The goal of this clinical trial is to determine whether a plant-focused diet improves nutritional and health outcomes of malnourished adults undergoing peritoneal dialysis (PD). It will also learn about the safety of this diet in this population.
The main questions it aims to answer are:
1. Does a plant-focused diet improve nutritional status compared to a standard kidney diet in PD patients? 2. What changes occur in anthropometric, biochemical, and dietary measures over 6 months?
Researchers will compare the plant-focused diet to a standard-of-care renal diet to see which is more effective in improving nutrition in PD patients.
Participants will:
* Be randomly assigned to follow the plant-focused diet or the standard diet. * Be monitored for 6 months through in-person visits (aligned with their routine clinic appointments) and virtual check-ins via messages or calls. * Have their progress monitored for changes in outcomes such as nutrition, blood tests, kidney function, and quality of life.
Adult outpatients (>18 years old), attending HTCM PD clinic visits
Have undergone peritoneal dialysis for at least 6 months
Have a serum albumin level <40 g/L
Have a BMI of < 25 kg/m2
Have been hospitalized for the past 3 months
Have ongoing infection/sepsis
Has undergone surgery in the past 6 months
Have high inflammatory diseases, malignancy, or cancer
Parallel
Plant-Focused Diet Counselling
BehavioralIndividualized dietary counseling conducted with the use of sample meal plans and infographics to guide patients to consume a diet emphasising plant-based protein sources while meeting nutritional requirements for peritoneal dialysis patients.
Standard Renal Diet Counselling
BehavioralIndividualized dietary counseling conducted with the use of sample meal plans and infographics based on current guideline recommendations, to guide patients to consume a diet emphasising animal-based protein sources while meeting nutritional requirements for peritoneal dialysis patients.
Changes in Dietary Adequacy
Dietary intake collected from analysis of 3-day dietary recalls (2 weekdays, 1 weekend), using Nutritionist Pro software. Dietary adequacy is assessed based on the comparison of each participant's macro- and micro-nutrient intakes against their estimated nutrient requirements. A deviation of more than 20% from the requirement will be classified as dietary inadequacy. Data will be summarised as percentage of participants meeting vs. not meeting adequacy.
Changes in Dialysis Adequacy
Dialysis adequacy will be assessed using weekly Kt/V (urea), obtained from patients' medical records. A total Kt/V \< 1.7 will be considered indicative of inadequate dialysis.
Changes in Concentration of Urea
A renal function parameter, measured in mmol/L, obtained from medical records. Results will be compared against standard laboratory reference ranges.
Changes in Concentration of Creatinine
A renal function parameter, measured in µmol/L, obtained from medical records. Results will be compared against standard laboratory reference ranges.
Changes in Weight
Post-dialysis weight will be measured in kilograms (kg), using a digital scale, with patients wearing light clothing and no heavy objects.
Height
Height will be measured in centimeters (cm), with patients standing straight on the stadiometer, following the Frankfurt horizontal plane.
Changes in Body mass index (BMI)
Body mass index will be calculated by dividing weight (kg) by the square of height (m²), recorded as kg/m².
Changes in Triceps skinfold (TSF)
Triceps skinfold will be assessed using skinfold callipers, recorded in centimetres (cm).
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MalaysiaClick on the lead sponsor to view all of their trials.
