Plant-based Diet for Kidney Transplant Recipients

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06186843
• Other study ID #: KTX-PBD-001
• Status: Recruiting
• Phase: N/A
• Start date: February 29, 2024
• Est. completion date: March 1, 2025

Study information

• Verified date: May 2024
• Source: George Washington University
• Contact: Muralidharan Jagadeesan, MD
• Phone: 202-741-2283
• Email: mjagadeesan[@]mfa.gwu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: March 1, 2025
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Dietary Habits
• Hypertension
• Inflammation
• Kidney Disease, Chronic
• Kidney Diseases
• Kidney Transplant Failure
• Metabolic Syndrome
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
United States	Transplant Institute	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
George Washington University

Country where clinical trial is conducted

United States, 

References & Publications (18)

Abedini S, Holme I, Marz W, Weihrauch G, Fellstrom B, Jardine A, Cole E, Maes B, Neumayer HH, Gronhagen-Riska C, Ambuhl P, Holdaas H; ALERT study group. Inflammation in renal transplantation. Clin J Am Soc Nephrol. 2009 Jul;4(7):1246-54. doi: 10.2215/CJN.00930209. Epub 2009 Jun 18. — View Citation

Amdur RL, Paul R, Barrows ED, Kincaid D, Muralidharan J, Nobakht E, Centron-Vinales P, Siddiqi M, Patel SS, Raj DS. The potassium regulator patiromer affects serum and stool electrolytes in patients receiving hemodialysis. Kidney Int. 2020 Nov;98(5):1331-1340. doi: 10.1016/j.kint.2020.06.042. Epub 2020 Aug 1. — View Citation

Gao B, Alonzo-Palma N, Brooks B, Jose A, Barupal D, Jagadeesan M, Nobakht E, Collins A, Ramezani A, Omar B, Amdur RL, Raj DS. A Pilot Study on the Effect of Prebiotic on Host-Microbial Co-metabolism in Peritoneal Dialysis Patients. Kidney Int Rep. 2020 Jun 1;5(8):1309-1315. doi: 10.1016/j.ekir.2020.05.023. eCollection 2020 Aug. No abstract available. — View Citation

Goldfarb Cyrino L, Galpern J, Moore L, Borgi L, Riella LV. A Narrative Review of Dietary Approaches for Kidney Transplant Patients. Kidney Int Rep. 2021 Apr 27;6(7):1764-1774. doi: 10.1016/j.ekir.2021.04.009. eCollection 2021 Jul. — View Citation

Gutierrez OM, Muntner P, Rizk DV, McClellan WM, Warnock DG, Newby PK, Judd SE. Dietary patterns and risk of death and progression to ESRD in individuals with CKD: a cohort study. Am J Kidney Dis. 2014 Aug;64(2):204-13. doi: 10.1053/j.ajkd.2014.02.013. Epub 2014 Mar 27. — View Citation

Hill CJ, Courtney AE, Cardwell CR, Maxwell AP, Lucarelli G, Veroux M, Furriel F, Cannon RM, Hoogeveen EK, Doshi M, McCaughan JA. Recipient obesity and outcomes after kidney transplantation: a systematic review and meta-analysis. Nephrol Dial Transplant. 2015 Aug;30(8):1403-11. doi: 10.1093/ndt/gfv214. Epub 2015 Jun 4. — View Citation

Hoogeveen EK, Aalten J, Rothman KJ, Roodnat JI, Mallat MJ, Borm G, Weimar W, Hoitsma AJ, de Fijter JW. Effect of obesity on the outcome of kidney transplantation: a 20-year follow-up. Transplantation. 2011 Apr 27;91(8):869-74. doi: 10.1097/TP.0b013e3182100f3a. — View Citation

Jezior D, Krajewska M, Madziarska K, Kurc-Darak B, Janczak D, Patrzalek D, Boryslawski K, Klinger M. Posttransplant overweight and obesity: myth or reality? Transplant Proc. 2007 Nov;39(9):2772-5. doi: 10.1016/j.transproceed.2007.09.001. — View Citation

Kalantar-Zadeh K, Kopple JD, Deepak S, Block D, Block G. Food intake characteristics of hemodialysis patients as obtained by food frequency questionnaire. J Ren Nutr. 2002 Jan;12(1):17-31. doi: 10.1053/jren.2002.29598. — View Citation

Malgorzewicz S, Woloszyk P, Chamienia A, Jankowska M, Debska-Slizien A. Obesity Risk Factors in Patients After Kidney Transplantation. Transplant Proc. 2018 Jul-Aug;50(6):1786-1789. doi: 10.1016/j.transproceed.2018.02.099. Epub 2018 Mar 13. — View Citation

Nettleton JA, Steffen LM, Palmas W, Burke GL, Jacobs DR Jr. Associations between microalbuminuria and animal foods, plant foods, and dietary patterns in the Multiethnic Study of Atherosclerosis. Am J Clin Nutr. 2008 Jun;87(6):1825-36. doi: 10.1093/ajcn/87.6.1825. — View Citation

Nicoletto BB, Fonseca NK, Manfro RC, Goncalves LF, Leitao CB, Souza GC. Effects of obesity on kidney transplantation outcomes: a systematic review and meta-analysis. Transplantation. 2014 Jul 27;98(2):167-76. doi: 10.1097/TP.0000000000000028. — View Citation

Raj DS, Sohn MB, Charytan DM, Himmelfarb J, Ikizler TA, Mehrotra R, Ramezani A, Regunathan-Shenk R, Hsu JY, Landis JR, Li H, Kimmel PL, Kliger AS, Dember LM; Hemodialysis Novel Therapies Consortium. The Microbiome and p-Inulin in Hemodialysis: A Feasibility Study. Kidney360. 2021 Jan 15;2(3):445-455. doi: 10.34067/KID.0006132020. eCollection 2021 Mar 25. — View Citation

Serrano M, Srivastava A, Buck G, Zhu B, Edupuganti L, Adegbulugbe E, Shankaranarayanan D, Kopp JB, Raj DS. Dietary Protein and Fiber Affect Gut Microbiome and Treg/Th17 Commitment in Chronic Kidney Disease Mice. Am J Nephrol. 2022;53(8-9):646-651. doi: 10.1159/000526957. Epub 2022 Nov 7. — View Citation

Shah B, Newman JD, Woolf K, Ganguzza L, Guo Y, Allen N, Zhong J, Fisher EA, Slater J. Anti-Inflammatory Effects of a Vegan Diet Versus the American Heart Association-Recommended Diet in Coronary Artery Disease Trial. J Am Heart Assoc. 2018 Dec 4;7(23):e011367. doi: 10.1161/JAHA.118.011367. — View Citation

Tan TG, Sefik E, Geva-Zatorsky N, Kua L, Naskar D, Teng F, Pasman L, Ortiz-Lopez A, Jupp R, Wu HJ, Kasper DL, Benoist C, Mathis D. Identifying species of symbiont bacteria from the human gut that, alone, can induce intestinal Th17 cells in mice. Proc Natl Acad Sci U S A. 2016 Dec 13;113(50):E8141-E8150. doi: 10.1073/pnas.1617460113. Epub 2016 Nov 23. — View Citation

Wallace TM, Levy JC, Matthews DR. Use and abuse of HOMA modeling. Diabetes Care. 2004 Jun;27(6):1487-95. doi: 10.2337/diacare.27.6.1487. — View Citation

Wing MR, Yang W, Teal V, Navaneethan S, Tao K, Ojo A, Guzman NN, Reilly M, Wolman M, Rosas SE, Cuevas M, Fischer M, Lustigova E, Master SR, Xie D, Appleby D, Joffe M, Kusek J, Feldman HI, Raj DS; Chronic Renal Insufficiency Cohort (CRIC) Study. Race modifies the association between adiposity and inflammation in patients with chronic kidney disease: findings from the chronic renal insufficiency cohort study. Obesity (Silver Spring). 2014 May;22(5):1359-66. doi: 10.1002/oby.20692. Epub 2014 Feb 11. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood electrolytes (Na, K, Cl, Ca, Phosphorous)	mEq/L	Baseline, week 10, 18, 26
Other	Urine protein	mg/L	Baseline, week 10, 18, 26
Other	Urine albumin	mg/L	Baseline, week 10, 18, 26
Other	Urine electrolytes (Na, K, Cl, Ca, Phosphorous)	mEq/L	Baseline, week 10, 18, 26
Primary	Th17/ Treg ratio	Th17/Treg cell ratio in peripheral blood. Results expressed as cell frequencies	Baseline, week 10, 18, 26
Primary	hsCRP	Plasma levels measured using enzyme-linked immunosorbent assay (ELISA) expressed as units/ mL	Baseline, week 10, 18, 26
Primary	Interleukin (IL) Levels (IL-6, IL-17, IL-21)	Plasma levels measured using ELISA expressed as units/ mL	Baseline, week 10, 18, 26
Primary	Weight	Kilograms	Baseline, week 10, 18, 26
Primary	BMI	Weight in kilograms (kg) and height (m) in meters will be combined to report BMI kg/m^2	Baseline, week 10, 18, 26
Primary	Anthropometry	Mid arm and abdominal circumference will be measured in centimeters	Baseline, week 18, 26
Primary	Blood pressure	Systolic blood pressure (mmHg)/ Diastolic blood pressure (mmHg)	Baseline, week 10, 18, 26
Primary	HbA1c	mmol/mol and percent (percent of total hemoglobin)	Baseline, week 10, 18, 26
Primary	Non-fasting blood glucose	mg/dL	Baseline, week 10, 18, 26
Primary	Total cholesterol	mg/dL	Baseline, week 10, 18, 26
Primary	Food frequency questionnaire	Nutrient intake and physical activity levels will be calculated	Baseline, week 18, 26
Primary	Weekly one day food recall	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	Estimated glomerular filtration rate	mL/min/1.73m^2	Baseline, week 10, 18, 26
Secondary	Creatinine	mg/dL	Baseline, week 10, 18, 26
Secondary	Kidney disease and quality of life (KDQOL-36)	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
Secondary	Changes in gut microbiome	Stool samples collected at pre-specified time points and analyzed by metagenomics for gut microbiome profile	Baseline, week 18, 26
Secondary	Low-density lipoprotein (LDL) cholesterol	mg/dL	Baseline, week 10, 18, 26
Secondary	High-density lipoprotein (HDL) cholesterol	mg/dL	Baseline, week 10, 18, 26
Secondary	Triglycerides	mg/dL	Baseline, week 10, 18, 26