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

Официальное название

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

Обзор

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: 1. Does a plant-focused diet improve nutritional status compared to a standard kidney diet in PD patients? 2. 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.

Подробное описание

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:

1. To assess the baseline nutritional status of PD patients in relation to their dietary knowledge, attitude, and practice (KAP), sociodemographic and medical history, anthropometric measurements, biochemical and dietary data, malnutrition-inflammation score (MIS), physical function, quality of life (QOL), and appetite. 2. To compare changes in primary outcomes consisting of dietary adequacy, dialysis adequacy, and kidney function, between groups after 3 and 6 months of intervention. 3. To compare changes in secondary outcomes consisiting of anthropometric measurements, biochemical data, inflammatory markers, adherence to the dietary regime, MIS, physical function, QOL, appetite, and retention rate, between groups after 3 and 6 months.

The findings of this trial may provide important evidence to guide nutritional recommendations for PD patients, improve nutritional outcomes, and address common misconceptions that may contribute to poor dietary intake in this population.

Вмешательства

• Поведенческое Plant-Focused Diet Counselling
  Individualized dietary counseling conducted with the use of sample meal plans and infographics to guide patients to consume a diet emphasising plant-based protein sources while meeting nutritional requirements for peritoneal dialysis patients.
• Поведенческое Standard Renal Diet Counselling
  Individualized dietary counseling conducted with the use of sample meal plans and infographics based on current guideline recommendations, to guide patients to consume a diet emphasising animal-based protein sources while meeting nutritional requirements for peritoneal dialysis patients.

Первичные конечные точки

• Changes in Dietary Adequacy [Срок оценки: At baseline, after 3 months of intervention, and after 6 months of intervention]
• Changes in Dialysis Adequacy [Срок оценки: At baseline, after 3 months of intervention, and after 6 months of intervention.]
• Changes in Concentration of Urea [Срок оценки: At baseline, after 3 months of intervention, and after 6 months of intervention.]
• Changes in Concentration of Creatinine [Срок оценки: At baseline, after 3 months of intervention, and after 6 months of intervention.]
• Changes in Concentration of Sodium [Срок оценки: At baseline, after 3 months of intervention, and after 6 months of intervention.]
• Changes in Concentration of Potassium [Срок оценки: At baseline, after 3 months of intervention, and after 6 months of intervention.]
• Changes in Concentration of Phosphate [Срок оценки: At baseline, after 3 months of intervention, and after 6 months of intervention.]
• Changes in Concentration of Serum Albumin [Срок оценки: At baseline, after 3 months of intervention, and after 6 months of intervention.]
• Changes in Concentration of Total Protein [Срок оценки: At baseline, after 3 months of intervention, and after 6 months of intervention.]

Вторичные конечные точки (12)

• Changes in Weight [Срок оценки: At baseline, after 3 months of intervention, and after 6 months of intervention.]
• Height [Срок оценки: At baseline, after 3 months of intervention, and after 6 months of intervention.]
• Changes in Body mass index (BMI) [Срок оценки: At baseline, after 3 months of intervention, and after 6 months of intervention.]
• Changes in Triceps skinfold (TSF) [Срок оценки: At baseline, after 3 months of intervention, and after 6 months of intervention.]
• Changes in Dietary Adherence/Compliance [Срок оценки: Baseline and monthly, for up to 6 months.]
• Changes in Malnutrition-Inflammation Score (MIS) [Срок оценки: At baseline, after 3 months of intervention, and after 6 months of intervention.]
• Changes in Appetite and Food Satisfaction (AFSQ) [Срок оценки: At baseline, after 3 months of intervention, and after 6 months of intervention.]
• Changes in Quality of life (WHOQOL-BREF) [Срок оценки: At baseline, after 3 months of intervention, and after 6 months of intervention.]
• Changes in Physical Function (SPPB) [Срок оценки: At baseline, after 3 months of intervention, and after 6 months of intervention.]
• Changes in Physical Activity Levels (IPAQ-SF) [Срок оценки: At baseline, after 3 months of intervention, and after 6 months of intervention.]
• Retention Rate [Срок оценки: End of study (after 6 months of intervention).]
• Mid-upper arm circumference (MUAC) [Срок оценки: At baseline, after 3 months of intervention, and after 6 months of intervention.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Малайзия · 1 центр

• Hospital Canselor Tuanku Muhriz UKM — Cheras

Публикации

• Soon QQ, Gilcharan Singh HK, Sahathevan S, Wan Daud WR, Abu Shamsi MY, Mohd R, Abdul Manaf Z. 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. JMIR Res Protoc. 2026 May 12;15:e93558. doi: 10.2196/93558. PMID 42117602

Идентификаторы

NCT: NCT07157397 · GGPM-2024-051

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗