Effects of Homemade Oral Nutrition Supplements for Patients on Hemodialysis With Protein-energy Wasting
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversiti Malaysia Sabah
About this 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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Homemade oral nutrition supplements
Other interventionThe homemade oral nutrition supplement is made of soy milk, whey protein powder, vegetable oil, and fruit juices
Commercial oral nutrition supplements
Other interventionThe commercial oral nutrition supplement is kidney-specific oral nutrition supplement that is high in energy and protein, but low in electrolytes and fluid
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Homemade oral nutrition supplementsExperimental treatment 1 intervention
Group B: Commercial oral nutrition supplementsActive comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline, 3-month, and 6-monthSecondary outcomes
1
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
Time frame
Baseline, 3-month, and 6-month2
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
Time frame
Baseline, 3-month, and 6-month3
Changes from baseline in energy intake at 3-month and 6-month
The energy intake will be assessed using 24-hour diet recall forms
Time frame
Baseline, 3-month, and 6-month4
Changes from baseline in protein intake at 3-month and 6-month
The protein intake will be assessed using 24-hour diet recall forms
Time frame
Baseline, 3-month, and 6-monthLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Universiti Malaysia Sabah
Lead sponsor
National Kidney Foundation Malaysia
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: