End Stage Renal Disease (ESRD)NCT07157397
Effect of a Plant-Focused Diet on Nutritional Status in Malnourished Peritoneal Dialysis Patients
A study testing Plant-Focused Diet Counselling and Standard Renal Diet Counselling in people with End Stage Renal Disease (ESRD) and End Stage Kidney Disease (ESRD), run by National University of Malaysia at 1 site in Malaysia.
Trial 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: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease (ESRD), End Stage Kidney Disease (ESRD), Peritoneal Dialysis (PD)
- What is being tested?
- Plant-Focused Diet Counselling and Standard Renal Diet Counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteMalaysia
- Study dates
- 10 Mar 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site, 1 recruiting
- Recruiting
Hospital Canselor Tuanku Muhriz UKM
Cheras, Kuala Lumpur, 56000
Dr. Wan Rohaslizan Binti Wan Daud, +60192218051, rohaslizan@hctm.ukm.edu.my
About this study
Official title: Effect of Plant-Focused Diet on Nutritional Status of Malnourished Patients Undergoing Peritoneal Dialysis in a Selected Hospital Care Setting
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:
Read more
- 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.
Read the detailed 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:
- 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.
- To compare changes in primary outcomes consisting of dietary adequacy, dialysis adequacy, and kidney function, between groups after 3 and 6 months of intervention.
- 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.
- Conditions
- End Stage Renal Disease (ESRD), End Stage Kidney Disease (ESRD), Peritoneal Dialysis (PD), Malnourished
- Being tested
- Plant-Focused Diet Counselling, Standard Renal Diet Counselling
- 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
- Medical subject headings
- Kidney Failure, Chronic, Malnutrition, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant-Focused Diet CounsellingBehavioural
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.
Standard Renal Diet CounsellingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard Renal Diet Counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At baseline, after 3 months of intervention, and after 6 months of intervention.
Secondary outcomes (27)
Changes in Weight
Post-dialysis weight will be measured in kilograms (kg), using a digital scale, with patients wearing light clothing and no heavy objects.
Measured: At baseline, after 3 months of intervention, and after 6 months of intervention.
Height
Height will be measured in centimeters (cm), with patients standing straight on the stadiometer, following the Frankfurt horizontal plane.
Measured: At baseline, after 3 months of intervention, and after 6 months of intervention.
Changes in Body mass index (BMI)
Body mass index will be calculated by dividing weight (kg) by the square of height (m²), recorded as kg/m².
Measured: At baseline, after 3 months of intervention, and after 6 months of intervention.
Changes in Triceps skinfold (TSF)
Triceps skinfold will be assessed using skinfold callipers, recorded in centimetres (cm).
Measured: At baseline, after 3 months of intervention, and after 6 months of intervention.
Changes in Dietary Adherence/Compliance
Patients will be required to complete a 3-day food diary (2 weekdays and 1 weekend). Food diaries will be reviewed monthly, either in person at clinic visits or remotely via phone or messaging, and will be scored using the binary dietary compliance scoring system developed specifically for this study. Using the scoring system (maximum score = 21), a total score of <10.5 out of 21 (<50%) will be classified as poor compliance, while a score of ≥10.5 out of 21 (≥50%) will be considered adequate. Scores range from 0 - 21, with higher scores indicating better compliance.
The scoring system will be pilot tested with patients during the first 2 weeks of the study period.
Measured: Baseline and monthly, for up to 6 months.
Changes in Malnutrition-Inflammation Score (MIS)
Each component (medical history, physical examination, BMI, and laboratory markers) is scored from 0 (normal nutrition status) to 3 (severe nutritional deficit). Total scores range from 0 to 30, with higher scores indicating higher degrees of malnutrition. A score of <5 indicates normal nutritional status, while ≥5 signifies malnutrition.
Measured: At baseline, after 3 months of intervention, and after 6 months of intervention.
Changes in Appetite and Food Satisfaction (AFSQ)
Evaluated using the Appetite and Food Satisfaction Questionnaire (AFSQ). Consists a facial hedonic scale to assess appetite levels and five additional questions. Each question is scored from 0 to 3, with a total score ranging from 0 to 18 and lower scores indicate better appetite and food satisfaction.
Measured: At baseline, after 3 months of intervention, and after 6 months of intervention.
Changes in Quality of life (WHOQOL-BREF)
Evaluated using the World Health Organization Quality of Life-BREF (WHOQOL-BREF). It consists of 26 items categorized into four domains: physical health, psychological well-being, social relationships, and environment. Each item is rated on a 5-point Likert scale, and domain scores are calculated as the mean of their respective items. Raw domain scores are transformed to a 4-20 scale and further converted to a 0-100 scale to facilitate interpretation, with higher scores indicating better QOL
Measured: At baseline, after 3 months of intervention, and after 6 months of intervention.
Changes in Physical Function (SPPB)
Assessed using the Short Physical Performance Battery (SPPB), with scores calculated and higher total scores indicating better physical function. Muscular strength will be measured using the Jamar handgrip dynamometer.
Measured: At baseline, after 3 months of intervention, and after 6 months of intervention.
Changes in Physical Activity Levels (IPAQ-SF)
Evaluated using the International Physical Activity Short Form questionnaire. Total scores are calculated by summing the duration and frequency of all activities, while domain-specific and activity-specific sub scores are also determined. The collected data will be reported as either a continuous measure or in metabolic equivalents (METs) per minute.
Measured: At baseline, after 3 months of intervention, and after 6 months of intervention.
Retention Rate
The retention rate will be calculated as the percentage of participants who complete the 6-month study period. The number of participants completing the study will be divided by the total number enrolled and multiplied by 100.
Measured: End of study (after 6 months of intervention).
Mid-upper arm circumference (MUAC)
Mid-upper arm circumference will be measured using a measuring tape, recorded in centimetres (cm).
Measured: At baseline, after 3 months of intervention, and after 6 months of intervention.
Mid-arm muscle circumference (MAMC)
Mid-arm muscle circumference (MAMC) will be calculated using the formula: MAMC = MUAC - (π × TSF). Measurements will be recorded in centimetres (cm). It serves as an anthropometric indicator of muscle mass and is used as a proxy for lean body mass when bioelectrical impedance analysis (BIA) is unavailable. A lower MAMC reflects reduced muscle reserves and potential malnutrition.
Measured: At baseline, after 3 months of intervention, and after 6 months of intervention.
Changes in Total cholesterol
Serum total cholesterol, a parameter of the lipid profile, will be recorded in mmol/L, obtained from medical records. Results will be compared against standard laboratory reference ranges
Measured: At baseline, after 3 months of intervention, and after 6 months of intervention.
Changes in Triglycerides
Serum tryglycerides, a parameter of the lipid profile, will be recorded in mmol/L, obtained from medical records. Results will be compared against standard laboratory reference ranges
Measured: At baseline, after 3 months of intervention, and after 6 months of intervention.
Changes in High-density lipoprotein cholesterol (HDL-C)
Serum High-density lipoprotein cholesterol (HDL-C), a parameter of the lipid profile, will be recorded in mmol/L, obtained from medical records. Results will be compared against standard laboratory reference ranges
Measured: At baseline, after 3 months of intervention, and after 6 months of intervention.
Changes in Low-density lipoprotein cholesterol (LDL-C)
Serum Low-density lipoprotein cholesterol (LDL-C), a parameter of the lipid profile, will be recorded in mmol/L, obtained from medical records. Results will be compared against standard laboratory reference ranges
Measured: At baseline, after 3 months of intervention, and after 6 months of intervention.
Changes in Glycated haemoglobin (HbA1c)
Glycated haemoglobin (HbA1c), a parameter of the blood glucose profile, will be recorded in %, obtained from medical records. Results will be compared against standard laboratory reference ranges.
Measured: At baseline, after 3 months of intervention, and after 6 months of intervention.
Changes in Fasting Blood Glucose (FBG)
Fasting Blood Glucose (FBG), a parameter of the blood glucose profile, will be recorded in mmol/L, obtained from medical records. Results will be compared against standard laboratory reference ranges.
Measured: At baseline, after 3 months of intervention, and after 6 months of intervention.
Changes in Serum Total Iron Binding Capacity (TIBC)
Serum Total Iron Binding Capacity (TIBC), an inflammatory marker, will be obtained from medical records and recorded in µmol/L. Results will be compared against standard laboratory reference ranges.
Measured: At baseline, after 3 months of intervention, and after 6 months of intervention.
Changes in Serum High-sensitivity C-reactive protein (hsCRP)
Serum hsCRP, an inflammatory marker, will be measured in mg/L. A 10 mL fasting blood sample (following a 12-hour overnight fast) will be collected by trained hospital staff using automated procedures. Samples will be analysed at an external accredited laboratory (Innoquest). Results will be compared against standard laboratory reference ranges.
Measured: At baseline, after 3 months of intervention, and after 6 months of intervention.
Changes in Normalised protein catabolic rate (nPCR)
Normalised protein catabolic rate (nPCR), a protein intake indicator, will be obtained from medical records and recorded in g/kg/day. Results will be compared against standard laboratory reference ranges.
Measured: At baseline, after 3 months of intervention, and after 6 months of intervention.
Dietary Knowledge, Attitude, and Practice (KAP) Questionnaire
Participants will complete a 34-item questionnaire adapted from a validated tool used in haemodialysis patients. It includes three subscales: knowledge (12 items), attitude (7 items), and practice (15 items). Knowledge items are scored 0-1 (correct/incorrect), while attitude and practice items are rated on a 0-4 Likert scale. Total scores range from 0 to 100, with higher total scores indicating better dietary KAP.
Measured: At baseline.
Changes in body fat percentage (%)
Body fat percentage will be measured in percentage (%) using a bioelectrical impedance analysis (BIA) device.
Measured: At baseline, 3 months, and 6 months.
Changes in Fat-free mass (kg)
Fat-free mass will be assessed using a bioelectrical impedance analysis (BIA) device, recorded in kilograms (kg).
Measured: At baseline, 3 months, and 6 months.
Changes in skeletal muscle mass (kg)
Skeletal muscle mass will be measured using a bioelectrical impedance analysis (BIA) device, recorded in kilograms (kg).
Measured: At baseline, 3 months, and 6 months.
Changes in fat mass (kg)
Fat mass will be measured using a bioelectrical impedance analysis (BIA) device, recorded in kilograms (kg).
Measured: At baseline, 3 months, and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start10 Mar 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal Disease (ESRD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harvinder Kaur A/P Gilcharan Singh, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07157397
- Sponsor's protocol ID
- GGPM-2024-051
- Status last verified
- Mar 2026
- First submitted
- 14 Aug 2025
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to confidentiality requirements and to protect participant privacy. Only aggregated, de-identified results will be published.
Publications
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.
PubMed 42117602
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Plant-Focused Diet on Nutritional Status of Malnourished Patients Undergoing Peritoneal Dialysis in a Selected Hospital Care Setting
- ClinicalTrials.gov ID
- NCT07157397
- Acronym / sponsor ID
- GGPM-2024-051
- Conditions
- End Stage Renal Disease (ESRD), End Stage Kidney Disease (ESRD), Peritoneal Dialysis (PD), Malnourished
- Keywords
- Peritoneal Dialysis, End Stage Renal Disease, End Stage Kidney Disease, Malnutrition, Plant-Focused Diet, Plant-Based Diet, Nutritonal Status, Dietary Counselling
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 5 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- 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.
- To compare changes in primary outcomes consisting of dietary adequacy, dialysis adequacy, and kidney function, between groups after 3 and 6 months of intervention.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Plant-Focused Diet | Experimental | Behavioral: Plant-Focused Diet CounsellingParticipants 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. |
| Standard-of-Care Renal Diet | Active comparator | Behavioral: Standard Renal Diet CounsellingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plant-Focused Diet CounsellingIndividualized 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. | Behavioural | Plant-Focused Diet |
| Standard Renal Diet CounsellingIndividualized 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. | Behavioural | Standard-of-Care Renal Diet |
Primary outcome
Changes in Dietary Adequacy
Time frame: 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
Time frame: At baseline, after 3 months of intervention, and after 6 months of intervention.
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.
Changes in Concentration of Urea
Time frame: At baseline, after 3 months of intervention, and after 6 months of intervention.
A renal function parameter, measured in mmol/L, obtained from medical records. Results will be compared against standard laboratory reference ranges.
Changes in Concentration of Creatinine
Time frame: At baseline, after 3 months of intervention, and after 6 months of intervention.
A renal function parameter, measured in µmol/L, obtained from medical records. Results will be compared against standard laboratory reference ranges.
Changes in Concentration of Sodium
Time frame: At baseline, after 3 months of intervention, and after 6 months of intervention.
A renal function parameter, measured in mmol/L, obtained from medical records. Results will be compared against standard laboratory reference ranges.
Changes in Concentration of Potassium
Time frame: At baseline, after 3 months of intervention, and after 6 months of intervention.
A renal function parameter, measured in mmol/L, obtained from medical records. Results will be compared against standard laboratory reference ranges.
Changes in Concentration of Phosphate
Time frame: At baseline, after 3 months of intervention, and after 6 months of intervention.
A renal function parameter, measured in mmol/L, obtained from medical records. Results will be compared against standard laboratory reference ranges.
Changes in Concentration of Serum Albumin
Time frame: At baseline, after 3 months of intervention, and after 6 months of intervention.
A renal function parameter, measured in g/L, obtained from medical records. Results will be compared against standard laboratory reference ranges.
Changes in Concentration of Total Protein
Time frame: At baseline, after 3 months of intervention, and after 6 months of intervention.
A renal function parameter, measured in g/L, obtained from medical records. Results will be compared against standard laboratory reference ranges.
27 secondary outcomes
Changes in Weight
Time frame: At baseline, after 3 months of intervention, and after 6 months of intervention.
Height
Time frame: At baseline, after 3 months of intervention, and after 6 months of intervention.
Changes in Body mass index (BMI)
Time frame: At baseline, after 3 months of intervention, and after 6 months of intervention.
Changes in Triceps skinfold (TSF)
Time frame: At baseline, after 3 months of intervention, and after 6 months of intervention.
Changes in Dietary Adherence/Compliance
Time frame: Baseline and monthly, for up to 6 months.
Changes in Malnutrition-Inflammation Score (MIS)
Time frame: At baseline, after 3 months of intervention, and after 6 months of intervention.
Changes in Appetite and Food Satisfaction (AFSQ)
Time frame: At baseline, after 3 months of intervention, and after 6 months of intervention.
Changes in Quality of life (WHOQOL-BREF)
Time frame: At baseline, after 3 months of intervention, and after 6 months of intervention.
Changes in Physical Function (SPPB)
Time frame: At baseline, after 3 months of intervention, and after 6 months of intervention.
Changes in Physical Activity Levels (IPAQ-SF)
Time frame: At baseline, after 3 months of intervention, and after 6 months of intervention.
Retention Rate
Time frame: End of study (after 6 months of intervention).
Mid-upper arm circumference (MUAC)
Time frame: At baseline, after 3 months of intervention, and after 6 months of intervention.
Mid-arm muscle circumference (MAMC)
Time frame: At baseline, after 3 months of intervention, and after 6 months of intervention.
Changes in Total cholesterol
Time frame: At baseline, after 3 months of intervention, and after 6 months of intervention.
Changes in Triglycerides
Time frame: At baseline, after 3 months of intervention, and after 6 months of intervention.
Changes in High-density lipoprotein cholesterol (HDL-C)
Time frame: At baseline, after 3 months of intervention, and after 6 months of intervention.
Changes in Low-density lipoprotein cholesterol (LDL-C)
Time frame: At baseline, after 3 months of intervention, and after 6 months of intervention.
Changes in Glycated haemoglobin (HbA1c)
Time frame: At baseline, after 3 months of intervention, and after 6 months of intervention.
Changes in Fasting Blood Glucose (FBG)
Time frame: At baseline, after 3 months of intervention, and after 6 months of intervention.
Changes in Serum Total Iron Binding Capacity (TIBC)
Time frame: At baseline, after 3 months of intervention, and after 6 months of intervention.
Changes in Serum High-sensitivity C-reactive protein (hsCRP)
Time frame: At baseline, after 3 months of intervention, and after 6 months of intervention.
Changes in Normalised protein catabolic rate (nPCR)
Time frame: At baseline, after 3 months of intervention, and after 6 months of intervention.
Dietary Knowledge, Attitude, and Practice (KAP) Questionnaire
Time frame: At baseline.
Changes in body fat percentage (%)
Time frame: At baseline, 3 months, and 6 months.
Changes in Fat-free mass (kg)
Time frame: At baseline, 3 months, and 6 months.
Changes in skeletal muscle mass (kg)
Time frame: At baseline, 3 months, and 6 months.
Changes in fat mass (kg)
Time frame: At baseline, 3 months, and 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Derived from this study: PubMed 42117602Soon 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to confidentiality requirements and to protect participant privacy. Only aggregated, de-identified results will be published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plant-Focused Diet Counselling and Standard Renal Diet Counselling in people with End Stage Renal Disease (ESRD) and End Stage Kidney Disease (ESRD), run by National University of Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Harvinder Kaur A/P Gilcharan Singh (+60125902925, harvinder_kaur@ukm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Dietary Adequacy (time frame: At baseline, after 3 months of intervention, and after 6 months of intervention). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07157397, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.