Clinical trial NCT06569732: Effects of Homemade Oral Nutrition Supplements for Patients on Hemodialysis With Protein-energy Wasting
Official title: Clinical Efficacy, Feasibility, and Cost-effectiveness of Homemade Oral Nutrition Supplements on Patients on Hemodialysis With Protein-energy Wasting: a Parallel, Open-labeled, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Protein-Energy Wasting
Kidney Failure
Hemodialysis
Keywords: hemodialysis
protein-energy wasting
kidney failure
Lead sponsor: Universiti Malaysia Sabah
Sponsor class: OTHER
Collaborators: name: National Kidney Foundation Malaysia
First posted: 2024-08-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: Inclusion Criteria:

* on maintenance HD dialysis treatment (thrice weekly and 4-hour per session) for at least three months
* age 18 - 70 year old
* diagnosed with protein energy wasting using the malnutrition inflammation score (≥ 5)

Exclusion Criteria:

* a history of poor adherence to HD treatment (frequently miss the HD treatment for more than one session every month)
* a history of frequent hospitalization (more than once in the past one month)
* on regular oral nutrition supplements
* diagnosed with malignancy
* pregnant or lactating women
* allergic to study products such as soy milk or milk

Primary outcomes:
measure: Changes from baseline in Malnutrition Inflammation Score at 3-month and 6-month
timeFrame: Baseline, 3-month, and 6-month
Secondary outcomes:
measure: Changes from baseline in skeletal muscle mass at 3-month and 6-month
timeFrame: Baseline, 3-month, and 6-month
measure: Changes from baseline in body fat mass at 3-month and 6-month
timeFrame: Baseline, 3-month, and 6-month
measure: Changes from baseline in energy intake at 3-month and 6-month
timeFrame: Baseline, 3-month, and 6-month
measure: Changes from baseline in protein intake at 3-month and 6-month
timeFrame: Baseline, 3-month, and 6-month
measure: Changes from baseline in intradialytic weight change at 3-month and 6-month
timeFrame: Baseline, 3-month, and 6-month
measure: Changes from baseline in serum albumin at 3-month and 6-month
timeFrame: Baseline, 3-month, and 6-month
measure: Changes from baseline in serum phosphorus at 3-month and 6-month
timeFrame: Baseline, 3-month, and 6-month
measure: Changes from baseline in serum potassium at 3-month and 6-month
timeFrame: Baseline, 3-month, and 6-month
measure: Changes from baseline in handgrip strength at 3-month and 6-month
timeFrame: Baseline, 3-month, and 6-month
measure: Cost-Effectiveness Ratio
timeFrame: 6-month
measure: Acceptability of oral nutrition supplements
timeFrame: 6-month
Other outcomes:
Locations:
Study officials:
affiliation: Universiti Malaysia Sabah
name: Ban Hock Khor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sahathevan S, Karupaiah T, Khor BH, Sadu Singh BK, Mat Daud ZA, Fiaccadori E, Sabatino A, Chinna K, Abdul Gafor AH, Bavanandan S, Visvanathan R, Yahya R, Wahab Z, Goh BL, Morad Z, Bee BC, Wong HS. Muscle Status Response to Oral Nutritional Supplementation in Hemodialysis Patients With Protein Energy Wasting: A Multi-Center Randomized, Open Label-Controlled Trial. Front Nutr. 2021 Dec 10;8:743324. doi: 10.3389/fnut.2021.743324. eCollection 2021.
citation: Sahathevan S, Khor BH, Ng HM, Gafor AHA, Mat Daud ZA, Mafra D, Karupaiah T. Understanding Development of Malnutrition in Hemodialysis Patients: A Narrative Review. Nutrients. 2020 Oct 15;12(10):3147. doi: 10.3390/nu12103147.