Status:

NOT_YET_RECRUITING

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

Lead Sponsor:

National University of Malaysia

Conditions:

End Stage Renal Disease (ESRD)

End Stage Kidney Disease (ESRD)

Eligibility:

All Genders

18+ years

Phase:

NA

Brief 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 abo...

Detailed Description

End-stage renal disease (ESRD) is a growing health concern in Malaysia, with a significant increase in the proportion of patients receiving peritoneal dialysis (PD) from 13.0% in 2014 to 18% in 2023. ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 31 2026

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2026

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT07157397

Start Date

January 31 2026

End Date

December 31 2026

Last Update

January 7 2026

Active Locations (1)

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1

Hospital Canselor Tuanku Muhriz UKM

Cheras, Kuala Lumpur, Malaysia, 56000