Kidney Disease, ChronicNCT06186843
Plant-based Diet for Kidney Transplant Recipients
A study testing Plant-based diet in people with Kidney Disease, Chronic and Transplant Complication, run by George Washington University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Kidney Disease, Chronic, Transplant Complication, Hypertension
- What is being tested?
- Plant-based diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Feb 2024to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 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
Who cannot join
- Acute/ chronic allograft rejection
- History of non-compliance
- Advance heart failure
- Liver disease
- Pregnancy
- Malignancy
- Chronic Infection
- Currently following a plant-based diet
Trial locations and contacts
1 site in 1 country.
United States1 site
Transplant Institute
Washington D.C., District of Columbia, 20037
About this study
Official title: Effect of Plant-based Diet on Cardiometabolic and Inflammatory Parameters in Kidney Transplant Recipients
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
Read more
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.
Read the 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.
- Conditions
- Kidney Disease, Chronic, Transplant Complication, Hypertension, Diabetes Mellitus, Metabolic Syndrome, Inflammation
- Being tested
- Plant-based diet
- Keywords
- Kidney transplant, Lifestyle change, Plant-based diet, Metabolic syndrome, Diabetes, Hypertension, Kidney function, Inflammatory states
- Medical subject headings
- Renal Insufficiency, Chronic, Hypertension, Diabetes Mellitus, Metabolic Syndrome, Inflammation, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant-based dietBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Plant-based diet | Experimental | The group will follow a plant-based diet. Compliance will be checked with dietary questionnaires. Receives: Behavioral: Plant-based diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Th17/ Treg ratio
Th17/Treg cell ratio in peripheral blood. Results expressed as cell frequencies
Measured: Baseline, week 10, 18, 26
hsCRP
Plasma levels measured using enzyme-linked immunosorbent assay (ELISA) expressed as units/ mL
Measured: Baseline, week 10, 18, 26
Interleukin (IL) Levels (IL-6, IL-17, IL-21)
Plasma levels measured using ELISA expressed as units/ mL
Measured: Baseline, week 10, 18, 26
Weight
Kilograms
Measured: Baseline, week 10, 18, 26
BMI
Weight in kilograms (kg) and height (m) in meters will be combined to report BMI kg/m^2
Measured: Baseline, week 10, 18, 26
Anthropometry
Mid arm and abdominal circumference will be measured in centimeters
Measured: Baseline, week 18, 26
Blood pressure
Systolic blood pressure (mmHg)/ Diastolic blood pressure (mmHg)
Measured: Baseline, week 10, 18, 26
HbA1c
mmol/mol and percent (percent of total hemoglobin)
Measured: Baseline, week 10, 18, 26
Non-fasting blood glucose
mg/dL
Measured: Baseline, week 10, 18, 26
Total cholesterol
mg/dL
Measured: Baseline, week 10, 18, 26
Food frequency questionnaire
Nutrient intake and physical activity levels will be calculated
Measured: 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
Measured: Once per week at baseline and weeks 3-18
Secondary outcomes (7)
Estimated glomerular filtration rate
mL/min/1.73m^2
Measured: Baseline, week 10, 18, 26
Creatinine
mg/dL
Measured: Baseline, week 10, 18, 26
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
Measured: Baseline, week 18, 26
Changes in gut microbiome
Stool samples collected at pre-specified time points and analyzed by metagenomics for gut microbiome profile
Measured: Baseline, week 18, 26
Low-density lipoprotein (LDL) cholesterol
mg/dL
Measured: Baseline, week 10, 18, 26
High-density lipoprotein (HDL) cholesterol
mg/dL
Measured: Baseline, week 10, 18, 26
Triglycerides
mg/dL
Measured: Baseline, week 10, 18, 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start29 Feb 2024
- Primary completion25 Mar 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Kidney Disease, ChronicStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single group of kidney transplant recipients will transition to a plant-based diet and be followed for 24 weeks.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muralidharan Jagadeesan, George Washington University
- Investigators
- Muralidharan Jagadeesan, MD, Principal investigator, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06186843
- Sponsor's protocol ID
- KTX-PBD-001
- Status last verified
- May 2026
- First submitted
- 18 Oct 2023
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The details of the plan are still being decided.
Publications
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.
PubMed 18021984Malgorzewicz 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.
PubMed 29937291Shah 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.
PubMed 30571591Tan 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.
PubMed 27911839Raj 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.
PubMed 35369018Serrano 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.
PubMed 36349783Hoogeveen 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.
PubMed 21326138Hill 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.
PubMed 26044837Nicoletto 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.
PubMed 24911038Wing 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.
PubMed 24415732Abedini 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.
PubMed 19541816Nettleton 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.
PubMed 18541574Gutierrez 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.
PubMed 24679894Cyrino 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.
PubMed 34307973Gao 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.
PubMed 32775832
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Plant-based Diet on Cardiometabolic and Inflammatory Parameters in Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT06186843
- Acronym / sponsor ID
- KTX-PBD-001
- Conditions
- Kidney Disease, Chronic, Transplant Complication, Hypertension, Diabetes Mellitus, Metabolic Syndrome, Inflammation
- Keywords
- Kidney transplant, Lifestyle change, Plant-based diet, Metabolic syndrome, Diabetes, Hypertension, Kidney function, Inflammatory states
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- 25 Mar 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 2 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single group of kidney transplant recipients will transition to a plant-based diet and be followed for 24 weeks.
| Arm | Type | Receives |
|---|---|---|
| Plant-based diet | Experimental | Behavioral: Plant-based dietThe group will follow a plant-based diet. Compliance will be checked with dietary questionnaires. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- > 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
Key exclusion criteria (8 listed)
- Acute/ chronic allograft rejection
- History of non-compliance
- Advance heart failure
- Liver disease
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plant-based dietA 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. | Behavioural | Plant-based diet |
Primary outcome
Th17/ Treg ratio
Time frame: Baseline, week 10, 18, 26
Th17/Treg cell ratio in peripheral blood. Results expressed as cell frequencies
hsCRP
Time frame: Baseline, week 10, 18, 26
Plasma levels measured using enzyme-linked immunosorbent assay (ELISA) expressed as units/ mL
Interleukin (IL) Levels (IL-6, IL-17, IL-21)
Time frame: Baseline, week 10, 18, 26
Plasma levels measured using ELISA expressed as units/ mL
Weight
Time frame: Baseline, week 10, 18, 26
Kilograms
BMI
Time frame: Baseline, week 10, 18, 26
Weight in kilograms (kg) and height (m) in meters will be combined to report BMI kg/m^2
Anthropometry
Time frame: Baseline, week 18, 26
Mid arm and abdominal circumference will be measured in centimeters
Blood pressure
Time frame: Baseline, week 10, 18, 26
Systolic blood pressure (mmHg)/ Diastolic blood pressure (mmHg)
HbA1c
Time frame: Baseline, week 10, 18, 26
mmol/mol and percent (percent of total hemoglobin)
Non-fasting blood glucose
Time frame: Baseline, week 10, 18, 26
mg/dL
Total cholesterol
Time frame: Baseline, week 10, 18, 26
mg/dL
Food frequency questionnaire
Time frame: Baseline, week 18, 26
Nutrient intake and physical activity levels will be calculated
Weekly one day food recall
Time frame: 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
7 secondary outcomes
Estimated glomerular filtration rate
Time frame: Baseline, week 10, 18, 26
Creatinine
Time frame: Baseline, week 10, 18, 26
Kidney disease and quality of life (KDQOL-36)
Time frame: Baseline, week 18, 26
Changes in gut microbiome
Time frame: Baseline, week 18, 26
Low-density lipoprotein (LDL) cholesterol
Time frame: Baseline, week 10, 18, 26
High-density lipoprotein (HDL) cholesterol
Time frame: Baseline, week 10, 18, 26
Triglycerides
Time frame: Baseline, week 10, 18, 26
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Background: PubMed 18021984Jezior 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.
- Background: PubMed 29937291Malgorzewicz 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.
- Background: PubMed 30571591Shah 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.
- Background: PubMed 27911839Tan 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.
- Background: PubMed 35369018Raj 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.
- Background: PubMed 36349783Serrano 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.
- Background: PubMed 21326138Hoogeveen 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.
- Background: PubMed 26044837Hill 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.
- Background: PubMed 24911038Nicoletto 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.
- Background: PubMed 24415732Wing 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.
- Background: PubMed 19541816Abedini 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.
- Background: PubMed 18541574Nettleton 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.
- Individual participant dataSharing planned: Yes. The details of the plan are still being decided.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muralidharan Jagadeesan, MD principal investigator
George Washington University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plant-based diet in people with Kidney Disease, Chronic and Transplant Complication, run by George Washington University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Th17/ Treg ratio (time frame: Baseline, week 10, 18, 26). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06186843, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.