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

NCT04789031 | Completed

• 2 other identifiers: NKF/2018/SBS/01NMRR-16-2525-32068
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Muscle Wasting; End Stage Renal Disease on Dialysis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Changes in malnutrition-inflammation complex syndrome

  Baseline versus 6 months

• Changes in anthropometric measures

  Baseline versus 6 months

• Changes in nutrition-related biochemistry measures

  Baseline versus 6 months

• Changes in dietary parameters

  Baseline versus 6 months

• Changes in quality of life

  Baseline versus 6 months

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Dietary Supplement: Oral nutritional supplementation (ONS)

Control group

NO INTERVENTION

Patients received standard nutritional counseling for 6 months.

Interventions

Oral nutritional supplementation (ONS) 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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taylor's University: lead
• National Kidney Foundation, United States: collaborator

Related Publications (10)

• 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.

  PMID: 30348259 BACKGROUND

• 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):3147. doi: 10.3390/nu12103147.

  PMID: 33076282 BACKGROUND

• 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, Trevino-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. doi: 10.1038/sj.ki.5002585. Epub 2007 Dec 19.

  PMID: 18094682 BACKGROUND

• 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.

  PMID: 23698226 BACKGROUND

• 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.

  PMID: 30212514 BACKGROUND

• 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):3597. doi: 10.3390/nu12113597.

  PMID: 33238633 BACKGROUND

• 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.

  PMID: 29866494 BACKGROUND

• 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(5):CD012616. doi: 10.1002/14651858.CD012616.pub2.

  PMID: 32390133 BACKGROUND

• 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. 2021 Apr;77(4):1716-1730. doi: 10.1111/jan.14684. Epub 2020 Dec 3.

  PMID: 33270269 BACKGROUND

• Sahathevan S, Karupaiah T, Khor BH, Sadu Singh BK, Mat Daud ZA, Fiaccadori E, Sabatino A, Chinna K, Abdul Gafor AH, Bavanandan S, Visvanathan R, Yahya R, Wahab Z, Goh BL, Morad Z, Bee BC, Wong HS. Muscle Status Response to Oral Nutritional Supplementation in Hemodialysis Patients With Protein Energy Wasting: A Multi-Center Randomized, Open Label-Controlled Trial. Front Nutr. 2021 Dec 10;8:743324. doi: 10.3389/fnut.2021.743324. eCollection 2021.

  PMID: 34977109 DERIVED

MeSH Terms

Conditions

Muscular Atrophy

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Tilakavati Karupaiah, PhD

  Taylor's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Dr Tilakavati Karupaiah

Model Details: 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.

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 9, 2021
• Study Start: June 1, 2016
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: March 9, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share