Muscle Status to Oral Nutritional Supplementation in Hemodialysis Patients With Protein Energy Wasting
- Conditions
- Muscle WastingEnd Stage Renal Disease on Dialysis
- Interventions
- Dietary Supplement: Oral nutritional supplementation (ONS)
- Registration Number
- NCT04789031
- Lead Sponsor
- Taylor's University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group Oral nutritional supplementation (ONS) Patients received oral nutritional supplementation and standard nutritional counseling for 6 months.
- Primary Outcome Measures
Name Time Method 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
Name Time Method Changes in nutrition-related biochemistry measures Baseline versus 6 months Effect of ONS on improving serum albumin and serum prealbumin levels
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 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
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 anthropometric measures Baseline versus 6 months Effect of ONS on improving post-dialysis weight and body mass index