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NCT Number: NCT06569732

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

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

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Key information

Conditions

Protein-Energy Wasting Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemodialysis Kidney Diseases Kidney Failure Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Homemade oral nutrition supplements

Other

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

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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).

  11. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ban Hock Khor, PhD

CONTACT

[email protected]

+6088320000 ext. 104475

Sponsors and collaborators

Lead sponsor

Universiti Malaysia Sabah

Other

Collaborators

  • National Kidney Foundation Malaysia

Registry information

Official study 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

Acronym: HOMES-HD

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 26, 2024
Registry last updated
Aug 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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