Clinical Trial

How a Plant-Based Diet Affects Blood Pressure and Gut Health in Kidney Transplant Patient

Study acronym: PLANET-KT
Completed
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Summary
Kidney transplant improves the quality of life (QoL) and survival of appropriate patients with advanced chronic kidney disease (CKD) and end-stage kidney disease (ESKD). However, these patients still have higher mortality compared to the general population and cardiovascular disease (CVD) is the leading cause of mortality. Among several metabolic complications post-transplantation, hypertension is one of the common risk factors for CVD. In addition to cardiometabolic alteration post-transplant, there is often observed gut microbial dysbiosis, marked by a decrease in microbial diversity and an increase in the relative abundance of Proteobacteria compared to individuals in a healthy state. Different dietary patterns can lead to distinct gut microbiota compositions. Diets rich in plant-based foods, whole grains, fruits, and vegetables tend to promote a more diverse and beneficial gut microbiota characterized by a higher abundance of fiber-degrading bacteria. On the other hand, diets high in saturated fats, refined sugars, and processed foods have been associated with dysbiosis, characterized by a reduction in beneficial bacteria and an overgrowth of potentially harmful microbes. While there is data in the normal population suggesting that a healthy diet can alter gut microbiota composition, the impact of a plant-based diet on gut microbiota-associated hypertension in kidney transplant recipients remains understudied. To address this gap, the investigators propose a single-center, open-label, 1:1 parallel randomized controlled trial to examine the effect of consuming a plant-based diet (intervention group) for 12 weeks on the change in blood pressure, gut microbiota, and patient report outcomes compared to the habitual diet (control group) in kidney transplant recipients with stable kidney allograft function at least 3 months post-transplantation. The investigators hypothesize that the adoption of a plant-based diet decreases in blood pressure, induces significant changes in gut microbiota composition and does not change in QoL.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2025-03-06; most recent amendment 2026-06-08.
Status change: Enrolling by Invitation → Completed 2026-06-08
Trial Details
NCT Number NCT06871722
Lead Sponsor Mahidol University
Conditions Hypertension, Gut -Microbiota, Kidney Function, Quality of Life (QOL)
Enrollment 102 participants
Start Date 2025-04-29
Primary Completion 2025-11-26 (estimated)
Study Completion 2025-11-26 (estimated)
Updated on ClinicalTrials.gov 2026-06-10