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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04789031
Enrollment
54
Registered
2021-03-09
Start date
2016-06-01
Completion date
2019-07-31
Last updated
2021-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease on Dialysis, Muscle Wasting

Keywords

hemodialysis, protein energy wasting, oral nutritional supplementation, ultrasound imaging

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.

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.

Interventions

DIETARY_SUPPLEMENTOral 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.

Sponsors

National Kidney Foundation, United States
CollaboratorOTHER
Taylor's University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in muscle statusBaseline versus 6 monthsEffect 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

MeasureTime frameDescription
Changes in malnutrition-inflammation complex syndromeBaseline versus 6 monthsEffect of ONS on improving malnutrition complex syndrome using Malnutrition-Inflammation Score (questionnaire) with lower ratings indicating well-nourished
Changes in anthropometric measuresBaseline versus 6 monthsEffect of ONS on improving post-dialysis weight and body mass index
Changes in nutrition-related biochemistry measuresBaseline versus 6 monthsEffect of ONS on improving serum albumin and serum prealbumin levels
Changes in dietary parametersBaseline versus 6 monthsEffect of ONS on improving dietary energy and protein intake assessed using 24-hour diet recall forms
Changes in quality of lifeBaseline versus 6 monthsEffect of ONS in improving quality of life assessed using the short form-36 questionnaire, with higher total score indicating better quality of life

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026