How a Plant-Based Diet Affects Blood Pressure and Gut Health in Kidney Transplant Patient
NCT06871722 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102
Last updated 2025-05-21
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, single-blinded, 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 6 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.
Conditions
- Hypertension
- Gut -Microbiota
- Kidney Function
- Quality of Life (QOL)
Interventions
- BEHAVIORAL
-
Plant based diet
The plant-based diet in this study is defined as a predominantly vegetarian dietary pattern, consisting of two vegetarian meals per day and one meal that includes animal-derived protein. The diet is based on whole foods while avoiding ultra-processed foods. Macronutrient Composition Caloric Intake: 30-35 kcal per kilogram of body weight per day Protein Intake: 0.8-1 g per kilogram of body weight per day Fat Sources Animal-derived fats are to be avoided. Plant-based oils are recommended as the primary source of dietary fats. Protein Sources Emphasis is placed on plant-based protein sources, including nuts, beans, edamame, tofu, and tempeh. Dairy consumption is permitted, but cow's milk is discouraged. Instead, plant-based alternatives such as almond milk and soy-based milk (e.g., tofu milk) are recommended. Egg consumption is allowed but limited to no more than one egg per day
Sponsors & Collaborators
-
Mahidol University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-04-29
- Primary Completion
- 2025-11-26
- Completion
- 2025-11-26
Countries
- Thailand
Study Locations
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