Effects of Homemade Oral Nutrition Supplements for Patients on Hemodialysis With Protein-energy Wasting
NCT Number: NCT06569732
Acronym: HOMES-HD
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Protein-Energy Wasting|Kidney Failure|Hemodialysis
Interventions: OTHER: Homemade oral nutrition supplements|OTHER: Commercial oral nutrition supplements
Sponsor: Universiti Malaysia Sabah
Collaborators: National Kidney Foundation Malaysia
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-11
Completion Date: 2025-11

Summary:
The goal of this clinical trial is to learn if homemade oral nutrition supplements works to treat protein energy wasting in patients on hemodialysis. It will also learn about the cost-effectiveness of homemade oral nutrition supplements. The main questions it aims to answer are:

* Does homemade oral nutrition supplements improve the nutritional status of patients on hemodialysis with protein energy wasting?
* What is the cost-effectiveness of homemade oral nutrition supplements?

Researchers will compare homemade oral nutrition supplements to commercial oral nutrition supplements to see if homemade oral nutrition supplements works to treat protein energy wasting in patients on hemodialysis.

Participants will:

* Take homemade or commercial oral nutrition supplements every day for 6 months
* Have assessment of nutritional status performed by researchers every three monthly

Primary Outcome Measures: Changes from baseline in Malnutrition Inflammation Score at 3-month and 6-month, The Malnutrition Inflammation Score is a composite score used to determine protein energy wasting. It consists of 10 questions, each rated on a scale from 0 to 3. The total score ranges from 0 to 30, with higher scores indicating more severe malnutrition and inflammation. A score of 5 or above suggests the presence of protein-energy wasting., Baseline, 3-month, and 6-month
Secondary Outcome Measures: Changes from baseline in skeletal muscle mass at 3-month and 6-month, The skeletal muscle mass will be measured using a bio-impedance spectroscopy ro determine muscle mass and fat mass, Baseline, 3-month, and 6-month|Changes from baseline in body fat mass at 3-month and 6-month, The body fat mass will be measured using a bio-impedance spectroscopy ro determine muscle mass and fat mass, Baseline, 3-month, and 6-month|Changes from baseline in energy intake at 3-month and 6-month, The energy intake will be assessed using 24-hour diet recall forms, Baseline, 3-month, and 6-month|Changes from baseline in protein intake at 3-month and 6-month, The protein intake will be assessed using 24-hour diet recall forms, Baseline, 3-month, and 6-month|Changes from baseline in intradialytic weight change at 3-month and 6-month, The intradialytic weight change will be determined based on difference in post-dialysis and pre-dialysis weight of the next dialysis session, Baseline, 3-month, and 6-month|Changes from baseline in serum albumin at 3-month and 6-month, Serum albumin will be obtained from the participants' routine blood test, Baseline, 3-month, and 6-month|Changes from baseline in serum phosphorus at 3-month and 6-month, Serum phosphorus will be obtained from the participants' routine blood test, Baseline, 3-month, and 6-month|Changes from baseline in serum potassium at 3-month and 6-month, Serum potassium will be obtained from the participants' routine blood test, Baseline, 3-month, and 6-month|Changes from baseline in handgrip strength at 3-month and 6-month, Handgrip strength will be measured using a digital hand dynamometer, Baseline, 3-month, and 6-month|Cost-Effectiveness Ratio, The cost-effectiveness ratio will be calculated by dividing the cost of oral nutrition supplements (unit in Malaysia ringgit) for 6 months with the change in malnutrition inflammation score from baseline to 6-month (refer primary outcome 1). In this analysis, there is no minimum or maximum values, but a lower value indicates better cost-effectiveness (lower cost with a greater health benefit)., 6-month|Acceptability of oral nutrition supplements, A questionnaire will be used to assess product acceptance using a 5-point Likert scale. The scale ranges from 1 to 5, with higher scores indicating greater acceptance of the product. The questionnaire consists of 5 questions, so the total score ranges from a minimum of 5 to a maximum of 25., 6-month