JMIR Publications

ABSTRACT

Background:

Malnutrition is a common and serious complication among patients undergoing peritoneal dialysis (PD), leading to poor clinical outcomes, reduced quality of life, and increased mortality. Although current renal dietary guidelines emphasize adequate protein intake, they are predominantly animal-based and may exacerbate inflammation and metabolic complications. Emerging evidence suggests that plant-focused diets can improve nutritional and inflammatory profiles without raising serum potassium levels. Increased plant consumption has also been associated with better metabolic control, reduced inflammation, and improved bowel function in PD patients. However, randomized controlled trials remain limited, and the effectiveness of such diets in malnourished PD patients is unclear. Hence, further investigation is required to evaluate the efficacy and safety of a plant-focused diet to inform evidence-based dietary recommendations in this population.

Objective:

This study aims to determine the effectiveness of a plant-focused dietary intervention compared to a standard-of-care renal dietary intervention on the nutritional status of malnourished patients undergoing peritoneal dialysis in a hospital care setting.

Methods:

This is an unblinded, open-label, parallel-group, randomized controlled trial conducted at a tertiary care hospital in Klang. A total of 100 adult PD outpatients will be recruited and randomized (1:1) to receive either a plant-focused diet emphasizing plant-based protein or a standard renal diet emphasizing animal-based protein for 6 months. Both interventions will be individualized to meet nutrient requirements and delivered through dietitian-led counselling, educational materials, and regular follow-ups. Data will be collected at baseline and after 3 and 6 months of intervention. Parameters assessed include sociodemographic characteristics, anthropometric and biochemical measures (renal, glucose, lipid, and inflammatory profiles), Malnutrition-Inflammation Score (MIS), dietary adequacy, physical activity and function, and quality of life. Baseline data will be analysed using descriptive statistics, with independent t-tests or Mann–Whitney U tests for between-group comparisons. Changes across time points will be analysed using a General Linear Model (GLM) for repeated measures, with Bonferroni adjustment for multiple comparisons. Analyses will be adjusted for confounders and significance set at p<0.05.

Results:

Ethical approval has been obtained from the Universiti Kebangsaan Malaysia Research Ethics Committee (Ethics reference number: JEP-2025-812). Recruitment is expected to begin in March 2026 and be concluded by November 2026. As of this protocol version, recruitment has yet to begin.

Conclusions:

This randomized controlled trial will provide clinical evidence on the nutritional and safety outcomes of a plant-focused diet in malnourished PD patients, addressing a major evidence gap in renal nutrition management. Clinical Trial: ClinicalTrials.gov Identifier: NCT07157397. National Medical Research Register Identifier: NMRR ID-26-00114-LAK.