Effects of Homemade Oral Nutrition Supplements for Patients on Hemodialysis With Protein-energy Wasting (HOMES-HD)

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Hemodialysis; Kidney Failure; Protein-Energy Wasting
• Intervention / Treatment: Other: Homemade oral nutrition supplements; Other: Commercial oral nutrition supplements

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ban Hock Khor, PhD; Phone Number: 104475 +6088320000; Email: khorbanhock@ums.edu.my

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Homemade oral nutrition supplements; Homemade oral nutrition supplements, 200 ml/day	Other: Homemade oral nutrition supplements; The homemade oral nutrition supplement is made of soy milk, whey protein powder, vegetable oil, and fruit juices
Active Comparator: Commercial oral nutrition supplements; Commercial oral nutrition supplements, 200 ml/day	Other: Commercial oral nutrition supplements; The commercial oral nutrition supplement is kidney-specific oral nutrition supplement that is high in energy and protein, but low in electrolytes and fluid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Universiti Malaysia Sabah
• Collaborators: National Kidney Foundation Malaysia
• Investigators: Principal Investigator: Ban Hock Khor, PhD, Universiti Malaysia Sabah

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: July 28, 2024
• First Submitted That Met QC Criteria: August 23, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): August 26, 2024
• Last Update Submitted That Met QC Criteria: August 23, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: hemodialysis; kidney failure; protein-energy wasting
• Additional Relevant MeSH Terms: Metabolic Diseases; Kidney Diseases; Urologic Diseases; Nutrition Disorders; Body Weight; Body Weight Changes; Weight Loss; Thinness; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency; Wasting Syndrome; Cachexia
• Other Study ID Numbers: LPS2409

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No