Plant-focused diet to improve nutrition in malnourished adults on peritoneal dialysis.
Effect of Plant-Focused Diet on Nutritional Status of Malnourished Patients Undergoing Peritoneal Dialysis in a Selected Hospital Care Setting
This trial will test whether a plant-focused diet helps malnourished adults on peritoneal dialysis improve their nutrition and health over six months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National University of Malaysia Academic / other |
| Locations | 1 site (Cheras, Kuala Lumpur) |
| Trial ID | NCT07157397 on ClinicalTrials.gov |
What this trial studies
This is a randomized, open-label trial comparing a plant-focused diet to a standard renal diet in malnourished adults receiving peritoneal dialysis. Participants will be randomized to receive individualized dietary counselling for their assigned diet and will be followed for six months with visits at baseline, 1, 3, and 6 months plus monthly virtual check-ins. Key outcomes include anthropometric measurements, biochemical markers (including serum albumin and kidney function), dietary intake, and malnutrition-inflammation scores measured at baseline, 3 months, and 6 months. Safety and feasibility of the plant-focused diet in this population will be monitored throughout the study.
Who should consider this trial
Good fit: Ideal candidates are adults (>18) on peritoneal dialysis for at least six months who are malnourished (serum albumin <40 g/L, BMI <25 kg/m2, and an elevated malnutrition-inflammation score) and willing to follow dietary counselling and scheduled follow-ups.
Not a fit: Patients with recent hospitalization, active infection or sepsis, recent surgery, active malignancy, or inadequate dialysis (Kt/V <1.2) are excluded and may not derive benefit from this intervention.
Why it matters
Potential benefit: If successful, a plant-focused diet could improve nutritional status, reduce inflammation, and lower complications for malnourished peritoneal dialysis patients.
How similar studies have performed: Emerging studies suggest plant-focused diets can improve inflammation and metabolic markers, but robust evidence in malnourished peritoneal dialysis patients is limited and this application is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Cheras, Kuala Lumpur
- Hospital Canselor Tuanku Muhriz UKM — Cheras, Kuala Lumpur, Malaysia (Recruiting)
Study contacts
- Study coordinator: Dr. Harvinder Kaur A/P Gilcharan Singh
- Email: harvinder_kaur@ukm.edu.my
- Phone: +60125902925
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.