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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Muscle Wasting, End Stage Renal Disease on Dialysis

Intervention / Treatment
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* Dietary Supplement: Oral nutritional supplementation (ONS)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Patients received oral nutritional supplementation and standard nutritional counseling for 6 months. | Dietary Supplement: Oral nutritional supplementation (ONS)<br>* 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.<br>|
| No Intervention: Control group<br>Patients received standard nutritional counseling for 6 months. | |

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemodialysis, protein energy wasting, oral nutritional supplementation, ultrasound imaging