ClinicalTrials.gg
RecruitingNCT07544524Updated Apr 22, 2026

Feasibility, Safety and Efficacy of a Predominantly Plant-based Diet in an Asian Population With Chronic Kidney Disease

An interventional study of Predominantly Plant-Based CKD Diet and Standard CKD Diet in Chronic Kidney Disease stage3, Chronic Kidney Disease stage4 and Diet Habit, sponsored by Changi General Hospital. Recruiting at 1 site in Singapore. Open to participants aged 21 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-04-22.

Sponsored by Changi General Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
21 Years to 79 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Chronic Kidney Disease stage3
  • Chronic Kidney Disease stage4
  • Diet Habit

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03

In context

Feeding Behavior

985 studies on the registry are indexed under Feeding Behavior; 178 are open to participants now.

This study's planned enrollment of 40 is below the median of 77 across 700 interventional studies indexed under Feeding Behavior.

Browse Feeding Behavior studies →

Lead sponsor

Changi General Hospital is the lead sponsor of 101 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 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)
  2. CKD stage 3-4 (baseline 15-60ml/min/1.72m2 for the past 6 months)
  3. Willingness to see a dietitian and follow either a standard CKD diet or a predominantly plant-based CKD diet
  4. On maximum tolerated dose of ACE-inhibitors (Angiotensin converting enzyme inhibitors) or ARB (Aldosterone receptor blocker) as determined by Renal Physician in charge
  5. Able to provide

Exclusion criteria

Exclusion Criteria:

  • Transplant patients (who will tend to have more variable trajectories, 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
  • Patients with severe ischemic heart disease, decompensated liver cirrhosis, malabsorptive diseases or
  • Patients with \<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
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Predominantly Plant-Based CKD Diet

    Other: Predominantly Plant-Based CKD Diet

  • Active comparator
    Standard CKD Diet

    Other: Standard CKD Diet

Interventions

  • OtherPredominantly Plant-Based CKD Diet

    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

  • OtherStandard CKD Diet

    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.

06

What researchers measure

Primary outcomes

  1. 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"

    Time frame: 1 year

  2. 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.

    Time frame: 1 year

Secondary outcomes

  1. 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

    Time frame: 1 year

  2. 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.

    Time frame: 1 year

Other outcomes

  1. Estimated GFR (ml/min/1.73m2) decline

    Change in Estimated GFR (ml/min/1.73m2) over 1 year will be calculated

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07544524
Responsible party
Sponsor
First posted
Apr 22, 2026
Start date
Apr 1, 2026 (estimated)
Primary completion
Sep 30, 2027 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Apr 22, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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