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.

内容摘要

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 patients undergoing PD. However, randomized controlled trials remain limited, and the effectiveness of such diets in malnourished patients undergoing PD 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. This study aims to determine the effectiveness of a plant-focused dietary intervention compared with a standard-of-care renal diet on nutritional status, measured by changes in serum albumin, among malnourished patients undergoing PD over 6 months. This is an unblinded, open-label, parallel-group randomized controlled trial conducted at a tertiary care hospital in Klang. A total of 100 adult outpatients undergoing PD will be recruited and randomized (1:1) to receive either a plant-focused diet emphasizing plant-based proteins or a standard renal diet emphasizing animal-based proteins for 6 months. Both interventions will be individualized to meet nutrient requirements and delivered through dietitian-led counseling, 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; dietary adequacy; physical activity and function; quality of life; and knowledge, attitude, and practices of renal diet. Baseline data will be analyzed using descriptive statistics, with independent t tests (2-tailed) or Mann-Whitney U tests for between-group comparisons. Changes across time points will be analyzed using a generalized linear model for repeated measures, with Bonferroni adjustment for multiple comparisons. Analyses will be adjusted for confounders with significance set at P<.05. Ethics approval has been obtained from the Universiti Kebangsaan Malaysia Research Ethics Committee (JEP-2025-812). This study was funded in 2024 under the Geran Galakan Penyelidik Muda (project code: GGPM-2024-051) by Universiti Kebangsaan Malaysia. Participant recruitment began in March 2026, and 9 participants have been recruited as of manuscript submission. Study is expected to be completed by March 2027 Data analysis and manuscript preparation are anticipated to be completed by June 2027. This randomized controlled trial will provide clinical evidence on the nutritional and safety outcomes of a plant-focused diet in malnourished patients undergoing PD, addressing a major evidence gap in renal nutrition management. ClinicalTrials.gov NCT07157397; https://clinicaltrials.gov/study/NCT07157397 and National Medical Research Register NMRR ID-26-00114-LAK; https://nmrr.gov.my/research-directory/d0aad3f4-46ac-4498-8b75-f82f02209cec. PRR1-10.2196/93558.