120 Participants Needed

Dietary Intervention for Kidney Transplant Health

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, Davis
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Randomized controlled trial of a curriculum intervention teaching patients to eat a whole-food plant-based dietary pattern versus standard of care in kidney transplant recipients within the first few months of transplant

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.

Is a whole-food plant-based diet safe for humans?

A whole-food plant-based diet is generally considered safe for humans and has shown benefits for conditions like chronic kidney disease, diabetes, and heart disease. However, it's important to ensure a balanced intake of nutrients to avoid malnutrition, especially in people with specific health conditions.12345

How does the Whole-Food Plant-Based Diet treatment differ from other treatments for kidney transplant health?

The Whole-Food Plant-Based Diet is unique because it focuses on consuming mostly plant foods, which can be alkaline-producing and anti-inflammatory, potentially offering protective benefits for kidney function. Unlike other treatments that may focus on single nutrients, this diet emphasizes an overall eating pattern that may help slow kidney disease progression and improve transplant outcomes.35678

What data supports the effectiveness of the treatment Whole-Food Plant-Based Dietary Pattern for kidney transplant health?

Research suggests that plant-based diets can help protect kidney function and slow the progression of chronic kidney disease by reducing inflammation and promoting a healthier environment in the body. These diets have been associated with benefits like lowering the risk of heart disease and diabetes, which are important for kidney health.35679

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.
See 4 more

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.
See 7 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Group II: ControlActive Control1 Intervention

Find a Clinic Near You

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

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.
A Narrative Review of Dietary Approaches for Kidney Transplant Patients.Cyrino, LG., Galpern, J., Moore, L., et al.[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.
Diet and Diabetic Kidney Disease: Plant Versus Animal Protein.Moorthi, RN., Vorland, CJ., Hill Gallant, KM.[2022]
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.
Nutritional and dietary interventions to prolong renal allograft survival after kidney transplantation.Tantisattamo, E., Kalantar-Zadeh, K., Molnar, MZ.[2022]

Citations

A Narrative Review of Dietary Approaches for Kidney Transplant Patients. [2023]
Diet and Diabetic Kidney Disease: Plant Versus Animal Protein. [2022]
Nutritional and dietary interventions to prolong renal allograft survival after kidney transplantation. [2022]
The Role of Plant-Based Diets in Preventing and Mitigating Chronic Kidney Disease: More Light than Shadows. [2023]
Ameliorating Chronic Kidney Disease Using a Whole Food Plant-Based Diet. [2021]
The BROAD study: A randomised controlled trial using a whole food plant-based diet in the community for obesity, ischaemic heart disease or diabetes. [2018]
Implementation of a Whole Food Plant Based Diet in a Food as Prevention Program in a Resource Constrained Environment. [2023]
In the "Plant-Based" Era, Patients With Chronic Kidney Disease Should Focus on Eating Healthy. [2023]
Plant-based diets for prevention and management of chronic kidney disease. [2021]
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