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

March 4, 2021 updated by: Tilakavati Karupaiah, Taylor's University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

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

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline versus 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline versus 6 months
Changes in anthropometric measures
Time Frame: Baseline versus 6 months
Effect of ONS on improving post-dialysis weight and body mass index
Baseline versus 6 months
Changes in nutrition-related biochemistry measures
Time Frame: Baseline versus 6 months
Effect of ONS on improving serum albumin and serum prealbumin levels
Baseline versus 6 months
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
Baseline versus 6 months
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
Baseline versus 6 months

Collaborators and Investigators

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

Sponsor

Taylor's University

Collaborators

National Kidney Foundation

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 (ACTUAL)

June 1, 2016

Primary Completion (ACTUAL)

July 31, 2019

Study Completion (ACTUAL)

July 31, 2019

Study Registration Dates

First Submitted

March 1, 2021

First Submitted That Met QC Criteria

March 4, 2021

First Posted (ACTUAL)

March 9, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 9, 2021

Last Update Submitted That Met QC Criteria

March 4, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NKF/2018/SBS/01
  • NMRR-16-2525-32068 (REGISTRY: National Medical Research Register)

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.

Clinical Trials on End Stage Renal Disease on Dialysis

Clinical Trials on Oral nutritional supplementation (ONS)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe