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NCT Number: NCT07544524

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

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.

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Key information

Conditions

Chronic Kidney Disease stage3 Behavior Behavior, Animal Chronic Kidney Disease stage4 Diet Habit Feeding Behavior

Age range

21 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changi General Hospital

Singapore, 529889

Location status: Recruiting

Location contact

Saradha Anantharaman, MBBS, MMed Internal Medicine

CONTACT

[email protected]

96749651

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Predominantly Plant-Based CKD Diet

Other

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 Diet

Other

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.

Primary outcomes

  1. 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"

  2. 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.

Secondary outcomes

  1. Serum Potassium level in mmol/L

    Time frame: 1 year

    Potassium will be measured in mmol/L. Hyperkalaemia will be defined as serum potassium level > 5.3 mmol/L

  2. Serum Bicarbonate Level (mmol/L)

    Time frame: 1 year

    Absolute serum bicarbonate level (mmol/L) will be measured. Metabolic acidosis will be defined as serum bicarbonate level < 20 mmol/L.

Other outcomes

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

    Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

Changi General Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 22, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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