Effect of a Plant-Focused Diet on Nutritional Status in Malnourished Peritoneal Dialysis Patients
Recruiting · NCT07157397 · Interventional (participants receive a specific treatment) · Lead sponsor: National University of Malaysia
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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 a malnutrition inflammation score (MIS) of mild, moderate or severe
- Agreed to follow the dietary instructions based on the randomization assignment
- Agreed to attend baseline visits and additional follow-up appointments at months 1, 3, and 6 post- randomization, either in person or via telehealth, and respond to monthly or more frequent phone calls
Exclusion criteria
- 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
- Have dialysis adequacy of \<1.2 Kt/V
Where it is running
1 location listed.
- Hospital Canselor Tuanku Muhriz UKM - Cheras, Kuala Lumpur, Malaysia