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

National University of Malaysia1 个研究点分布在 1 个国家目标入组 100 人开始时间: 2026年3月10日最近更新: 2026年3月16日

干预措施

试验速览

阶段: 不适用
状态: 招募中
发起方
入组人数: 100
试验地点: 1
主要终点: Changes in Dietary Adequacy

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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 about the safety of this diet in this population.

The main questions it aims to answer are:

Does a plant-focused diet improve nutritional status compared to a standard kidney diet in PD patients?
What changes occur in anthropometric, biochemical, and dietary measures over 6 months?

Researchers will compare the plant-focused diet to a standard-of-care renal diet to see which is more effective in improving nutrition in PD patients.

Participants will:

Be randomly assigned to follow the plant-focused diet or the standard diet.
Be monitored for 6 months through in-person visits (aligned with their routine clinic appointments) and virtual check-ins via messages or calls.
Have their progress monitored for changes in outcomes such as nutrition, blood tests, kidney function, and quality of life.

详细描述

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. While PD offers certain clinical advantages, it is associated with common complications such as malnutrition and protein-energy wasting (PEW), which contribute to poor patient outcomes.

Emerging evidence suggests that plant-focused diets may have beneficial effects on nutritional status, inflammation, and metabolic complications in PD patients. However, data on their safety, efficacy, and long-term impact in this population remain limited. Hence, this study aims to address this research gap.

This study is a randomized, open-label clinical trial that will compare the effects of a plant-focused diet to a standard-of-care renal diet in malnourished PD patients over a 6-month period.

Participants will be recruited from Hospital Canselor Tuanku Muhriz (HCTM) UKM and randomized into two groups. Both groups will receive individualised dietary counselling and will be followed-up according to their assigned diet plan. Monitoring will occur through physical visits aligned with routine clinic visits, and through virtual check-ins (messages or phone calls). Key outcomes will be measured at baseline, 3 months, and 6 months.

The objectives of this study is:

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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

排除标准

•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

研究组 & 干预措施

Plant-Focused Diet

Experimental

Participants will receive individualised diet counselling and sample meal plans emphasizing plant-based protein sources while meeting recommended protein and energy requirements for peritoneal dialysis patients. Patients in this group will be required to consume plant-focused meals for the majority of their daily meals. For example, those consuming 3 meals per day must ensure that at least 2 out of the 3 meals are plant-based, while those consuming 4 meals per day must ensure that at least 3 out of the 4 meals are plant-based. The remaining meal or snack may include either plant- or animal-based foods to support flexibility and adherence. The diet will be tailored to each patient's nutritional status and dialysis prescription, with monthly follow-ups from a dietitian to monitor adherence and provide adjustments as needed.

干预措施: Plant-Focused Diet Counselling (Behavioral)

Standard-of-Care Renal Diet

Active Comparator

Participants will receive the current standard-of-care renal diet for peritoneal dialysis patients and be encouraged to maintain their usual dietary and physical activity patterns, with guidance to ensure that at least 50% of their total protein intake comes from high biological value (HBV) animal-based sources. The diet will be tailored to each patient's nutritional status and dialysis prescription, with monthly follow-ups from a dietitian to monitor adherence and provide adjustments as needed.

干预措施: Standard Renal Diet Counselling (Behavioral)

结局指标

主要结局

Changes in Dietary Adequacy

时间窗: At baseline, after 3 months of intervention, and after 6 months of intervention

Dietary intake collected from analysis of 3-day dietary recalls (2 weekdays, 1 weekend), using Nutritionist Pro software. Dietary adequacy is assessed based on the comparison of each participant's macro- and micro-nutrient intakes against their estimated nutrient requirements. A deviation of more than 20% from the requirement will be classified as dietary inadequacy. Data will be summarised as percentage of participants meeting vs. not meeting adequacy.

Changes in Dialysis Adequacy