Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07157397

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

Led by National University of Malaysia · Updated on 2026-03-16

100

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate whether a plant-focused diet improves nutritional and health outcomes in malnourished adults undergoing peritoneal dialysis (PD). The study addresses the safety and effectiveness of this diet compared to the standard kidney diet, focusing on nutrition, inflammation, and metabolic complications in PD patients. It is a randomized, open-label clinical trial conducted over six months. Participants will be randomly assigned to one of two groups: one following a plant-focused diet with individualized counseling emphasizing plant-based protein sources, and the other following the standard renal diet emphasizing animal-based protein sources. Both diets are tailored to meet nutritional needs for PD patients, with monthly dietitian follow-ups to monitor adherence and make adjustments. The plant-focused group is encouraged to consume mostly plant-based meals, while the standard diet group maintains usual dietary patterns. Participants will attend baseline visits and follow-ups at 1, 3, and 6 months, either in person or via telehealth, with additional monthly phone check-ins. Researchers will assess changes in dietary adequacy, dialysis adequacy, kidney function, nutritional status, inflammation, physical function, quality of life, and adherence to the diet. Various measures such as blood tests, anthropometric data, dietary questionnaires, and physical function tests will be collected to evaluate the outcomes and safety of the diets.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult outpatients over 18 years old attending peritoneal dialysis clinic visits
  • Have undergone peritoneal dialysis for at least 6 months
  • Serum albumin level less than 40 g/L
  • Body mass index (BMI) less than 25 kg/m2
  • Malnutrition inflammation score (MIS) of mild, moderate, or severe
  • Agree to follow dietary instructions based on group assignment
  • Agree to attend baseline and follow-up visits at months 1, 3, and 6, either in person or via telehealth, and respond to phone calls
Not Eligible

You will not qualify if you...

  • Hospitalized within the past 3 months
  • Have ongoing infection or sepsis
  • Had surgery in the past 6 months
  • Have high inflammatory diseases, malignancy, or cancer
  • Dialysis adequacy less than 1.2 Kt/V

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or telehealth) to assess eligibility and baseline measurements

Treatment

Duration - 6 months

Participants receive individualized diet counselling to follow either a plant-focused diet or the standard renal diet tailored to their nutritional needs and dialysis prescription.

Monthly visits with a dietitian for diet counselling and adherence monitoring, plus routine clinic visits and virtual check-ins (messages or phone calls)

Follow-up

Duration - 6 months concurrent with treatment

Participants are monitored through scheduled assessments to evaluate changes in nutritional status, biochemical markers, physical function, and quality of life.

Assessments at baseline, 3 months, and 6 months during scheduled visits

Trial Site Locations

Total: 1 location

1

Hospital Canselor Tuanku Muhriz UKM

Cheras, Kuala Lumpur, Malaysia, 56000

Actively Recruiting

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Research Team

D

Dr. Harvinder Kaur A/P Gilcharan Singh

Q

Qiao Qian Soon

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Effects of a Plant-Focused Diet on the Nutritional Status of Malnourished Patients Undergoing Peritoneal Dialysis in a Selected Hospital Care Setting: Protocol for an Open-Label, Parallel-Group, Randomized Controlled Trial.

Qiao Qian Soon, Harvinder Kaur Gilcharan Singh, Sharmela Sahathevan...

https://pubmed.ncbi.nlm.nih.gov/42117602