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

National University of Malaysia

Status: Not yet enrolling

Conditions: Peritoneal Dialysis (PD); Malnourished; End Stage Kidney Disease (ESRD); End Stage Renal Disease (ESRD)

Treatments: Behavioral: Standard Renal Diet Counselling; Behavioral: Plant-Focused Diet Counselling

Study type: Interventional

Funder types: Other

Identifiers

NCT07157397

GGPM-2024-051

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Plant-Focused Diet

Experimental group

Description:

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.

Treatment:

Behavioral: Plant-Focused Diet Counselling

Standard-of-Care Renal Diet

Active Comparator group

Description:

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.

Treatment:

Behavioral: Standard Renal Diet Counselling