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

End Stage Renal Disease on Dialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04789031
• Other study ID #: NKF/2018/SBS/01
• Secondary ID: NMRR-16-2525-320
• Status: Completed
• Phase: N/A
• Start date: June 1, 2016
• Est. completion date: July 31, 2019

Study information

• Verified date: March 2021
• Source: Taylor's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cachexia
• End Stage Renal Disease on Dialysis
• Kidney Failure, Chronic
• Muscle Wasting
• Muscular Atrophy

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Taylor's University	National Kidney Foundation

References & Publications (9)

Carrero JJ, Thomas F, Nagy K, Arogundade F, Avesani CM, Chan M, Chmielewski M, Cordeiro AC, Espinosa-Cuevas A, Fiaccadori E, Guebre-Egziabher F, Hand RK, Hung AM, Ikizler TA, Johansson LR, Kalantar-Zadeh K, Karupaiah T, Lindholm B, Marckmann P, Mafra D, Parekh RS, Park J, Russo S, Saxena A, Sezer S, Teta D, Ter Wee PM, Verseput C, Wang AYM, Xu H, Lu Y, Molnar MZ, Kovesdy CP. Global Prevalence of Protein-Energy Wasting in Kidney Disease: A Meta-analysis of Contemporary Observational Studies From the International Society of Renal Nutrition and Metabolism. J Ren Nutr. 2018 Nov;28(6):380-392. doi: 10.1053/j.jrn.2018.08.006. — View Citation

Fouque D, Kalantar-Zadeh K, Kopple J, Cano N, Chauveau P, Cuppari L, Franch H, Guarnieri G, Ikizler TA, Kaysen G, Lindholm B, Massy Z, Mitch W, Pineda E, Stenvinkel P, Treviño-Becerra A, Wanner C. A proposed nomenclature and diagnostic criteria for protein-energy wasting in acute and chronic kidney disease. Kidney Int. 2008 Feb;73(4):391-8. Epub 2007 Dec 19. Erratum in: Kidney Int. 2008 Aug;74(3):393. Trevinho-Becerra, A [corrected to Treviño-Becerra, A]. — View Citation

Ikizler TA, Cano NJ, Franch H, Fouque D, Himmelfarb J, Kalantar-Zadeh K, Kuhlmann MK, Stenvinkel P, TerWee P, Teta D, Wang AY, Wanner C; International Society of Renal Nutrition and Metabolism. Prevention and treatment of protein energy wasting in chronic kidney disease patients: a consensus statement by the International Society of Renal Nutrition and Metabolism. Kidney Int. 2013 Dec;84(6):1096-107. doi: 10.1038/ki.2013.147. Epub 2013 May 22. Review. — View Citation

Liu PJ, Ma F, Wang QY, He SL. The effects of oral nutritional supplements in patients with maintenance dialysis therapy: A systematic review and meta-analysis of randomized clinical trials. PLoS One. 2018 Sep 13;13(9):e0203706. doi: 10.1371/journal.pone.0203706. eCollection 2018. — View Citation

Lu Y, Wang YJ, Lu Q. The effect of oral nutritional supplement on muscle fitness of patients undergoing dialysis: A systematic review and meta-analysis. J Adv Nurs. 2020 Dec 3. doi: 10.1111/jan.14684. [Epub ahead of print] Review. — View Citation

Mah JY, Choy SW, Roberts MA, Desai AM, Corken M, Gwini SM, McMahon LP. Oral protein-based supplements versus placebo or no treatment for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2020 May 11;5:CD012616. doi: 10.1002/14651858.CD012616.pub2. — View Citation

Sabatino A, Regolisti G, Delsante M, Di Motta T, Cantarelli C, Pioli S, Grassi G, Batini V, Gregorini M, Fiaccadori E. Noninvasive evaluation of muscle mass by ultrasonography of quadriceps femoris muscle in End-Stage Renal Disease patients on hemodialysis. Clin Nutr. 2019 Jun;38(3):1232-1239. doi: 10.1016/j.clnu.2018.05.004. Epub 2018 May 19. — View Citation

Sahathevan S, Khor BH, Ng HM, Gafor AHA, Mat Daud ZA, Mafra D, Karupaiah T. Understanding Development of Malnutrition in Hemodialysis Patients: A Narrative Review. Nutrients. 2020 Oct 15;12(10). pii: E3147. doi: 10.3390/nu12103147. Review. — View Citation

Sahathevan S, Khor BH, Singh BKS, Sabatino A, Fiaccadori E, Daud ZAM, Ali MS, Narayanan SS, Tallman D, Chinna K, Goh BL, Gafor AHA, Ahmad G, Morad Z, Khosla P, Karupaiah T, On Behalf Of The Patch Study Malaysia Investigators. Association of Ultrasound-Derived Metrics of the Quadriceps Muscle with Protein Energy Wasting in Hemodialysis Patients: A Multicenter Cross-Sectional Study. Nutrients. 2020 Nov 23;12(11). pii: E3597. doi: 10.3390/nu12113597. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in muscle status	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)	Baseline versus 6 months
Secondary	Changes in malnutrition-inflammation complex syndrome	Effect of ONS on improving malnutrition complex syndrome using Malnutrition-Inflammation Score (questionnaire) with lower ratings indicating well-nourished	Baseline versus 6 months
Secondary	Changes in anthropometric measures	Effect of ONS on improving post-dialysis weight and body mass index	Baseline versus 6 months
Secondary	Changes in nutrition-related biochemistry measures	Effect of ONS on improving serum albumin and serum prealbumin levels	Baseline versus 6 months
Secondary	Changes in dietary parameters	Effect of ONS on improving dietary energy and protein intake assessed using 24-hour diet recall forms	Baseline versus 6 months
Secondary	Changes in quality of life	Effect of ONS in improving quality of life assessed using the short form-36 questionnaire, with higher total score indicating better quality of life	Baseline versus 6 months