Clinical trial NCT04789031: Muscle Status to Oral Nutritional Supplementation in Hemodialysis Patients With Protein Energy Wasting
Official title: Muscle Status to Oral Nutritional Supplementation in Hemodialysis Patients With Protein Energy Wasting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Wasting
End Stage Renal Disease on Dialysis
Keywords: hemodialysis
protein energy wasting
oral nutritional supplementation
ultrasound imaging
Lead sponsor: Taylor's University
Sponsor class: OTHER
Collaborators: name: National Kidney Foundation, United States
First posted: 2021-03-09
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in muscle status
timeFrame: Baseline versus 6 months
Secondary outcomes:
measure: Changes in malnutrition-inflammation complex syndrome
timeFrame: Baseline versus 6 months
measure: Changes in anthropometric measures
timeFrame: Baseline versus 6 months
measure: Changes in nutrition-related biochemistry measures
timeFrame: Baseline versus 6 months
measure: Changes in dietary parameters
timeFrame: Baseline versus 6 months
measure: Changes in quality of life
timeFrame: Baseline versus 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Taylor's University
name: Tilakavati Karupaiah, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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