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

NCT06871722 | Enrolling By Invitation

• 1 other identifier: Ramathibodi Ethic ID 6768
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Plant-based diet; kidney transplant recipient

Outcome Measures

Primary Outcomes (1)

• Difference change of blood pressure

  The difference in mean blood pressure change at 12 weeks from the baseline between the intervention and control groups.

  12 weeks

Secondary Outcomes (4)

• Gutmicrobiota

  12 weeks

• Kidney allograft function

  12 weeks

• Quality of life by 5EQ-5D-5L score

  12 weeks

• Kidney allograft function

  12 weeks

Study Arms (2)

Control

NO INTERVENTION

The normal diet for the control group is defined as a standard dietary intake without specific restrictions on protein sources. The dietary guidelines are as follows: 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, with no restrictions on the source of protein. Sodium Intake: Participants are encouraged to follow a low-sodium diet, limiting sodium intake to less than 2 g per day, in accordance with dietary recommendations for patients with chronic kidney disease (CKD).

Plant based diet

EXPERIMENTAL

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

Behavioral: Plant based diet

Interventions

Plant based diet BEHAVIORAL

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

Plant based diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Receive kidney transplantation after 6 months and before 18 months with a stable kidney allograft function defined by ≤ 25% change in an estimated glomerular filtration rate (eGFR) from the baseline eGFR at 3-month post-transplant for 2 consecutive values closest to the date of randomization. The most recent eGFR before randomization ≥ 30 ml/min/1.73 m2.
• An average SBP ≥ 130 and ≤ 160 mmHg at the time of randomization.
• No change in type and dose of antihypertensive medications ≥ 1 month before randomization or no initiation of new antihypertensive medication ≥ 1 month before randomization
• Anticipated to have no change in type and dose of antihypertensive medications during the 12-week study period.
• Can come to follow up per study protocol.

You may not qualify if:

• Combined solid organ transplantation
• Serum sodium \< 135 mmol/L before randomization
• Serum potassium \> 5.5 mmol/L before randomization
• History of acute kidney allograft rejection of the current kidney allograft

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Ramathibodi Hospial, 270 Rama VI Rd. Thung Phaya Thai, Ratchathewi

Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Hypertension

Interventions

Diet, Plant-Based

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A biostatistician will generate a random group assignment for participants and inform a research coordinator at the time of randomization. The research coordinator will then inform a RDN each patient's group assignment. Due to the nature of this study, only outcome assessors will be masked; while, patients, the biostatistician, a research coordinator, physicians, and a RDN will not be masked.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-center, single-blinded, 1:1 parallel randomized controlled trial. 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

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 12, 2025
• Study Start: April 29, 2025
• Primary Completion: November 26, 2025
• Study Completion: November 26, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)