Effects of Homemade Oral Nutrition Supplements for Patients on Hemodialysis With Protein-energy Wasting (HOMES-HD)

August 23, 2024 updated by: Khor Ban Hock, Universiti Malaysia Sabah

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?

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Homemade oral nutrition supplements
Homemade oral nutrition supplements, 200 ml/day
Other: Homemade oral nutrition supplements
The homemade oral nutrition supplement is made of soy milk, whey protein powder, vegetable oil, and fruit juices
Active Comparator: Commercial oral nutrition supplements
Commercial oral nutrition supplements, 200 ml/day
Other: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 3-month, and 6-month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes from baseline in skeletal muscle mass at 3-month and 6-month
Time Frame: Baseline, 3-month, and 6-month
The skeletal muscle mass will be measured using a bio-impedance spectroscopy ro determine muscle mass and fat mass
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
The body fat mass will be measured using a bio-impedance spectroscopy ro determine muscle mass and fat mass
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
The energy intake will be assessed using 24-hour diet recall forms
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
The protein intake will be assessed using 24-hour diet recall forms
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
The intradialytic weight change will be determined based on difference in post-dialysis and pre-dialysis weight of the next dialysis session
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
Serum albumin will be obtained from the participants' routine blood test
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
Serum phosphorus will be obtained from the participants' routine blood test
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
Serum potassium will be obtained from the participants' routine blood test
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
Handgrip strength will be measured using a digital hand dynamometer
Baseline, 3-month, and 6-month
Cost-Effectiveness Ratio
Time Frame: 6-month
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).
6-month
Acceptability of oral nutrition supplements
Time Frame: 6-month
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.
6-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universiti Malaysia Sabah

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Kidney Foundation Malaysia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ban Hock Khor, PhD, Universiti Malaysia Sabah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 28, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LPS2409

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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