Trial Summary
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.
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.
12345What 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.
13467Is 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.
12478Eligibility 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
+3 more
Exclusion Criteria
History of acute or chronic allograft rejection
History of non-compliance
I have had cancer before.
+5 more
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Plant-based dietExperimental Treatment1 Intervention
The group will follow a plant-based diet. Compliance will be checked with dietary questionnaires.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Transplant InstituteWashington, United States
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Who Is Running the Clinical Trial?
George Washington UniversityLead Sponsor
References
Nutritional and dietary interventions to prolong renal allograft survival after kidney transplantation. [2022]Diet plays an important role in slowing progression of chronic kidney disease in native and transplanted kidneys. There is limited evidence on the association on dietary intake with renal allograft function. Mechanisms of major nutrients and dietary patterns with focusing on a plant-based diet related to kidney transplant health and longevity are reviewed.
Plant-based diets for prevention and management of chronic kidney disease. [2021]Plant-based diets have been used with growing popularity for the treatment of a wide range of lifestyle-related diseases, including diabetes, hypertension, and obesity. With the reinvigoration of the dietary management of chronic kidney disease (CKD) and the use of low protein diets for secondary prevention of CKD to delay or prevent dialysis therapy, there is an increasing interest in the potential role of plant-based diets for these patients.
Plant-Based Diets for Kidney Disease: A Guide for Clinicians. [2021]In recent years, a growing body of evidence has emerged on the benefits of plant-based diets for the prevention and treatment of lifestyle diseases. In parallel, data now exist regarding the treatment of chronic kidney disease and its most common complications with this dietary pattern. Improving the nutrient quality of foods consumed by patients by including a higher proportion of plant-based foods while reducing total and animal protein intake may reduce the need for or complement nephroprotective medications, improve kidney disease complications, and perhaps favorably affect disease progression and patient survival. In this In Practice article, we review the available evidence on plant-dominant fiber-rich diet as it relates to kidney disease prevention, chronic kidney disease incidence and progression, metabolic acidosis, hyperphosphatemia, hypertension, uremic toxins, need for kidney replacement therapy including dialysis, patient satisfaction and quality of life, and mortality. Further, concerns of hyperkalemia and protein inadequacy, which are often associated with plant-based diets, are also reviewed in the context of available evidence. It is likely that the risks for both issues may not have been as significant as previously thought, while the advantages are vast. In conclusion, the risk to benefit ratio of plant-based diets appears to be tilting in favor of their more prevalent use.
A Mini Review of Plant-Based Diets in Hemodialysis. [2022]Plant-based diets are defined as an eating pattern focused on the consumption of unprocessed fruits, vegetables, nuts, whole grains, oils, and beans. They can include various forms of vegetarian, vegan, DASH, and Mediterranean diets. Plant-based diets have proven useful in the prevention and treatment of several lifestyle diseases like type 2 diabetes, hypertension, and obesity. Recently, a growing body of literature has emerged regarding plant-based diets for patients with kidney failure, including those on dialysis. Although evidence is still limited, preliminary findings are encouraging.
Diet and Diabetic Kidney Disease: Plant Versus Animal Protein. [2022]The goal of this review is to present an overview of the evidence on the effectiveness of plant-based diets in delaying progression of diabetic kidney disease (DKD).
In the "Plant-Based" Era, Patients With Chronic Kidney Disease Should Focus on Eating Healthy. [2023]In the era of plant-based diets, it is important for Nephrology providers to know the evidence regarding their healthfulness in patients with chronic kidney disease (CKD). A whole food, plant-based diet, which emphasizes fresh, minimally processed or refined plant-based foods and limits animal products, has shown benefits for patients with CKD. These include reduced dietary acid load, lower bioavailability of potassium and phosphorus, increased dietary fiber intake, nutritional adequacy, and cardiovascular and mortality benefits. Potential drawbacks include the need for specific knowledge, skills, and cost involved in preparing varied, healthy, and appetizing plant-based meals, leading to lower acceptability and accessibility to certain populations. Liberalization of the standard CKD diet to include healthy, minimally processed foods such as fruits, vegetables, nuts, legumes, and whole grains is likely beneficial, though more research is needed to determine whether a plant-based-only diet is the optimal way to achieve healthier eating in patients with CKD.
The Role of Plant-Based Diets in Preventing and Mitigating Chronic Kidney Disease: More Light than Shadows. [2023]Chronic kidney disease (CKD) is a non-communicable disease that affects >10% of the general population worldwide; the number of patients affected by CKD is increasing due in part to the rise in risk factors such as obesity, hypertension, and diabetes mellitus. As many studies show, diet can be an important tool for preventing and mitigating the onset of non-communicable diseases. Plant-based diets (PBDs) are those that emphasize the consumption of plant foods and may or may not include small or moderate amounts of animal foods. Recently, these diets have received increasing interest because they have been associated with favourable effects on health and also appear to protect against the development and progression of CKD. PBDs, which are associated with protein restrictions, seem to offer adjunctive advantages in patients with chronic kidney disease, as compared to conventional low-protein diets that include animal proteins. The principal aims of this review are to provide a comprehensive overview of the existing literature regarding the role of plant-based diets and low-protein, plant-based diets in the context of chronic kidney disease. Moreover, we try to clarify the definition of plant-based diets, and then we analyse possible concerns about the use of PBDs in patients with chronic kidney disease (nutritional deficiency and hyperkalaemia risk). Finally, we offer some strategies to increase the nutritional value of plant-based low-protein diets. In the Materials and Methods section, many studies about plant-based diets and low-protein plant-based diets (e.g., the very-low-protein diet and vegan low-protein diet, LPD) in chronic kidney disease were considered. In the Results and Conclusion section, current data, most from observational studies, agree upon the protective effect of plant-based diets on kidney function. Moreover, in patients with advanced CKD, low-protein plant-based options, especially a very-low-protein diet supplemented with heteroanalogues (VLPDs), compared to a conventional LPD appear to offer adjunctive advances in terms of delaying dialysis and mitigating metabolic disturbances. However, further studies are necessary to better investigate the possible metabolic and cardiovascular advantages of plant-based LPDs versus conventional LPDs.
Nutritional Adequacy of Essential Nutrients in Low Protein Animal-Based and Plant-Based Diets in the United States for Chronic Kidney Disease Patients. [2023]The nutritional adequacy of both animal-based and plant-based low protein diets (LPDs) and moderate protein diets that are recommended for patients with chronic kidney disease have not been well examined. We therefore analyzed the nutrient content of three representative LPDs and moderate protein diets (lacto-ovo vegetarian, omnivorous, and vegan) containing foods that are likely to be prescribed for nondialyzed chronic kidney disease or chronic dialysis patients in the United States to determine the nutritional adequacy at different levels of protein intake.