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

NCT06569732 | Not Yet Recruiting

• 1 other identifier: LPS2409
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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

Conditions

Protein-Energy Wasting; Kidney Failure; Hemodialysis

Keywords

hemodialysis; protein-energy wasting; kidney failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Changes from baseline in skeletal muscle mass at 3-month and 6-month

  Baseline, 3-month, and 6-month

• Changes from baseline in body fat mass at 3-month and 6-month

  Baseline, 3-month, and 6-month

• Changes from baseline in energy intake at 3-month and 6-month

  Baseline, 3-month, and 6-month

• Changes from baseline in protein intake at 3-month and 6-month

  Baseline, 3-month, and 6-month

• Changes from baseline in intradialytic weight change at 3-month and 6-month

  Baseline, 3-month, and 6-month

Study Arms (2)

Homemade oral nutrition supplements

EXPERIMENTAL

Homemade oral nutrition supplements, 200 ml/day

Other: Homemade oral nutrition supplements

Commercial oral nutrition supplements

ACTIVE COMPARATOR

Commercial oral nutrition supplements, 200 ml/day

Other: Commercial oral nutrition supplements

Interventions

Homemade oral nutrition supplements OTHER

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

Homemade oral nutrition supplements

Commercial oral nutrition supplements 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

Commercial oral nutrition supplements

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Malaysia Sabah: lead
• National Kidney Foundation Malaysia: collaborator

Related Publications (2)

• 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.

  PMID: 34977109 BACKGROUND

• 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.

  PMID: 33076282 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Ban Hock Khor, PhD

  Universiti Malaysia Sabah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ban Hock Khor, PhD

CONTACT

+6088320000; khorbanhock@ums.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Study Record Dates

• First Submitted: July 28, 2024
• First Posted: August 26, 2024
• Study Start: November 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share