HypertensionPLANET-KTNCT06871722
How a Plant-Based Diet Affects Blood Pressure and Gut Health in Kidney Transplant Patient
A study testing Plant based diet in people with Hypertension and Gut -Microbiota, run by Mahidol University at 1 site in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Gut -Microbiota, Kidney Function
- What is being tested?
- Plant based diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteThailand
- Study dates
- 29 Apr 2025to 26 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Receive kidney transplantation at least 3 months before enrollment with 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 ≥ 120 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.
- Able to attend follow-up visits according to the study protocol.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Ramathibodi Hospital, 270 Rama VI Rd. Thung Phaya Thai, Ratchathewi
Bangkok, 10400
About this study
Official title: Effect of Plant-based Diet on Blood Pressure and Gut Microbiota in Kidney Transplant Recipients
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.
Read the detailed description
Kidney transplantation is the best therapeutic option for patients with advanced CKD and ESKD. It significantly improves quality of life and survival. However, kidney transplant recipients remain facing higher mortality compared to the general population. Similar to the non-transplant population, cardiovascular disease (CVD) is the most common cause of mortality in kidney transplant recipients and hypertension is one of the most common risk factors for CVD. While a plant-based diet is associated with improved blood pressure control, there is a lack of evidence of the benefit of a plant-based diet in kidney transplant recipients. Recently, the gut microbiota has emerged, and the impact appears to be bidirectional. Gut microbiota participates in various effects in the human body such as the synthesis of vitamins, production of short-chain fatty acids, degradation of plant polysaccharides, and immune system development. In CKD, there is alteration in gut microbiota most notably as decrease in the Lactobacillaceae and Prevotellaceae families. After successful kidney transplantation, gut microbial dysbiosis has also been observed and typically characterized by a decrease in microbial diversity and an increase in the relative prevalence of Proteobacteria in comparison to individuals with normal health. Evidence has demonstrated the association of gut microbiota on kidney transplant outcomes such as hypertension, allograft rejection, immunosuppressant metabolism, and post-transplant infection. Therefore, dietary intervention is one of the non-pharmacologic options that can modify and change gut microbiota.
Several types of plant-based diets are associated with beneficial effects on kidney transplant outcomes. For instance, Mediterranean diet is associated with a lower incidence of metabolic syndrome. Dietary Approaches to Stop Hypertension (DASH) diet is associated with a lower risk of kidney allograft function decline and all-cause mortality. Studies have shown the interaction among plant-based dietary consumption, gut microbiota composition, and blood pressure. Although these dietary patterns-related clinical outcomes are associated with improved gut microbiota in kidney transplant recipients, there is a lack of data about the association between consuming plant-based diet, change in gut microbiota, and blood pressure control in kidney transplant recipients. Therefore, the investigators hypothesize that plant-based diet consumption improves blood pressure control and gut microbiota; while, does not decrease the quality of life in kidney transplant recipients
- Conditions
- Hypertension, Gut -Microbiota, Kidney Function, Quality of Life (QOL)
- Being tested
- Plant based diet
- Keywords
- Plant-based diet, kidney transplant recipient
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant based dietBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Plant based diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference change of blood pressure
The difference in mean blood pressure change at 12 weeks from the baseline between the intervention and control groups.
Measured: 12 weeks
Secondary outcomes (4)
Gutmicrobiota
The difference in gut microbiota composition between the two groups at 12 weeks from baseline, as determined by 16S rRNA sequencing from stool and 3 parameters including alpha diversity, beta diversity, and gut bacterial profile and composition will be evaluated.
Measured: 12 weeks
Kidney allograft function
Change in kidney allograft function between the intervention and control groups, assessed using serum creatinine.
Measured: 12 weeks
Quality of life by 5EQ-5D-5L score
Change in quality of life assessed by 5EQ-5D-5L between intervention and control groups
Measured: 12 weeks
Kidney allograft function
Change in kidney allograft function between the intervention and control groups, assessed using eGFR.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start29 Apr 2025
- Primary completion26 Nov 2025
- Study completion26 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-center, open-label, 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
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Surasak Kantachuvesiri, M.D, Ph.D., Study chair, Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06871722
- Sponsor's protocol ID
- Ramathibodi Ethic ID 6768
- Acronym
- PLANET-KT
- Status last verified
- Jun 2026
- First submitted
- 6 Mar 2025
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) from this study will not be shared. This decision is made to protect participant confidentiality and ensure compliance with institutional and ethical guidelines regarding data privacy
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Plant-based Diet on Blood Pressure and Gut Microbiota in Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT06871722
- Acronym / sponsor ID
- PLANET-KT / Ramathibodi Ethic ID 6768
- Conditions
- Hypertension, Gut -Microbiota, Kidney Function, Quality of Life (QOL)
- Keywords
- Plant-based diet, kidney transplant recipient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 29 Apr 2025 (actual)
- Primary completion
- 26 Nov 2025 (actual)
- Study completion
- 26 Nov 2025 (actual)
- First posted
- 12 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Kidney transplantation is the best therapeutic option for patients with advanced CKD and ESKD. It significantly improves quality of life and survival. However, kidney transplant recipients remain facing higher mortality compared to the general population. Similar to the non-transplant population, cardiovascular disease (CVD) is the most common cause of mortality in kidney transplant recipients and hypertension is one of the most common risk factors for CVD. While a plant-based diet is associated with improved blood pressure control, there is a lack of evidence of the benefit of a plant-based diet in kidney transplant recipients. Recently, the gut microbiota has emerged, and the impact appears to be bidirectional. Gut microbiota participates in various effects in the human body such as the synthesis of vitamins, production of short-chain fatty acids, degradation of plant polysaccharides, and immune system development. In CKD, there is alteration in gut microbiota most notably as decrease in the Lactobacillaceae and Prevotellaceae families. After successful kidney transplantation, gut microbial dysbiosis has also been observed and typically characterized by a decrease in microbial diversity and an increase in the relative prevalence of Proteobacteria in comparison to individuals with normal health. Evidence has demonstrated the association of gut microbiota on kidney transplant outcomes such as hypertension, allograft rejection, immunosuppressant metabolism, and post-transplant infection. Therefore, dietary intervention is one of the non-pharmacologic options that can modify and change gut microbiota.
Several types of plant-based diets are associated with beneficial effects on kidney transplant outcomes. For instance, Mediterranean diet is associated with a lower incidence of metabolic syndrome. Dietary Approaches to Stop Hypertension (DASH) diet is associated with a lower risk of kidney allograft function decline and all-cause mortality. Studies have shown the interaction among plant-based dietary consumption, gut microbiota composition, and blood pressure. Although these dietary patterns-related clinical outcomes are associated with improved gut microbiota in kidney transplant recipients, there is a lack of data about the association between consuming plant-based diet, change in gut microbiota, and blood pressure control in kidney transplant recipients. Therefore, the investigators hypothesize that plant-based diet consumption improves blood pressure control and gut microbiota; while, does not decrease the quality of life in kidney transplant recipients
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a single-center, open-label, 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
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Plant based dietThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Receive kidney transplantation at least 3 months before enrollment with 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 ≥ 120 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.
- Able to attend follow-up visits according to the study protocol.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plant based dietThe 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 | Behavioural | Plant based diet |
Primary outcome
Difference change of blood pressure
Time frame: 12 weeks
The difference in mean blood pressure change at 12 weeks from the baseline between the intervention and control groups.
4 secondary outcomes
Gutmicrobiota
Time frame: 12 weeks
Kidney allograft function
Time frame: 12 weeks
Quality of life by 5EQ-5D-5L score
Time frame: 12 weeks
Kidney allograft function
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) from this study will not be shared. This decision is made to protect participant confidentiality and ensure compliance with institutional and ethical guidelines regarding data privacy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Surasak Kantachuvesiri, M.D, Ph.D. study chair
Ramathibodi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plant based diet in people with Hypertension and Gut -Microbiota, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference change of blood pressure (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.