Plant-based Diet for Kidney Transplant Recipients

May 20, 2026 updated by: Muralidharan Jagadeesan, George Washington University

Effect of Plant-based Diet on Cardiometabolic and Inflammatory Parameters in Kidney Transplant Recipients

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20037
        • Transplant Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Plant-based diet
The group will follow a plant-based diet. Compliance will be checked with dietary questionnaires.
Behavioral: Plant-based diet
A two week training program will be completed which consists of information, resources and activities that will help participants transition to a plant-based diet. Each day of the program, participants will engage with material that provides information about how a plant-based diet can improve health outcomes, how to cook plant-based meals, what to shop for when eating plant-based, and other information that will help participants become comfortable with this dietary change. In addition, each participant will have a virtual, weekly check-in with one of the investigators. Finally, participants will be encouraged to attend a once monthly group session with all participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Th17/ Treg ratio
Time Frame: Baseline, week 10, 18, 26
Th17/Treg cell ratio in peripheral blood. Results expressed as cell frequencies
Baseline, week 10, 18, 26
hsCRP
Time Frame: Baseline, week 10, 18, 26
Plasma levels measured using enzyme-linked immunosorbent assay (ELISA) expressed as units/ mL
Baseline, week 10, 18, 26
Interleukin (IL) Levels (IL-6, IL-17, IL-21)
Time Frame: Baseline, week 10, 18, 26
Plasma levels measured using ELISA expressed as units/ mL
Baseline, week 10, 18, 26
Weight
Time Frame: Baseline, week 10, 18, 26
Kilograms
Baseline, week 10, 18, 26
BMI
Time Frame: Baseline, week 10, 18, 26
Weight in kilograms (kg) and height (m) in meters will be combined to report BMI kg/m^2
Baseline, week 10, 18, 26
Anthropometry
Time Frame: Baseline, week 18, 26
Mid arm and abdominal circumference will be measured in centimeters
Baseline, week 18, 26
Blood pressure
Time Frame: Baseline, week 10, 18, 26
Systolic blood pressure (mmHg)/ Diastolic blood pressure (mmHg)
Baseline, week 10, 18, 26
HbA1c
Time Frame: Baseline, week 10, 18, 26
mmol/mol and percent (percent of total hemoglobin)
Baseline, week 10, 18, 26
Non-fasting blood glucose
Time Frame: Baseline, week 10, 18, 26
mg/dL
Baseline, week 10, 18, 26
Total cholesterol
Time Frame: Baseline, week 10, 18, 26
mg/dL
Baseline, week 10, 18, 26
Food frequency questionnaire
Time Frame: Baseline, week 18, 26
Nutrient intake and physical activity levels will be calculated
Baseline, week 18, 26
Weekly one day food recall
Time Frame: Once per week at baseline and weeks 3-18
Dietary compliance will be measured with weekly one day food recall. The percentage of total daily food that is whole food plant-based will be calculated
Once per week at baseline and weeks 3-18

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimated glomerular filtration rate
Time Frame: Baseline, week 10, 18, 26
mL/min/1.73m^2
Baseline, week 10, 18, 26
Creatinine
Time Frame: Baseline, week 10, 18, 26
mg/dL
Baseline, week 10, 18, 26
Kidney disease and quality of life (KDQOL-36)
Time Frame: Baseline, week 18, 26
Questions are divided into 5 categories (symptom/problem list; effect of kidney disease; burden of kidney disease; physical health composite; mental health composite). Each category is evaluated on a scale from 0 - 100. Higher scores indicate better outcomes
Baseline, week 18, 26
Changes in gut microbiome
Time Frame: Baseline, week 18, 26
Stool samples collected at pre-specified time points and analyzed by metagenomics for gut microbiome profile
Baseline, week 18, 26
Low-density lipoprotein (LDL) cholesterol
Time Frame: Baseline, week 10, 18, 26
mg/dL
Baseline, week 10, 18, 26
High-density lipoprotein (HDL) cholesterol
Time Frame: Baseline, week 10, 18, 26
mg/dL
Baseline, week 10, 18, 26
Triglycerides
Time Frame: Baseline, week 10, 18, 26
mg/dL
Baseline, week 10, 18, 26

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood electrolytes (Na, K, Cl, Ca, Phosphorous)
Time Frame: Baseline, week 10, 18, 26
mEq/L
Baseline, week 10, 18, 26
Urine protein
Time Frame: Baseline, week 10, 18, 26
mg/L
Baseline, week 10, 18, 26
Urine albumin
Time Frame: Baseline, week 10, 18, 26
mg/L
Baseline, week 10, 18, 26
Urine electrolytes (Na, K, Cl, Ca, Phosphorous)
Time Frame: Baseline, week 10, 18, 26
mEq/L
Baseline, week 10, 18, 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

George Washington University

Investigators

  • Principal Investigator: Muralidharan Jagadeesan, MD, George Washington University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 29, 2024

Primary Completion (Estimated)

March 25, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

October 18, 2023

First Submitted That Met QC Criteria

December 15, 2023

First Posted (Actual)

January 2, 2024

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KTX-PBD-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The details of the plan are still being decided.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Inflammation

Clinical Trials on Plant-based diet

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe