RecruitingNot ApplicableNCT07157397

Effect of a Plant-Focused Diet on Nutritional Status in Malnourished Peritoneal Dialysis Patients

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


Sponsor

National University of Malaysia

Enrollment

100 participants

Start Date

Mar 10, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria7

  • 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 Criteria5

  • 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

Interventions

BEHAVIORALPlant-Focused Diet Counselling

Individualized 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.

BEHAVIORALStandard Renal Diet Counselling

Individualized 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.


Locations(1)

Hospital Canselor Tuanku Muhriz UKM

Cheras, Kuala Lumpur, Malaysia

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NCT07157397


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