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Completed

NCT Number: NCT04789031

Muscle Status to Oral Nutritional Supplementation in Hemodialysis Patients With Protein Energy Wasting

This multi-centred randomized, open label-controlled trial consists of hemodialysis (HD) patients identified with protein energy wasting (PEW) using the International Society of Renal Nutrition and Metabolism criteria. Intervention provided was oral nutritional supplementation (ONS) for 6 months and changes in muscle status in response toward the treatment was measured using ultrasound imaging method pre- and post-intervention.

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Key information

About this study

This study is a multi-centred randomized, open label-controlled trial where a total of 54 HD patients (29 intervention; 27 control) with PEW were recruited from government, private and non-governmental organization settings. Patients were randomized to either the intervention or control group. The intervention group received ONS (475 kcal and 21.7 g of protein), daily for 6 months. Both intervention and control group received standard nutritional counseling during the study period.

Patients who consented were subjected to a screening for identification of PEW and other eligibility criteria. Patients who fulfilled the inclusion criteria were randomized to either control or intervention group. During the 6 months of treatment period, patients in both control and intervention groups were assessed at baseline, 3rd months and 6th months for changes in muscle status using ultrasound imaging and bio-impedance spectroscopy method, malnutrition inflammation complex syndrome using Malnutrition-Inflammation Score, and other measures indicative of nutritional status including anthropometry, biochemistry, dietary intake and quality of life assessment. These parameters were compared at baseline and 6 months for within and between group differences using general linear model test.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • HD patients receiving standard dialysis treatment (3 sessions per week, 4 hours per session) for >3 months
  • Aged between 18 to 70 years old
  • Diagnosed with PEW using the ISRNM criteria

Exclusion criteria

  • History of poor adherence to HD treatment
  • Prolonged hospitalization or surgery in the past 3 months prior to recruitment
  • Diagnosed with inflammatory diseases or malignancy
  • Vegetarian
  • Regular intake of ONS

Treatment and study plan

Oral nutritional supplementation (ONS)

Dietary Supplement

Patients received a renal specific ONS (Novasource Renal, Nestle) providing 475 kcal and 21.7g of protein per serving on a daily basis for 6 months. This was a ready-to- drink formula available in a tetrabrik pack. Patients consumed the product 30 minutes after commencing their dialysis session or at home after completion of dialysis.

Primary outcomes

  1. Changes in muscle status

    Time frame: Baseline versus 6 months

    Effect of ONS on improving muscle status using ultrasound imaging (quadriceps muscle thickness and cross-sectional area of the rectus femoris muscle) and bio-impedance spectroscopy method (measuring lean tissue mass)

Secondary outcomes

  1. Changes in malnutrition-inflammation complex syndrome

    Time frame: Baseline versus 6 months

    Effect of ONS on improving malnutrition complex syndrome using Malnutrition-Inflammation Score (questionnaire) with lower ratings indicating well-nourished

  2. Changes in anthropometric measures

    Time frame: Baseline versus 6 months

    Effect of ONS on improving post-dialysis weight and body mass index

  3. Changes in nutrition-related biochemistry measures

    Time frame: Baseline versus 6 months

    Effect of ONS on improving serum albumin and serum prealbumin levels

  4. Changes in dietary parameters

    Time frame: Baseline versus 6 months

    Effect of ONS on improving dietary energy and protein intake assessed using 24-hour diet recall forms

  5. Changes in quality of life

    Time frame: Baseline versus 6 months

    Effect of ONS in improving quality of life assessed using the short form-36 questionnaire, with higher total score indicating better quality of life

Sponsors and collaborators

Lead sponsor

Taylor's University

Other

Collaborators

  • National Kidney Foundation, United States

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Mar 9, 2021
Registry last updated
Mar 9, 2021

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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