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

RecruitingNAAges 18 Years - anyAllNational University of Malaysia
NCT07157397 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 p

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📋 Eligibility rules (as published)
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
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What it tests

  • Plant-Focused Diet Counselling
  • Standard Renal Diet Counselling
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Where

1 site
Hospital Canselor Tuanku Muhriz UKM
Cheras, Malaysia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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