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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-01

Study Completion Date

2019-07-31

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.

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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.

Conditions

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Muscle Wasting End Stage Renal Disease on Dialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention group

Patients received oral nutritional supplementation and standard nutritional counseling for 6 months.

Group Type EXPERIMENTAL

Oral nutritional supplementation (ONS)

Intervention Type 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.

Control group

Patients received standard nutritional counseling for 6 months.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No