Effects of Homemade Oral Nutrition Supplements for Patients on Hemodialysis With Protein-energy Wasting
NCT ID: NCT06569732
Last Updated: 2024-08-26
Study Results
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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NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2024-11-30
2025-11-30
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Homemade oral nutrition supplements
Homemade oral nutrition supplements, 200 ml/day
Homemade oral nutrition supplements
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
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
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
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
Eligibility Criteria
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Inclusion Criteria
* age 18 - 70 year old
* diagnosed with protein energy wasting using the malnutrition inflammation score (≥ 5)
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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National Kidney Foundation Malaysia
UNKNOWN
Universiti Malaysia Sabah
OTHER
Responsible Party
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Khor Ban Hock
Senior Lecturer
Principal Investigators
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Ban Hock Khor, PhD
Role: PRINCIPAL_INVESTIGATOR
Universiti Malaysia Sabah
Central Contacts
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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.
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.
Other Identifiers
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LPS2409
Identifier Type: -
Identifier Source: org_study_id
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