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Effect of Plant-Focused Diet on Nutritional Status of Malnourished Patients Undergoing Peritoneal Dialysis in a Selected Hospital Care Setting

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Malaysia
Hospital Canselor Tuanku Muhriz UKM
RECRUITING
Cheras
Contact Information
Primary
Dr. Harvinder Kaur A/P Gilcharan Singh
harvinder_kaur@ukm.edu.my
+60125902925
Backup
Qiao Qian Soon
s.qiaoqian@gmail.com
+60126553396
Time Frame
Start Date: 2026-03-10
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 100
Treatments
Experimental: Plant-Focused Diet
Participants will receive individualised diet counselling and sample meal plans emphasizing plant-based protein sources while meeting recommended protein and energy requirements for peritoneal dialysis patients. Patients in this group will be required to consume plant-focused meals for the majority of their daily meals. For example, those consuming 3 meals per day must ensure that at least 2 out of the 3 meals are plant-based, while those consuming 4 meals per day must ensure that at least 3 out of the 4 meals are plant-based. The remaining meal or snack may include either plant- or animal-based foods to support flexibility and adherence. The diet will be tailored to each patient's nutritional status and dialysis prescription, with monthly follow-ups from a dietitian to monitor adherence and provide adjustments as needed.
Active_comparator: Standard-of-Care Renal Diet
Participants will receive the current standard-of-care renal diet for peritoneal dialysis patients and be encouraged to maintain their usual dietary and physical activity patterns, with guidance to ensure that at least 50% of their total protein intake comes from high biological value (HBV) animal-based sources. The diet will be tailored to each patient's nutritional status and dialysis prescription, with monthly follow-ups from a dietitian to monitor adherence and provide adjustments as needed.
Related Therapeutic Areas
Sponsors
Leads: National University of Malaysia

This content was sourced from clinicaltrials.gov