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
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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
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
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
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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
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.