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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:
Participants will be asked to:
Researchers will compare baseline measurements with future measurements for each participant.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plant-based diet | Experimental | The group will follow a plant-based diet. Compliance will be checked with dietary questionnaires. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Estimated glomerular filtration rate | mL/min/1.73m^2 | Baseline, week 10, 18, 26 |
| Creatinine | mg/dL | Baseline, week 10, 18, 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Blood electrolytes (Na, K, Cl, Ca, Phosphorous) | mEq/L | Baseline, week 10, 18, 26 |
| Urine protein | mg/L | Baseline, week 10, 18, 26 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Muralidharan Jagadeesan, MD | George Washington University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Transplant Institute | Washington D.C. | District of Columbia | 20037 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18021984 | Background | 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. | |
| 29937291 | 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. |
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The details of the plan are still being decided.
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D006973 | Hypertension |
| D003920 | Diabetes Mellitus |
| D024821 | Metabolic Syndrome |
| D007249 | Inflammation |
| D005247 | Feeding Behavior |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D000095500 | Diet, Plant-Based |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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A single group of kidney transplant recipients will transition to a plant-based diet and be followed for 24 weeks.
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There will be no masking.
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|
| 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 |
| 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 |
| Changes in gut microbiome | Stool samples collected at pre-specified time points and analyzed by metagenomics for gut microbiome profile | Baseline, week 18, 26 |
| Low-density lipoprotein (LDL) cholesterol | mg/dL | Baseline, week 10, 18, 26 |
| High-density lipoprotein (HDL) cholesterol | mg/dL | Baseline, week 10, 18, 26 |
| Triglycerides | mg/dL | Baseline, week 10, 18, 26 |
| Urine albumin | mg/L | Baseline, week 10, 18, 26 |
| Urine electrolytes (Na, K, Cl, Ca, Phosphorous) | mEq/L | Baseline, week 10, 18, 26 |
| 30571591 | 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. |
| 27911839 | 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. |
| 35369018 | 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. |
| 36349783 | 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. |
| 21326138 | 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. |
| 26044837 | 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. |
| 24911038 | 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. |
| 24415732 | 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. |
| 19541816 | 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. |
| 18541574 | 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. |
| 24679894 | 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. |
| 34307973 | 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. |
| 32775832 | 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. |
| 32750456 | 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. |
| 11823990 | 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. |
| 15161807 | 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. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D001522 | Behavior, Animal |
| D001519 | Behavior |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |