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

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ClinicalTrials.gov Identifier: NCT04789031
Recruitment Status : Completed
First Posted : March 9, 2021
Last Update Posted : March 9, 2021
Sponsor:
Collaborator:
National Kidney Foundation
Information provided by (Responsible Party):
Tilakavati Karupaiah, Taylor's University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Muscle Wasting End Stage Renal Disease on Dialysis Dietary Supplement: Oral nutritional supplementation (ONS) Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients were allocated to intervention and control group. The intervention group received commercial renal-specific ONS for six months. Both groups received standard nutritional counseling during the study period.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Muscle Status to Oral Nutritional Supplementation in Hemodialysis Patients With Protein Energy Wasting
Actual Study Start Date : June 1, 2016
Actual Primary Completion Date : July 31, 2019
Actual Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention group
Patients received oral nutritional supplementation and standard nutritional counseling for 6 months.
 Dietary Supplement: Oral nutritional supplementation (ONS)
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.
No Intervention: Control group
Patients received standard nutritional counseling for 6 months.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04789031


Sponsors and Collaborators
Taylor's University
National Kidney Foundation
Investigators
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Principal Investigator: Tilakavati Karupaiah, PhD Taylor's University
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Tilakavati Karupaiah, Prof Dr Tilakavati Karupaiah, Taylor's University
ClinicalTrials.gov Identifier: NCT04789031    
Other Study ID Numbers: NKF/2018/SBS/01
NMRR-16-2525-32068 ( Registry Identifier: National Medical Research Register )
First Posted: March 9, 2021    Key Record Dates
Last Update Posted: March 9, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tilakavati Karupaiah, Taylor's University:
hemodialysis
protein energy wasting
oral nutritional supplementation
ultrasound imaging
Additional relevant MeSH terms:
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Muscular Atrophy
Kidney Failure, Chronic
Wasting Syndrome
Cachexia
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Emaciation
Weight Loss
 Body Weight Changes
Body Weight
Metabolic Diseases
Nutrition Disorders
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical