Plant-based Diet for Kidney Transplant Recipients

George Washington University (GW)

Status: Enrolling

Conditions: Hypertension; Dietary Habits; Inflammation; Kidney Transplant Failure; Diabetes Mellitus; Transplant Complication; Metabolic Syndrome; Kidney Disease, Chronic

Treatments: Behavioral: Plant-based diet

Study type: Interventional

Funder types: Other

Identifiers

NCT06186843

KTX-PBD-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Plant-based diet

Experimental group

Description:

The group will follow a plant-based diet. Compliance will be checked with dietary questionnaires.

Treatment:

Behavioral: Plant-based diet