Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Predominantly Plant-Based CKD Diet | Experimental |
| |
| Standard CKD Diet | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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.
| 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Estimated GFR (ml/min/1.73m2) decline | Change in Estimated GFR (ml/min/1.73m2) over 1 year will be calculated | 1 year |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changi General Hospital | Recruiting | Singapore | 529889 | Singapore |
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| 1 year |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| ID | Term |
|---|---|
| D001522 | Behavior, Animal |
| D001519 | Behavior |
Not provided
Not provided