Plant-based Diet for Kidney Transplant Recipients

Not currently recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effects of a plant-based diet on kidney transplant recipients, focusing on heart health and inflammation. Participants will adopt a plant-based diet for at least 16 weeks, while researchers monitor health markers such as heart and blood health. The trial is ideal for individuals who received a kidney transplant over three months ago, do not have active infections, and are not currently following a plant-based diet. Participants must be willing to provide blood and other samples, complete surveys, and meet with the study team. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research on diet and transplant health.

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 prior data suggests that a plant-based diet is safe for kidney transplant recipients?

Research has shown that plant-based diets are generally safe and can benefit kidney health. In a large study of over 14,000 adults, those who followed a healthy plant-based diet had a 14% lower risk of developing chronic kidney disease. This finding suggests that a plant-based diet might be easy to follow and beneficial for kidney function.

Other studies have found that people with kidney problems who consume more plant foods often experience positive results. For example, plant-based diets have been linked to better blood pressure and improved outcomes for kidney transplant patients. Additionally, following a plant-based diet is associated with a lower risk of death from any cause for those with chronic kidney disease.

Overall, current evidence suggests that plant-based diets are safe and could improve health for kidney transplant patients. Participants in clinical trials can usually expect these diets to be well-tolerated, but discussing personal health conditions with healthcare providers remains important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for kidney transplant recipients, which typically includes immunosuppressive drugs to prevent organ rejection, a plant-based diet offers a unique approach by focusing on nutrition. Researchers are excited about this treatment because it emphasizes whole foods that are rich in antioxidants and anti-inflammatory compounds, potentially improving overall health and reducing the risk of chronic diseases. Additionally, a plant-based diet may support kidney function and reduce the burden on the transplanted organ, offering a complementary strategy alongside traditional medications.

What evidence suggests that a plant-based diet might be an effective treatment for kidney transplant recipients?

Research has shown that a plant-based diet benefits kidney health. One study found that adults following a healthy plant-based diet had a 14% lower risk of developing chronic kidney disease (CKD) over 24 years. Another study discovered that plant-based diets reduced the risk of death for individuals with kidney issues. Additionally, these diets were linked to a 12% lower risk of kidney function decline, as measured by the eGFR test, which assesses kidney performance. In this trial, participants will follow a plant-based diet to evaluate its potential to improve kidney health and reduce inflammation in individuals who have undergone a kidney transplant. ^{1 5 6 7 8}

Who Is on the Research Team?

Muralidharan Jagadeesan, MD

Principal Investigator

George Washington University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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, 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 (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]

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]

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]

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]

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 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]

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