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

N/ANot Yet RecruitingNCT06569732

Universiti Malaysia Sabah40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Protein-Energy Wasting Kidney Failure Hemodialysis

Homemade oral nutrition supplementsOTHER

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

Commercial oral nutrition supplementsOTHER

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

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.