Chronic Kidney Disease stage3NCT07544524
Feasibility, Safety and Efficacy of a Predominantly Plant-based Diet in an Asian Population With Chronic Kidney Disease
A study testing Predominantly Plant-Based CKD Diet and Standard CKD Diet in people with Chronic Kidney Disease stage3 and Chronic Kidney Disease stage4, run by Changi General Hospital at 1 site in Singapore.
Trial summary
This two-year follow up, single-center, open-label, feasibility study will recruit outpatients from the Renal Medicine Clinic at Changi General Hospital. Eligible patients with Stage 3 or 4 CKD will be assigned preferencebased to either a plant-based diet intervention (intake of at least 50% protein from plant… Read more about this study
- Who is it for?
- Ages 21 to 79 years
- Conditions the study is for
- Chronic Kidney Disease stage3, Chronic Kidney Disease stage4, Diet Habit
- What is being tested?
- Predominantly Plant-Based CKD Diet and Standard CKD Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Apr 2026to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21-79 (Only adults who can give consent will be recruited. Older adults aged 80 are not included to reduce the risk of confounding due to age-related frailty, sarcopenia and multimorbidity. Additionally, older adults may have different nutritional needs and energy requirements)
- CKD stage 3-4 (baseline eGFR 15-60ml/min/1.72m2 for the past 6 months)
- Willingness to see a dietitian and follow either a standard CKD diet or a predominantly plant-based CKD diet
- On maximum tolerated dose of ACE-inhibitors (Angiotensin converting enzyme inhibitors) or ARB (Aldosterone receptor blocker) as determined by Renal Physician in charge
- Able to provide informed consent
Who cannot join
- Transplant patients (who will tend to have more variable trajectories, immunosuppression related challenges etc which may make this study less feasible)
- Pregnant or lactating patients (who have different nutritional requirements than the standard CKD patients)
- Patients who were on any special diet for at least 1 month prior to recruitment (inclusive of
- long-term vegans or vegetarians) - excluded because they already have stable dietary habits
- Age <21 or >/= 80 (Avoid growing children who have different nutritional requirements and advanced elderly who are more likely to have malnutrition or sarcopenia due to other pre-existing causes)
- Those who have seen a dietitian for CKD previously
Show all 12Show fewer
- Patients with severe ischemic heart disease, decompensated liver cirrhosis, malabsorptive diseases or malignancy
- Patients with BMI <18.5 or >40
- Patients with glomerulonephritis, genetic kidney disease or polycystic kidney disease
- Baseline serum potassium 5.0 and above
- Patients who are unable to modify their diet due to socio-economic issues.
- Exclude patients with acute kidney injury (AKI) in the past 6 months prior to study (unstable renal disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
Changi General Hospital
Singapore, 529889
Saradha Anantharaman, MBBS, MMed Internal Medicine, 96749651, anantharaman.saradha@singhealth.com.sg
About this study
This two-year follow up, single-center, open-label, feasibility study will recruit outpatients from the Renal Medicine Clinic at Changi General Hospital. Eligible patients with Stage 3 or 4 CKD will be assigned preferencebased to either a plant-based diet intervention (intake of at least 50% protein from plant sources) with regular dietitian counselling and follow up, or a control group receiving dietitian counselling for general CKD dietary advice without information on percentage of plant-based foods. Six monthly assessments will include estimated glomerular filtration rate (eGFR), serum potassium, nutritional markers, and other relevant biochemical parameters. Quality of life and dietary adherence will be evaluated through questionnaires and food frequency records. This study will evaluate primarily, the feasibility of a plant-based diet in the Singaporean context. Secondarily it will evaluate its safety in terms of incidence of hyperkalaemia, and benefit in terms of improvement in acidosis.
Other exploratory outcomes will include (1) preliminary efficacy of plant-based diets on CKD progression (measured by eGFR decline); (2) risk of nutritional deficiencies such as vitamin D, B12 and iron; and (3) impact on other biochemical parameters of CKD.
- Being tested
- Predominantly Plant-Based CKD Diet, Standard CKD Diet
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Predominantly Plant-Based CKD DietOther
Subjects in the intervention group will receive personalised dietary advice \& educational materials from a renal dietitian for retarding CKD progression (low salt, moderate protein) with additional focus on including more non-/minimally processed plant-based foods. Food recommended would be those easily obtained
Standard CKD DietOther
Subjects in the control arm will receive advice from a renal dietician for general healthy eating for retarding CKD progression (low salt, low-moderate protein intake). No specific advice on percentage of protein intake contributed to by plant-based protein will be given.
| Study group | Role | What they receive |
|---|---|---|
| Predominantly Plant-Based CKD Diet | Experimental | Not described Receives: Other: Predominantly Plant-Based CKD Diet |
| Standard CKD Diet | Active comparator | Not described Receives: Other: Standard CKD Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to diet - based on Good vs Moderate vs Poor Adherence
Percentage adherence will be assessed independently by the dietician and investigator seeing the patient, then averaged.
- Where there is a >10% difference in assessment between dietician and investigator, the results will be discussed, and a combined decision will be made on adherence level
- >75% adherence - "Good Adherence"
- 50-75% - "Moderate Adherence"
- <50% - "Poor Adherence"
Measured: 1 year
Acceptability of Diet
Acceptability of diet via Diet, palatability and appetite questionnaire. In the absence of a validated cut-off score, acceptability will be assessed based on the proportion of positive versus negative responses to each item in the Diet, Palatability, and Appetite Questionnaire. A higher porportion of positive responses suggests a more accepatable diet. >50% positive responses will indicate an acceptable diet while < 50% of positive responses will indicate an unacceptable diet.
Measured: 1 year
Secondary outcomes (2)
Serum Potassium level in mmol/L
Potassium will be measured in mmol/L. Hyperkalaemia will be defined as serum potassium level > 5.3 mmol/L
Measured: 1 year
Serum Bicarbonate Level (mmol/L)
Absolute serum bicarbonate level (mmol/L) will be measured. Metabolic acidosis will be defined as serum bicarbonate level < 20 mmol/L.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease stage3Studies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07544524
- Sponsor's protocol ID
- 2025-1195
- Status last verified
- Mar 2026
- First submitted
- 31 Mar 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data (IPD) sharing is currently undecided. A data sharing plan will be developed at a later stage in accordance with institutional policies and applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Safety and Efficacy of a Predominantly Plant-based Diet in an Asian Population With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT07544524
- Acronym / sponsor ID
- 2025-1195
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 22 Apr 2026 (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.
This two-year follow up, single-center, open-label, feasibility study will recruit outpatients from the Renal Medicine Clinic at Changi General Hospital. Eligible patients with Stage 3 or 4 CKD will be assigned preferencebased to either a plant-based diet intervention (intake of at least 50% protein from plant sources) with regular dietitian counselling and follow up, or a control group receiving dietitian counselling for general CKD dietary advice without information on percentage of plant-based foods. Six monthly assessments will include estimated glomerular filtration rate (eGFR), serum potassium, nutritional markers, and other relevant biochemical parameters. Quality of life and dietary adherence will be evaluated through questionnaires and food frequency records. This study will evaluate primarily, the feasibility of a plant-based diet in the Singaporean context. Secondarily it will evaluate its safety in terms of incidence of hyperkalaemia, and benefit in terms of improvement in acidosis.
Other exploratory outcomes will include (1) preliminary efficacy of plant-based diets on CKD progression (measured by eGFR decline); (2) risk of nutritional deficiencies such as vitamin D, B12 and iron; and (3) impact on other biochemical parameters of CKD.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Predominantly Plant-Based CKD Diet | Experimental | Other: Predominantly Plant-Based CKD Diet |
| Standard CKD Diet | Active comparator | Other: Standard CKD Diet |
Who may qualify
- Ages
- 21 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 21-79 (Only adults who can give consent will be recruited. Older adults aged 80 are not included to reduce the risk of confounding due to age-related frailty, sarcopenia and multimorbidity. Additionally, older adults may have different nutritional needs and energy requirements)
- CKD stage 3-4 (baseline eGFR 15-60ml/min/1.72m2 for the past 6 months)
- Willingness to see a dietitian and follow either a standard CKD diet or a predominantly plant-based CKD diet
- On maximum tolerated dose of ACE-inhibitors (Angiotensin converting enzyme inhibitors) or ARB (Aldosterone receptor blocker) as determined by Renal Physician in charge
- Able to provide informed consent
Key exclusion criteria (12 listed)
- Transplant patients (who will tend to have more variable trajectories, immunosuppression related challenges etc which may make this study less feasible)
- Pregnant or lactating patients (who have different nutritional requirements than the standard CKD patients)
- Patients who were on any special diet for at least 1 month prior to recruitment (inclusive of
- long-term vegans or vegetarians) - excluded because they already have stable dietary habits
- Age <21 or >/= 80 (Avoid growing children who have different nutritional requirements and advanced elderly who are more likely to have malnutrition or sarcopenia due to other pre-existing causes)
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 |
|---|---|---|
| Predominantly Plant-Based CKD DietSubjects in the intervention group will receive personalised dietary advice \& educational materials from a renal dietitian for retarding CKD progression (low salt, moderate protein) with additional focus on including more non-/minimally processed plant-based foods. Food recommended would be those easily obtained | Other | Predominantly Plant-Based CKD Diet |
| Standard CKD DietSubjects in the control arm will receive advice from a renal dietician for general healthy eating for retarding CKD progression (low salt, low-moderate protein intake). No specific advice on percentage of protein intake contributed to by plant-based protein will be given. | Other | Standard CKD Diet |
Primary outcome
Adherence to diet - based on Good vs Moderate vs Poor Adherence
Time frame: 1 year
Percentage adherence will be assessed independently by the dietician and investigator seeing the patient, then averaged. * Where there is a >10% difference in assessment between dietician and investigator, the results will be discussed, and a combined decision will be made on adherence level * >75% adherence - "Good Adherence" * 50-75% - "Moderate Adherence" * <50% - "Poor Adherence"
Acceptability of Diet
Time frame: 1 year
Acceptability of diet via Diet, palatability and appetite questionnaire. In the absence of a validated cut-off score, acceptability will be assessed based on the proportion of positive versus negative responses to each item in the Diet, Palatability, and Appetite Questionnaire. A higher porportion of positive responses suggests a more accepatable diet. >50% positive responses will indicate an acceptable diet while < 50% of positive responses will indicate an unacceptable diet.
2 secondary outcomes
Serum Potassium level in mmol/L
Time frame: 1 year
Serum Bicarbonate Level (mmol/L)
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: Undecided. Individual participant data (IPD) sharing is currently undecided. A data sharing plan will be developed at a later stage in accordance with institutional policies and applicable regulations.
Related trials for Chronic Kidney Disease stage3
Recruiting
Effect of Synbiotic Therapy on Renal Function Outcomes in Patients With Chronic Kidney Disease Stage III-IV: A Double-blind Randomized Placebo-controlled Trial.
Chronic Kidney Disease (Stage 3-4)
Enrolling by invitationObservational study
AK+ Guard™ Pilot Study in Chronic Kidney Disease: Outpatient Diagnostic Accuracy and Remote Monitoring
Hyperkalemia, Chronic Kidney Disease (Stage 3-4)
Active, not recruitingObservational study
Metabolic Status and Risk of Chronic Kidney Disease in French Overseas Populations With Morbid Obesity (OBECAMcohort).
Morbid Obesity, Chronic Kidney Disease (Stage 3-4)
Recruiting
Prospective Analysis of Self Medication With Phytotherapy in Nephropatic Patients.
Chronic Kidney Disease (Stage 3-4), Chronic Kidney Disease (Stages 4 and 5)
RecruitingPhase 2
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability Evaluation of CTAP101 Extended-release Capsules in Pediatric Participants
CKD Stage 3, CKD Stage 4
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Predominantly Plant-Based CKD Diet and Standard CKD Diet in people with Chronic Kidney Disease stage3 and Chronic Kidney Disease stage4, run by Changi General Hospital at 1 site in Singapore.
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 12 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: looking for participants now, as of the sponsor's last update on 22 Apr 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 Singapore. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to diet - based on Good vs Moderate vs Poor Adherence (time frame: 1 year). The study lists 2 primary outcomes in all. 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 22 Apr 2026.