Plant-based Diet for Kidney Transplant Recipients

NCT06186843 | Active Not Recruiting

• 1 other identifier: KTX-PBD-001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Kidney transplant; Lifestyle change; Plant-based diet; Metabolic syndrome; Diabetes; Hypertension; Kidney function; Inflammatory states

Outcome Measures

Primary Outcomes (12)

• Th17/ Treg ratio

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

  Baseline, week 10, 18, 26

• hsCRP

  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)

  Plasma levels measured using ELISA expressed as units/ mL

  Baseline, week 10, 18, 26

• Weight

  Kilograms

  Baseline, week 10, 18, 26

• BMI

  Weight in kilograms (kg) and height (m) in meters will be combined to report BMI kg/m\^2

  Baseline, week 10, 18, 26

• Anthropometry

  Mid arm and abdominal circumference will be measured in centimeters

  Baseline, week 18, 26

• Blood pressure

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

  Baseline, week 10, 18, 26

• HbA1c

  mmol/mol and percent (percent of total hemoglobin)

  Baseline, week 10, 18, 26

• Non-fasting blood glucose

  mg/dL

  Baseline, week 10, 18, 26

• Total cholesterol

  mg/dL

  Baseline, week 10, 18, 26

• Food frequency questionnaire

  Nutrient intake and physical activity levels will be calculated

  Baseline, week 18, 26

• 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 Outcomes (7)

• Estimated glomerular filtration rate

  Baseline, week 10, 18, 26

• Creatinine

  Baseline, week 10, 18, 26

• Kidney disease and quality of life (KDQOL-36)

  Baseline, week 18, 26

• Changes in gut microbiome

  Baseline, week 18, 26

• Low-density lipoprotein (LDL) cholesterol

  Baseline, week 10, 18, 26

Other Outcomes (4)

• Blood electrolytes (Na, K, Cl, Ca, Phosphorous)

  Baseline, week 10, 18, 26

• Urine protein

  Baseline, week 10, 18, 26

• Urine albumin

  Baseline, week 10, 18, 26

Study Arms (1)

Plant-based diet

EXPERIMENTAL

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

Behavioral: Plant-based diet

Interventions

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.

Plant-based diet

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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

You may not qualify if:

• Acute/ chronic allograft rejection
• History of non-compliance
• Advance heart failure
• Liver disease
• Pregnancy
• Malignancy
• Chronic Infection
• Currently following a plant-based diet

Sponsors & Collaborators

• George Washington University: lead

Study Sites (1)

Transplant Institute

Washington D.C., District of Columbia, 20037, United States

Location

Related Publications (18)

• 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.

  PMID: 18021984 BACKGROUND

• 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.

  PMID: 29937291 BACKGROUND

• 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.

  PMID: 30571591 BACKGROUND

• 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.

  PMID: 27911839 BACKGROUND

• 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.

  PMID: 35369018 BACKGROUND

• 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.

  PMID: 36349783 BACKGROUND

• 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.

  PMID: 21326138 BACKGROUND

• 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.

  PMID: 26044837 BACKGROUND

• 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.

  PMID: 24911038 BACKGROUND

• 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.

  PMID: 24415732 BACKGROUND

• 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.

  PMID: 19541816 BACKGROUND

• 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.

  PMID: 18541574 BACKGROUND

• 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.

  PMID: 24679894 BACKGROUND

• Cyrino LG, 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.

  PMID: 34307973 BACKGROUND

• 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.

  PMID: 32775832 BACKGROUND

• 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.

  PMID: 32750456 BACKGROUND

• 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.

  PMID: 11823990 BACKGROUND

• 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.

  PMID: 15161807 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hypertension; Diabetes Mellitus; Metabolic Syndrome; Inflammation; Feeding Behavior

Interventions

Diet, Plant-Based

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism; Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Muralidharan Jagadeesan, MD

  George Washington University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: There will be no masking.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A single group of kidney transplant recipients will transition to a plant-based diet and be followed for 24 weeks.

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: January 2, 2024
• Study Start: February 29, 2024
• Primary Completion: March 25, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)