Plant-based Diet for Kidney Transplant Recipients
- Conditions
- InflammationTransplant ComplicationDiabetes MellitusMetabolic SyndromeDietary HabitsKidney Disease, ChronicHypertensionKidney Transplant Failure
- Interventions
- Behavioral: Plant-based diet
- Registration Number
- NCT06186843
- Lead Sponsor
- George Washington University
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 25
- > 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
- Acute/ chronic allograft rejection
- History of non-compliance
- Advance heart failure
- Liver disease
- Pregnancy
- Malignancy
- Chronic Infection
- Currently following a plant-based diet
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Plant-based diet Plant-based diet The group will follow a plant-based diet. Compliance will be checked with dietary questionnaires.
- Primary Outcome Measures
Name Time Method Th17/ Treg ratio Baseline, week 10, 18, 26 Th17/Treg cell ratio in peripheral blood. Results expressed as cell frequencies
Interleukin (IL) Levels (IL-6, IL-17, IL-21) Baseline, week 10, 18, 26 Plasma levels measured using ELISA expressed as units/ mL
Weight Baseline, week 10, 18, 26 Kilograms
Anthropometry Baseline, week 18, 26 Mid arm and abdominal circumference will be measured in centimeters
Blood pressure Baseline, week 10, 18, 26 Systolic blood pressure (mmHg)/ Diastolic blood pressure (mmHg)
HbA1c Baseline, week 10, 18, 26 mmol/mol and percent (percent of total hemoglobin)
Non-fasting blood glucose Baseline, week 10, 18, 26 mg/dL
Total cholesterol Baseline, week 10, 18, 26 mg/dL
hsCRP Baseline, week 10, 18, 26 Plasma levels measured using enzyme-linked immunosorbent assay (ELISA) expressed as units/ mL
BMI Baseline, week 10, 18, 26 Weight in kilograms (kg) and height (m) in meters will be combined to report BMI kg/m\^2
Food frequency questionnaire Baseline, week 18, 26 Nutrient intake and physical activity levels will be calculated
Weekly one day food recall 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 Outcome Measures
Name Time Method Low-density lipoprotein (LDL) cholesterol Baseline, week 10, 18, 26 mg/dL
Creatinine Baseline, week 10, 18, 26 mg/dL
High-density lipoprotein (HDL) cholesterol Baseline, week 10, 18, 26 mg/dL
Estimated glomerular filtration rate Baseline, week 10, 18, 26 mL/min/1.73m\^2
Kidney disease and quality of life (KDQOL-36) 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
Triglycerides Baseline, week 10, 18, 26 mg/dL
Changes in gut microbiome Baseline, week 18, 26 Stool samples collected at pre-specified time points and analyzed by metagenomics for gut microbiome profile
Trial Locations
- Locations (1)
Transplant Institute
šŗšøWashington, District of Columbia, United States