Protein-Energy WastingHOMES-HDNCT06569732
Effects of Homemade Oral Nutrition Supplements for Patients on Hemodialysis With Protein-energy Wasting
A study testing Homemade oral nutrition supplements and Commercial oral nutrition supplements in people with Protein-Energy Wasting and Kidney Failure, run by Universiti Malaysia Sabah.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Protein-Energy Wasting, Kidney Failure, Hemodialysis
- What is being tested?
- Homemade oral nutrition supplements and Commercial oral nutrition supplements
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Nov 2024to Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Efficacy, Feasibility, and Cost-effectiveness of Homemade Oral Nutrition Supplements on Patients on Hemodialysis With Protein-energy Wasting: a Parallel, Open-labeled, Randomized Controlled 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?
Read more
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
- Being tested
- Homemade oral nutrition supplements, Commercial oral nutrition supplements
- Keywords
- hemodialysis, protein-energy wasting, kidney failure
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Homemade oral nutrition supplements | Experimental | Homemade oral nutrition supplements, 200 ml/day Receives: Other: Homemade oral nutrition supplements |
| Commercial oral nutrition supplements | Active comparator | Commercial oral nutrition supplements, 200 ml/day Receives: Other: Commercial oral nutrition supplements |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3-month, and 6-month
Secondary outcomes (11)
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
Measured: Baseline, 3-month, and 6-month
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
Measured: Baseline, 3-month, and 6-month
Changes from baseline in energy intake at 3-month and 6-month
The energy intake will be assessed using 24-hour diet recall forms
Measured: Baseline, 3-month, and 6-month
Changes from baseline in protein intake at 3-month and 6-month
The protein intake will be assessed using 24-hour diet recall forms
Measured: Baseline, 3-month, and 6-month
Changes from baseline in intradialytic weight change at 3-month and 6-month
The intradialytic weight change will be determined based on difference in post-dialysis and pre-dialysis weight of the next dialysis session
Measured: Baseline, 3-month, and 6-month
Changes from baseline in serum albumin at 3-month and 6-month
Serum albumin will be obtained from the participants' routine blood test
Measured: Baseline, 3-month, and 6-month
Changes from baseline in serum phosphorus at 3-month and 6-month
Serum phosphorus will be obtained from the participants' routine blood test
Measured: Baseline, 3-month, and 6-month
Changes from baseline in serum potassium at 3-month and 6-month
Serum potassium will be obtained from the participants' routine blood test
Measured: Baseline, 3-month, and 6-month
Changes from baseline in handgrip strength at 3-month and 6-month
Handgrip strength will be measured using a digital hand dynamometer
Measured: Baseline, 3-month, and 6-month
Cost-Effectiveness Ratio
The cost-effectiveness ratio will be calculated by dividing the cost of oral nutrition supplements (unit in Malaysia ringgit) for 6 months with the change in malnutrition inflammation score from baseline to 6-month (refer primary outcome 1). In this analysis, there is no minimum or maximum values, but a lower value indicates better cost-effectiveness (lower cost with a greater health benefit).
Measured: 6-month
Acceptability of oral nutrition supplements
A questionnaire will be used to assess product acceptance using a 5-point Likert scale. The scale ranges from 1 to 5, with higher scores indicating greater acceptance of the product. The questionnaire consists of 5 questions, so the total score ranges from a minimum of 5 to a maximum of 25.
Measured: 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study startNov 2024 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Protein-Energy WastingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Malaysia Sabah
- Sponsor type
- University, hospital or other
- Collaborators
- National Kidney Foundation Malaysia
- Responsible party
- Principal investigator, Khor Ban Hock, Universiti Malaysia Sabah
- Investigators
- Ban Hock Khor, PhD, Principal investigator, Universiti Malaysia Sabah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06569732
- Sponsor's protocol ID
- LPS2409
- Acronym
- HOMES-HD
- Status last verified
- Aug 2024
- First submitted
- 28 Jul 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34977109Sahathevan 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.
PubMed 33076282
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy, Feasibility, and Cost-effectiveness of Homemade Oral Nutrition Supplements on Patients on Hemodialysis With Protein-energy Wasting: a Parallel, Open-labeled, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06569732
- Acronym / sponsor ID
- HOMES-HD / LPS2409
- Conditions
- Protein-Energy Wasting, Kidney Failure, Hemodialysis
- Keywords
- hemodialysis, protein-energy wasting, kidney failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universiti Malaysia SabahUniversity, hospital or other
- Collaborators
- National Kidney Foundation Malaysia
- Study start
- Nov 2024 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Homemade oral nutrition supplements | Experimental | Other: Homemade oral nutrition supplementsHomemade oral nutrition supplements, 200 ml/day |
| Commercial oral nutrition supplements | Active comparator | Other: Commercial oral nutrition supplementsCommercial oral nutrition supplements, 200 ml/day |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Homemade oral nutrition supplementsThe homemade oral nutrition supplement is made of soy milk, whey protein powder, vegetable oil, and fruit juices | Other | Homemade oral nutrition supplements |
| Commercial oral nutrition supplementsThe commercial oral nutrition supplement is kidney-specific oral nutrition supplement that is high in energy and protein, but low in electrolytes and fluid | Other | Commercial oral nutrition supplements |
Primary outcome
Changes from baseline in Malnutrition Inflammation Score at 3-month and 6-month
Time frame: Baseline, 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.
11 secondary outcomes
Changes from baseline in skeletal muscle mass at 3-month and 6-month
Time frame: Baseline, 3-month, and 6-month
Changes from baseline in body fat mass at 3-month and 6-month
Time frame: Baseline, 3-month, and 6-month
Changes from baseline in energy intake at 3-month and 6-month
Time frame: Baseline, 3-month, and 6-month
Changes from baseline in protein intake at 3-month and 6-month
Time frame: Baseline, 3-month, and 6-month
Changes from baseline in intradialytic weight change at 3-month and 6-month
Time frame: Baseline, 3-month, and 6-month
Changes from baseline in serum albumin at 3-month and 6-month
Time frame: Baseline, 3-month, and 6-month
Changes from baseline in serum phosphorus at 3-month and 6-month
Time frame: Baseline, 3-month, and 6-month
Changes from baseline in serum potassium at 3-month and 6-month
Time frame: Baseline, 3-month, and 6-month
Changes from baseline in handgrip strength at 3-month and 6-month
Time frame: Baseline, 3-month, and 6-month
Cost-Effectiveness Ratio
Time frame: 6-month
Acceptability of oral nutrition supplements
Time frame: 6-month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Background: PubMed 34977109Sahathevan 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.
- Background: PubMed 33076282Sahathevan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ban Hock Khor, PhD principal investigator
Universiti Malaysia Sabah
Questions about this trial
What is this clinical trial studying?
A study testing Homemade oral nutrition supplements and Commercial oral nutrition supplements in people with Protein-Energy Wasting and Kidney Failure, run by Universiti Malaysia Sabah.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ban Hock Khor, PhD (+6088320000 ext. 104475, khorbanhock@ums.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in Malnutrition Inflammation Score at 3-month and 6-month (time frame: Baseline, 3-month, and 6-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06569732, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.