Effects of Homemade Oral Nutrition Supplements for Patients on Hemodialysis With Protein-energy Wasting

Not Applicable

Not yet recruiting

• Conditions: Protein-Energy Wasting; Kidney Failure; Hemodialysis
• Interventions: Other: Homemade oral nutrition supplements; Other: Commercial oral nutrition supplements

• Registration Number: NCT06569732
• Lead Sponsor: Universiti Malaysia Sabah

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-28
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-23
• Last Update Submitted: 2024-08-23
• Study First Posted: 2024-08-26
• Last Update Posted: 2024-08-26
• Study Start: 2024-11
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Homemade oral nutrition supplements	Homemade oral nutrition supplements	Homemade oral nutrition supplements, 200 ml/day
Commercial oral nutrition supplements	Commercial oral nutrition supplements	Commercial oral nutrition supplements, 200 ml/day

Primary Outcome Measures

Name	Time	Method
Changes from baseline in Malnutrition Inflammation Score at 3-month and 6-month	Baseline, 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.

Secondary Outcome Measures

Name	Time	Method
Changes from baseline in skeletal muscle mass at 3-month and 6-month	Baseline, 3-month, and 6-month	The skeletal muscle mass will be measured using a bio-impedance spectroscopy ro determine muscle mass and fat mass
Changes from baseline in body fat mass at 3-month and 6-month	Baseline, 3-month, and 6-month	The body fat mass will be measured using a bio-impedance spectroscopy ro determine muscle mass and fat mass
Changes from baseline in serum albumin at 3-month and 6-month	Baseline, 3-month, and 6-month	Serum albumin will be obtained from the participants' routine blood test
Changes from baseline in handgrip strength at 3-month and 6-month	Baseline, 3-month, and 6-month	Handgrip strength will be measured using a digital hand dynamometer
Acceptability of oral nutrition supplements	6-month	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.
Changes from baseline in energy intake at 3-month and 6-month	Baseline, 3-month, and 6-month	The energy intake will be assessed using 24-hour diet recall forms
Changes from baseline in intradialytic weight change at 3-month and 6-month	Baseline, 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
Changes from baseline in protein intake at 3-month and 6-month	Baseline, 3-month, and 6-month	The protein intake will be assessed using 24-hour diet recall forms
Changes from baseline in serum potassium at 3-month and 6-month	Baseline, 3-month, and 6-month	Serum potassium will be obtained from the participants' routine blood test
Cost-Effectiveness Ratio	6-month	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).
Changes from baseline in serum phosphorus at 3-month and 6-month	Baseline, 3-month, and 6-month	Serum phosphorus will be obtained from the participants' routine blood test