Plant-based Diet for Kidney Transplant Recipients

Overseen By Ana Pabalan, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: George Washington University

Must be taking: Immunosuppressive

Disqualifiers: Allograft rejection, Heart failure, Liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

25 Participants Needed

Trial Summary

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. However, since participants must be on immunosuppressive medication, it seems you will continue with those.

What data supports the idea that Plant-based Diet for Kidney Transplant Recipients is an effective treatment?

The available research shows that plant-based diets are beneficial for managing chronic kidney disease and its complications. Although specific data on kidney transplant recipients is limited, plant-based diets have been effective in treating related conditions like diabetes, hypertension, and obesity, which are common in kidney disease patients. These diets may improve kidney health by reducing the need for medications and potentially slowing disease progression. Additionally, concerns about nutrient deficiencies in plant-based diets, such as protein inadequacy, may not be as significant as once thought, making the benefits of these diets more appealing. ^{1 2 3 4 5}

What safety data exists for plant-based diets in kidney transplant recipients?

The available research suggests that plant-based diets, including vegetarian and vegan diets, are generally safe and beneficial for patients with chronic kidney disease (CKD) and those on dialysis. These diets can improve kidney disease complications, reduce the need for nephroprotective medications, and potentially delay the progression of CKD. Concerns about hyperkalemia and protein inadequacy are not as significant as previously thought. However, specific evidence on plant-based diets for kidney transplant recipients is limited, and more research is needed to confirm their safety and efficacy in this group. ^{1 3 4 6 7}

Is a plant-based diet a promising treatment for kidney transplant recipients?

Yes, a plant-based diet is promising for kidney transplant recipients. It can help manage chronic kidney disease and improve kidney health by focusing on plant foods, which are linked to better health outcomes and may protect kidney function. ^{1 2 4 7 8}

What is the purpose of this trial?

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.

Research Team

Muralidharan Jagadeesan, MD

Principal Investigator

George Washington University

Eligibility Criteria

This trial is for kidney transplant recipients who are more than 3 months post-transplant, on stable immunosuppressive medication, speak English, have reliable internet access, and a kidney function (eGFR) over 45 ml/min/1.73 m^2 without active infections or inflammatory conditions.

Inclusion Criteria

My kidney function is good.

English speaking

Must have reliable internet access

Exclusion Criteria

History of acute or chronic allograft rejection

History of non-compliance

I have had cancer before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dietary Training

Participants receive instruction on transitioning to a plant-based diet through presentations, videos, informational documents, and group sessions.

2 weeks

Multiple group sessions (in-person)

Intervention

Participants follow a plant-based diet under supervision, with weekly phone calls and monthly in-person group sessions.

16 weeks

Weekly phone calls, monthly group sessions (in-person)

Unsupervised PBD

Participants continue the plant-based diet without dietary supervision, with ongoing assessments.

8 weeks

Weekly 1-day food recalls

Follow-up

Participants are monitored for safety and effectiveness after the intervention phase.

4 weeks

Treatment Details

Interventions

• Plant-based Diet

Trial Overview The study tests how a plant-based diet affects heart health markers and inflammation in people who've had a kidney transplant. Participants will switch to this diet for at least 16 weeks with support from the research team and provide blood, urine, fecal samples as well as complete health questionnaires.

Participant Groups

Group I: Plant-based diet Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

George Washington University

Lead Sponsor

Trials

263

Recruited

476,000+

Findings from Research

A low-protein, plant-based diet (0.6-0.8 g/kg/day) may help slow the decline of kidney function in transplant recipients, potentially due to reduced glomerular hyperfiltration.

High protein intake could negatively impact kidney allograft health, while diets like the Mediterranean and Dietary Approaches to Stop Hypertension show promising outcomes for kidney transplant longevity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional and dietary interventions to prolong renal allograft survival after kidney transplantation. Tantisattamo, E., Kalantar-Zadeh, K., Molnar, MZ.[2022]

Plant-based diets are associated with a reduced risk of chronic kidney disease (CKD) and may help slow its progression, as evidenced by observational studies linking reduced red and processed meat consumption to lower CKD risk.

Concerns about potassium overload and protein inadequacy from plant-based diets are largely unfounded, as these diets can be well-tolerated and provide sufficient protein when properly planned, making them a viable option for CKD prevention and management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plant-based diets for prevention and management of chronic kidney disease. Joshi, S., Hashmi, S., Shah, S., et al.[2021]

Plant-based diets may help prevent and treat chronic kidney disease by improving nutrient quality, reducing the need for medications, and potentially slowing disease progression, as supported by a review of existing evidence.

Concerns about risks like hyperkalemia and protein inadequacy associated with plant-based diets may be overstated, while the benefits for kidney health and patient quality of life are significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plant-Based Diets for Kidney Disease: A Guide for Clinicians. Joshi, S., McMacken, M., Kalantar-Zadeh, K.[2021]

Plant-based diets, which focus on unprocessed fruits, vegetables, nuts, whole grains, oils, and beans, have shown promise in preventing and treating lifestyle diseases such as type 2 diabetes, hypertension, and obesity.

Preliminary findings suggest that plant-based diets may also be beneficial for patients with kidney failure, including those undergoing dialysis, although more research is needed to confirm these effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mini Review of Plant-Based Diets in Hemodialysis. Dupuis, L., Brown-Tortorici, A., Kalantar-Zadeh, K., et al.[2022]

Plant-based diets may help delay the progression of diabetic kidney disease (DKD) by focusing on whole foods and reducing processed foods and advanced glycation end products (AGE).

Current evidence is limited and mostly from smaller studies, highlighting the need for larger trials to better understand the impact of plant-based diets on kidney function and overall health outcomes in DKD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet and Diabetic Kidney Disease: Plant Versus Animal Protein. Moorthi, RN., Vorland, CJ., Hill Gallant, KM.[2022]

A whole food, plant-based diet can provide significant health benefits for patients with chronic kidney disease (CKD), including reduced dietary acid load, improved nutrient intake, and potential cardiovascular benefits.

While this diet can be beneficial, it may also present challenges such as the need for specific cooking skills and higher costs, which could limit its acceptability and accessibility for some patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In the "Plant-Based" Era, Patients With Chronic Kidney Disease Should Focus on Eating Healthy. Freeman, NS., Turner, JM.[2023]

Plant-based diets (PBDs) are associated with protective effects against the development and progression of chronic kidney disease (CKD), offering advantages over conventional low-protein diets that include animal proteins.

In patients with advanced CKD, very-low-protein plant-based diets supplemented with heteroanalogues may delay the need for dialysis and help manage metabolic disturbances more effectively than standard low-protein diets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Plant-Based Diets in Preventing and Mitigating Chronic Kidney Disease: More Light than Shadows. Zarantonello, D., Brunori, G.[2023]

At very low protein levels (0.5 g/kg/d), all three types of low protein diets (lacto-ovo vegetarian, omnivorous, and vegan) failed to meet the Recommended Dietary Allowances for several essential amino acids, indicating potential nutritional inadequacy for patients with chronic kidney disease.

The omnivorous low protein diet was more nutritionally adequate than the vegan and lacto-ovo diets, meeting essential amino acid requirements at 0.6 g/kg/d, while the other two diets required careful planning to avoid deficiencies, particularly in lysine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional Adequacy of Essential Nutrients in Low Protein Animal-Based and Plant-Based Diets in the United States for Chronic Kidney Disease Patients. Tallman, DA., Khor, BH., Karupaiah, T., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Nutritional and dietary interventions to prolong renal allograft survival after kidney transplantation. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Plant-based diets for prevention and management of chronic kidney disease. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Plant-Based Diets for Kidney Disease: A Guide for Clinicians. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

A Mini Review of Plant-Based Diets in Hemodialysis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Diet and Diabetic Kidney Disease: Plant Versus Animal Protein. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

In the "Plant-Based" Era, Patients With Chronic Kidney Disease Should Focus on Eating Healthy. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

The Role of Plant-Based Diets in Preventing and Mitigating Chronic Kidney Disease: More Light than Shadows. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Nutritional Adequacy of Essential Nutrients in Low Protein Animal-Based and Plant-Based Diets in the United States for Chronic Kidney Disease Patients. [2023]