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

Обзор

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.

Вмешательства

• Другое Predominantly 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
• Другое Standard 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.

Первичные конечные точки

• Adherence to diet - based on Good vs Moderate vs Poor Adherence [Срок оценки: 1 year]
• Acceptability of Diet [Срок оценки: 1 year]

Вторичные конечные точки (2)

• Serum Potassium level in mmol/L [Срок оценки: 1 year]
• Serum Bicarbonate Level (mmol/L) [Срок оценки: 1 year]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Сингапур · 1 центр

• Changi General Hospital — Singapore

Идентификаторы

NCT: NCT07544524 · 2025-1195

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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