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

NCT ID: NCT06569732

Last Updated: 2024-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-30

Study Completion Date

2025-11-30

Brief Summary

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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

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Conditions

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Protein-Energy Wasting Kidney Failure Hemodialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Homemade oral nutrition supplements

Homemade oral nutrition supplements, 200 ml/day

Group Type EXPERIMENTAL

Homemade oral nutrition supplements

Intervention Type OTHER

The homemade oral nutrition supplement is made of soy milk, whey protein powder, vegetable oil, and fruit juices

Commercial oral nutrition supplements

Commercial oral nutrition supplements, 200 ml/day

Group Type ACTIVE_COMPARATOR

Commercial oral nutrition supplements

Intervention Type OTHER

The commercial oral nutrition supplement is kidney-specific oral nutrition supplement that is high in energy and protein, but low in electrolytes and fluid

Interventions

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Homemade oral nutrition supplements

The homemade oral nutrition supplement is made of soy milk, whey protein powder, vegetable oil, and fruit juices

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Kidney Foundation Malaysia

UNKNOWN

Sponsor Role collaborator

Universiti Malaysia Sabah

OTHER

Sponsor Role lead

Responsible Party

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Khor Ban Hock

Senior Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ban Hock Khor, PhD

Role: PRINCIPAL_INVESTIGATOR

Universiti Malaysia Sabah

Central Contacts

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Ban Hock Khor, PhD

Role: CONTACT

+6088320000 ext. 104475

References

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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.

Reference Type BACKGROUND
PMID: 34977109 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33076282 (View on PubMed)

Other Identifiers

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LPS2409

Identifier Type: -

Identifier Source: org_study_id

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