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Active, Not Recruiting

NCT Number: NCT06186843

Plant-based Diet for 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Plant-based diet

Behavioral

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.

Primary outcomes

  1. Th17/ Treg ratio

    Time frame: Baseline, week 10, 18, 26

    Th17/Treg cell ratio in peripheral blood. Results expressed as cell frequencies

  2. hsCRP

    Time frame: Baseline, week 10, 18, 26

    Plasma levels measured using enzyme-linked immunosorbent assay (ELISA) expressed as units/ mL

  3. 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

  4. Weight

    Time frame: Baseline, week 10, 18, 26

    Kilograms

  5. 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

  6. Anthropometry

    Time frame: Baseline, week 18, 26

    Mid arm and abdominal circumference will be measured in centimeters

  7. Blood pressure

    Time frame: Baseline, week 10, 18, 26

    Systolic blood pressure (mmHg)/ Diastolic blood pressure (mmHg)

  8. HbA1c

    Time frame: Baseline, week 10, 18, 26

    mmol/mol and percent (percent of total hemoglobin)

  9. Non-fasting blood glucose

    Time frame: Baseline, week 10, 18, 26

    mg/dL

  10. Total cholesterol

    Time frame: Baseline, week 10, 18, 26

    mg/dL

  11. Food frequency questionnaire

    Time frame: Baseline, week 18, 26

    Nutrient intake and physical activity levels will be calculated

  12. 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

Secondary outcomes

  1. Estimated glomerular filtration rate

    Time frame: Baseline, week 10, 18, 26

    mL/min/1.73m^2

  2. Creatinine

    Time frame: Baseline, week 10, 18, 26

    mg/dL

  3. 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

  4. 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

  5. Low-density lipoprotein (LDL) cholesterol

    Time frame: Baseline, week 10, 18, 26

    mg/dL

  6. High-density lipoprotein (HDL) cholesterol

    Time frame: Baseline, week 10, 18, 26

    mg/dL

  7. Triglycerides

    Time frame: Baseline, week 10, 18, 26

    mg/dL

Other outcomes

  1. Blood electrolytes (Na, K, Cl, Ca, Phosphorous)

    Time frame: Baseline, week 10, 18, 26

    mEq/L

  2. Urine protein

    Time frame: Baseline, week 10, 18, 26

    mg/L

  3. Urine albumin

    Time frame: Baseline, week 10, 18, 26

    mg/L

  4. Urine electrolytes (Na, K, Cl, Ca, Phosphorous)

    Time frame: Baseline, week 10, 18, 26

    mEq/L

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 2, 2024
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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