[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605044":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":54,"collaborators":26,"id":58,"slug":26,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":26,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":26,"enrollmentInfo":66,"targetDuration":26,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":78,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"National University of Malaysia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Behavioral: Plant-Focused Diet Counselling",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",[19],"Behavioral: Standard Renal Diet Counselling",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","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.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"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.",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Dr. Harvinder Kaur A\u002FP Gilcharan Singh","CONTACT","+60125902925","harvinder_kaur@ukm.edu.my",{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},"Qiao Qian Soon","+60126553396","s.qiaoqian@gmail.com",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"cosmosGeoPoint":26,"geoPoint":26,"contacts":49},"Hospital Canselor Tuanku Muhriz UKM","RECRUITING","Cheras","Kuala Lumpur","56000","Malaysia",[50],{"name":51,"role":34,"phone":52,"phoneExt":26,"email":53},"Dr. Wan Rohaslizan Binti Wan Daud","+60192218051","rohaslizan@hctm.ukm.edu.my",{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Harvinder Kaur A\u002FP Gilcharan Singh","Principal Investigator","100605044",false,"NCT07157397","Effect of a Plant-Focused Diet on Nutritional Status in Malnourished Peritoneal Dialysis Patients","Effect of Plant-Focused Diet on Nutritional Status of Malnourished Patients Undergoing Peritoneal Dialysis in a Selected Hospital Care Setting","Inclusion Criteria:\n\n* Adult outpatients (\\>18 years old), attending HTCM PD clinic visits\n* Have undergone peritoneal dialysis for at least 6 months\n* Have a serum albumin level \\\u003C40 g\u002FL\n* Have a BMI of \\\u003C 25 kg\u002Fm2\n* Have a malnutrition inflammation score (MIS) of mild, moderate or severe\n* Agreed to follow the dietary instructions based on the randomization assignment\n* 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\n\nExclusion Criteria:\n\n* Have been hospitalized for the past 3 months\n* Have ongoing infection\u002Fsepsis\n* Has undergone surgery in the past 6 months\n* Have high inflammatory diseases, malignancy, or cancer\n* Have dialysis adequacy of \\\u003C1.2 Kt\u002FV","ALL","18 Years",{"count":67,"type":68},100,"ESTIMATED","INTERVENTIONAL",[71],"NA","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.\n\nThe main questions it aims to answer are:\n\n1. Does a plant-focused diet improve nutritional status compared to a standard kidney diet in PD patients?\n2. What changes occur in anthropometric, biochemical, and dietary measures over 6 months?\n\nResearchers 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.\n\nParticipants will:\n\n* Be randomly assigned to follow the plant-focused diet or the standard diet.\n* Be monitored for 6 months through in-person visits (aligned with their routine clinic appointments) and virtual check-ins via messages or calls.\n* Have their progress monitored for changes in outcomes such as nutrition, blood tests, kidney function, and quality of life.",[74,75,76,77],"End Stage Renal Disease (ESRD)","End Stage Kidney Disease (ESRD)","Peritoneal Dialysis (PD)","Malnourished",[79,80,81,82,9,83,84,85,86,87,88,89,48,90],"Peritoneal Dialysis","End Stage Renal Disease","End Stage Kidney Disease","Malnutrition","Plant-Based Diet","Nutritonal Status","Dietary Counselling","Quality of Life","Physical Fitness","Inflammation","Appetite","Nutritional Intervention","2026-03-12",{"date":93,"type":94},"2026-03-16","ACTUAL",{"date":96,"type":94},"2026-03-10",{"date":98,"type":68},"2027-03-31",{"name":5,"class":6},1]