluate cardiometabolic and inflammatory parameters in kidney transplant recipients after transitioning to a plant-based diet (PBD). The main aims of the study are as follows:

  • To test the feasibility of transiting renal allograft recipients who are > 3 months post-transplant to a PBD
  • To study the effect of a PBD on cardiometabolic parameters in kidney transplant recipients
  • To assess the effect of a PBD on peripheral blood Th17/Treg ratio and systemic inflammation in kidney transplant recipients

Participants will be asked to:

  • Complete a 2-week investigator-designed PBD transition program
  • Follow a PBD for a minimum of 16 weeks
  • Consent for blood draws, urine samples, and fecal samples along with physical exams
  • Complete intermittent food frequency questionnaires and quality of life questionnaires
  • Periodically meet with investigators and other study participants

Researchers will compare baseline measurements with future measurements for each participant.

Description

Patients will initially be identified through electronic medical record screening.

Eligible patients will be approached in clinic and informed about the study. Patients who agree to participate will sign the informed consent document to complete enrollment.

Phase 1: Dietary Training (weeks 1-2). Patients receive instruction from a Nephrologist, who is experienced in PBDs and medical student investigators about transitioning to a plant-based diet. Patients will complete a 2 week training program consisting of presentations, videos, informational documents, and group sessions. The program is designed such that at the 2 week point, participants will feel comfortable purchasing, cooking, and eating plant-based foods.

Phase 2: Intervention (weeks 3-18). Patients will consume a PBD under supervision for 16 weeks. Each participant will receive weekly phone calls from the study team and there will be monthly large in-person group sessions.

During Phase 2, there will be an optional, but highly recommended, in person group session that occurs every month. These sessions are designed to facilitate conversations and connections between participants. The sessions will help create a sense of community amongst participants. The group sessions will entail answering participants' questions, having discussions about challenges, and breakout groups will be used so participants can talk in a smaller group environment.

Phase 3: Unsupervised PBD (weeks 19-26). Patients will continue to be followed without dietary supervision.

Dietary compliance will be assessed via food frequency questionnaires (Nutrition Quest) at baseline and weeks 18 and 26. In addition, weekly 1 day food recalls will be collected from participants.

All participants will undergo physical examination at baseline and assessment of interval medical history, medication reconciliation, clinical examination, anthropometric studies (Body mass index (BMI), abdominal circumference and mid-arm circumference) at baseline and weeks 18 and 26 of the study.

Blood, urine, and stool samples will be collected and analyzed at baseline and weeks 10, 18 and 26 of the study.

Two 5 mL vials of blood will be drawn per visit (10 mL) (at baseline, 10, 18, 26 weeks). 40 mL of blood total throughout the study.

Per visit, one 5 mL vial of blood will be used for peripheral blood mononuclear cell (PBMC) prep for flow cytometry. The other 5 mL vial of blood will be used for enzyme-linked immunoassay (ELISA).

30-50 mL of urine will be collected at each visit and processed for urinalysis.

Stool samples will be used to evaluate the composition of the gastrointestinal microbiome.

Eligibility

Inclusion Criteria:

  • > 3 months post-kidney transplant
  • On style immunosuppressive medication
  • Without evidence of active infection/ inflammatory conditions
  • Estimated glomerular filtration rate > 45ml/min/1.73 m^2
  • English speaking
  • Reliable internet access

Exclusion Criteria:

  • Acute/ chronic allograft rejection
  • History of non-compliance
  • Advance heart failure
  • Liver disease
  • Pregnancy
  • Malignancy
  • Chronic Infection
  • Currently following a plant-based diet

Study details
    Kidney Disease
    Chronic
    Transplant Complication
    Hypertension
    Diabetes Mellitus
    Metabolic Syndrome
    Inflammation
    Kidney Transplant Failure
    Dietary Habits

NCT06186843

George Washington University

21 October 2025

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.