Dietary Intervention for Kidney Transplant Health

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Disqualifiers: Rejection episode, Alternative nutrition, Plant-based diet, others

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

Compensation: Varies

Number of Visits: 4

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if teaching kidney transplant recipients to follow a whole-food, plant-based diet improves their health compared to standard care. Participants will either learn about this diet or continue their usual care routine. The trial seeks individuals who received a kidney transplant 2 to 12 months ago, have good kidney function, and face issues like high blood pressure, high blood sugar, or being overweight. As an unphased trial, it offers a unique opportunity to explore new dietary approaches to enhance post-transplant health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on dietary changes rather than medication adjustments.

What prior data suggests that this dietary intervention is safe for kidney transplant recipients?

Research has shown that plant-based diets can be safe and beneficial for kidney health. For example, the Adventist Health study found that eating a plant-based diet lowered the risk of dying from any cause, suggesting these diets might be safe for people with kidney problems. Ongoing research is examining the safety of these diets for individuals with chronic kidney disease (CKD), focusing on issues like high potassium or low protein levels in the blood.

Overall, these findings suggest that a whole-food plant-based diet is generally well-tolerated and could be a safe choice for kidney transplant patients seeking to improve their health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the whole-food, plant-based dietary pattern for kidney transplant health because it offers a unique, holistic approach compared to traditional post-transplant care, which typically relies on medication to manage organ rejection and other complications. This diet is packed with nutrients and antioxidants that may reduce inflammation and boost overall kidney function without the side effects commonly associated with immunosuppressive drugs. Additionally, it emphasizes natural, unprocessed foods, which could lead to better long-term health outcomes by supporting heart health and reducing the risk of diabetes, both of which are crucial for kidney transplant patients.

What evidence suggests that a Whole-Food Plant-Based Dietary Pattern could be effective for kidney transplant health?

Research has shown that people who consume a lot of plant-based foods tend to have a lower risk of developing chronic kidney disease (CKD). One study found that 14,686 adults who followed a healthy plant-based diet reduced their risk of CKD by 14% over 24 years and experienced a slower decline in kidney function. Plant-based diets can also slow CKD progression and help manage related health issues. This type of diet might lower high levels of potassium and phosphorus, which are important for kidney health. In this trial, participants in the intervention arm will follow a whole-food plant-based diet to assess its potential benefits for kidney health in transplant recipients. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for kidney transplant recipients aged 18 or older, with a history of high blood sugar or diabetes, overweight status (BMI >= 25), and within 2-12 months post-transplant. They should have an eGFR >= 20 mL/min and may also have high blood pressure. It's not for those already on plant-based diets, unable to consent, prisoners, with recent organ rejection, GI feeding tubes, language barriers regarding English, visual impairment or unwillingness to change diet.

Inclusion Criteria

I am over 18 and have received a kidney transplant.

My kidney function is at a safe level for the trial.

I have a history of high blood sugar or am on diabetes medication.

Exclusion Criteria

You have had a rejection episode before joining the study.

Pregnant or breastfeeding

You already follow a diet that consists only of plant-based foods.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dietary Counseling

Participants receive dietary counseling focusing on a whole-food plant-based diet, with group-based sessions weekly for the first month, then biweekly for 5 months

6 months

4 weekly visits, then 10 biweekly visits

Follow-up

Participants are monitored for safety and effectiveness after dietary intervention

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Whole-Food Plant-Based Dietary Pattern

Trial Overview The study tests a dietary education program that teaches patients how to follow a whole-food plant-based diet versus the standard care given after kidney transplantation. Participants are randomly assigned to one of these two groups shortly after their transplant surgery.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Group II: Control Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Academy of Nutrition and Dietetics

Collaborator

Trials

25

Recruited

5,600+

Published Research Related to This Trial

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]

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]

A whole food plant-based (WFPB) diet may help slow the progression of chronic kidney disease (CKD) and reduce the risk of related conditions like cardiovascular disease and diabetes, based on emerging evidence.

While adopting a WFPB diet could be beneficial for CKD patients, careful attention to nutrient content is necessary to prevent malnutrition, highlighting the need for further research on its safety and effectiveness in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ameliorating Chronic Kidney Disease Using a Whole Food Plant-Based Diet. Adair, KE., Bowden, RG.[2021]

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 healthy eating pattern, particularly the Mediterranean and DASH diets, is recommended for kidney transplant recipients as they lower the risk of metabolic and cardiovascular diseases by emphasizing fresh and plant-based foods while reducing meat and processed food intake.

Current dietary recommendations for kidney transplant patients should focus on overall eating patterns rather than single nutrients, as this approach is more practical and effective for long-term health maintenance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Narrative Review of Dietary Approaches for Kidney Transplant Patients. Cyrino, LG., Galpern, J., Moore, L., et al.[2023]

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]

A community-based dietary program using a whole food plant-based (WFPB) diet resulted in a significant reduction in BMI after 6 months, with an average decrease of 4.4 kg/m² compared to only 0.4 kg/m² in the control group.

Participants following the WFPB diet also experienced a meaningful reduction in cholesterol levels, achieving a significant decrease at 12 months, with no serious harms reported, indicating the diet's safety and potential efficacy for improving health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The BROAD study: A randomised controlled trial using a whole food plant-based diet in the community for obesity, ischaemic heart disease or diabetes. Wright, N., Wilson, L., Smith, M., et al.[2018]

In a pilot program involving 17 participants, the adoption of a Whole Food Plant-based (WFPB) diet resulted in significant weight loss (4.3 kg) and improvements in cholesterol levels, including a decrease in total cholesterol and triglycerides, and an increase in HDL (good cholesterol).

The program, which included educational sessions led by a gastroenterologist, demonstrated the potential effectiveness of WFPB diets in a clinical setting, particularly for patients with conditions like hyperlipidemia and hypertension, suggesting a need for larger-scale studies to further validate these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a Whole Food Plant Based Diet in a Food as Prevention Program in a Resource Constrained Environment. Ganguli, SC., Russell, LA., Tsoi, KS.[2023]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8258457/

A Narrative Review of Dietary Approaches for Kidney ... In 14,686 adults followed for 24 years, higher adherence to a healthy plant-based diet was associated with a 14% reduction in the risk of CKD, and slower eGFR ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04171778

Effects of Whole Food, Plant-Based Nutrition on Chronic ... Safety of a WFPB diet in subjects with CKD will be tested with respect to the development of elevated serum potassium and phosphorus, hypoalbuminemia (low blood ...

3. ajkd.org ajkd.org/article/S0272-6386(23)00936-8/fulltext

Adherence to Plant-Based Diets and Risk of CKD ... Studies have shown that generally healthy individuals who consume diets rich in plant foods have a lower risk of incident chronic kidney ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10573653/

The Role of Plant-Based Diets in Preventing and Mitigating ... In patients with chronic kidney disease, several observational studies have shown that high adherence to different healthy dietary patterns rich in plant foods ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1051227622001650

Patient Perception of Plant Based Diets for Kidney Disease Plant-based diets can delay the progression of chronic kidney disease (CKD) and help manage complications and comorbid conditions.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12004285/

Dietary Guidelines Post Kidney Transplant This narrative review aims to summarise current knowledge of specific macro and micronutrients and their effect on allograft recovery and ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06871722?term=AREA%5BBasicSearch%5D(AREA%5BBasicSearch%5D(AREA%5BBasicSearch%5D(PLANET%201)))&rank=7

How a Plant-Based Diet Affects Blood Pressure and Gut ... Evidence has demonstrated the association of gut microbiota on kidney transplant outcomes such as hypertension, allograft rejection, immunosuppressant ...