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

Sponsor

Taylor's University (Other)

Overall Status

Completed

CT.gov ID

NCT04789031

Collaborator

National Kidney Foundation (Other)

Enrollment

Arms

37.9

Actual Duration (Months)

Study Details

Study Description

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)	N/A

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

Study Type:

Interventional

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.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 :

Jun 1, 2016

Actual Primary Completion Date :

Jul 31, 2019

Actual Study Completion Date :

Jul 31, 2019

Arms and Interventions

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.

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

Primary Outcome Measures

Changes in muscle status [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

Changes in malnutrition-inflammation complex syndrome [Baseline versus 6 months]
Effect of ONS on improving malnutrition complex syndrome using Malnutrition-Inflammation Score (questionnaire) with lower ratings indicating well-nourished
Changes in anthropometric measures [Baseline versus 6 months]
Effect of ONS on improving post-dialysis weight and body mass index
Changes in nutrition-related biochemistry measures [Baseline versus 6 months]
Effect of ONS on improving serum albumin and serum prealbumin levels
Changes in dietary parameters [Baseline versus 6 months]
Effect of ONS on improving dietary energy and protein intake assessed using 24-hour diet recall forms
Changes in quality of life [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

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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