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Not yet recruiting NCT06569732

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

No phase Interventional Protein-Energy Wasting Kidney Failure Hemodialysis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Homemade oral nutrition supplements, Commercial oral nutrition supplements.
Who it may be relevant to
Registry conditions: Protein-Energy Wasting, Kidney Failure, Hemodialysis. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

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

Interventions

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

Primary outcome measures

  • Changes from baseline in Malnutrition Inflammation Score at 3-month and 6-month [Time frame: Baseline, 3-month, and 6-month]
Secondary outcome measures (11)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 34977109
  • Sahathevan 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. PMID 33076282

Identifiers

NCT: NCT06569732 · LPS2409

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗