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

NCT07157397 | Recruiting

• 1 other identifier: GGPM-2024-051
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• 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.

Conditions

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

Keywords

Peritoneal Dialysis; End Stage Renal Disease; End Stage Kidney Disease; Malnutrition; Plant-Focused Diet; Plant-Based Diet; Nutritonal Status; Dietary Counselling; Quality of Life; Physical Fitness; Inflammation; Appetite; Malaysia; Nutritional Intervention

Outcome Measures

Primary Outcomes (9)

• Changes in Dietary Adequacy

  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.

  At baseline, after 3 months of intervention, and after 6 months of intervention

• Changes in Dialysis Adequacy

  Dialysis adequacy will be assessed using weekly Kt/V (urea), obtained from patients' medical records. A total Kt/V \< 1.7 will be considered indicative of inadequate dialysis.

  At baseline, after 3 months of intervention, and after 6 months of intervention.

• Changes in Concentration of Urea

  A renal function parameter, measured in mmol/L, obtained from medical records. Results will be compared against standard laboratory reference ranges.

  At baseline, after 3 months of intervention, and after 6 months of intervention.

• Changes in Concentration of Creatinine

  A renal function parameter, measured in µmol/L, obtained from medical records. Results will be compared against standard laboratory reference ranges.

  At baseline, after 3 months of intervention, and after 6 months of intervention.

• Changes in Concentration of Sodium

  A renal function parameter, measured in mmol/L, obtained from medical records. Results will be compared against standard laboratory reference ranges.

  At baseline, after 3 months of intervention, and after 6 months of intervention.

• Changes in Concentration of Potassium

  A renal function parameter, measured in mmol/L, obtained from medical records. Results will be compared against standard laboratory reference ranges.

  At baseline, after 3 months of intervention, and after 6 months of intervention.

• Changes in Concentration of Phosphate

  A renal function parameter, measured in mmol/L, obtained from medical records. Results will be compared against standard laboratory reference ranges.

  At baseline, after 3 months of intervention, and after 6 months of intervention.

• Changes in Concentration of Serum Albumin

  A renal function parameter, measured in g/L, obtained from medical records. Results will be compared against standard laboratory reference ranges.

  At baseline, after 3 months of intervention, and after 6 months of intervention.

• Changes in Concentration of Total Protein

  A renal function parameter, measured in g/L, obtained from medical records. Results will be compared against standard laboratory reference ranges.

  At baseline, after 3 months of intervention, and after 6 months of intervention.

Secondary Outcomes (27)

• Changes in Weight

  At baseline, after 3 months of intervention, and after 6 months of intervention.

• Height

  At baseline, after 3 months of intervention, and after 6 months of intervention.

• Changes in Body mass index (BMI)

  At baseline, after 3 months of intervention, and after 6 months of intervention.

• Changes in Triceps skinfold (TSF)

  At baseline, after 3 months of intervention, and after 6 months of intervention.

• Changes in Dietary Adherence/Compliance

  Baseline and monthly, for up to 6 months.

Study Arms (2)

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.

Behavioral: Plant-Focused Diet Counselling

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.

Behavioral: Standard Renal Diet Counselling

Interventions

Plant-Focused Diet Counselling BEHAVIORAL

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.

Plant-Focused Diet

Standard Renal Diet Counselling BEHAVIORAL

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.

Standard-of-Care Renal Diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Malaysia: lead

Study Sites (1)

Hospital Canselor Tuanku Muhriz UKM

Cheras, Kuala Lumpur, 56000, Malaysia

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic; Malnutrition; Inflammation

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Central Study Contacts

Dr. Harvinder Kaur A/P Gilcharan Singh

CONTACT

+60125902925; harvinder_kaur@ukm.edu.my

Qiao Qian Soon

CONTACT

+60126553396; s.qiaoqian@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants are randomly allocated to one of two groups: a plant-focused diet group or a standard-of-care renal diet group. Each participant will remain in their assigned group for the entire 6-month intervention period.

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: September 5, 2025
• Study Start: March 10, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)