Effect of Oral Nutritional Supplementation Combined With Impedance Vectors

NCT05288101 | Completed DMC

• 1 other identifier: UAQ-ISSSTE-INCMNSZ-4423632676
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study was to assess the effect of oral nutritional supplementation (ONS) combined with bioelectrical vector analysis (BIVA) on the nutritional and hydration status and the quality of life (QoL) in hemodialysis (HD) patients. Design and Methods: Thirty-two chronic HD patients were included in a 6-month randomized pilot study. Patients in SUPL group received a simultaneous intervention consisting of a personalized diet, 245 mL/d ONS and dry weight adjustment through BIVA. Patients in CON group received a personalized diet and dry weight adjustment by BIVA. Anthropometrical, biochemical, dietary, QoL, handgrip strength (HGS) and bioimpedance measurements were performed. Malnutrition Inflammation Score (MIS) was applied.

Conditions

Chronic Kidney Disease Requiring Chronic Dialysis; Overhydration; Undernutrition

Keywords

Dry weight; Undernutrition; Bioelectrical vector analysis; Oral nutrition supplementation; Quality of life

Outcome Measures

Primary Outcomes (2)

• Change in nutritional status from baseline to 6 months

  Nutritional status was assessed by the Malnutrition Inflammation Score (MIS). MIS is a 27 points maximum scale. According to the total score obtained, the following diagnoses were considered: normal nutritional status (0 points), mild undernutrition (1 - 9 points), moderate undernutrition (10 - 19 points) and severe undernutrition (\> 20 points)

  At the beginning of the study (baseline) and at the end of the intervention (six months after starting the intervention).

• Change in hydration status from baseline to 6 months

  Hydration status was evaluated by bioelectrical impedance vector analysis (BIVA). BIA was measured immediately before the start and ten minutes after the end of the mid-week HD session, by the same trained personnel. Individual resistance and reactance values were standardized by the height of each patient (R/H, Xc/H) and then plotted on the reference ellipses of the Mexican population. Dehydration was considered when the vector was at the top, outside the 75% ellipses Overhydration was considered when the vector was at the bottom, outside the 75% ellipses Normohydration was considered when the vector was within the ellipses of 50 and 75%

  Every week through study completion (six months).

Secondary Outcomes (18)

• Change in Quality of life evaluation (KDQOL SF) from baseline to 6 months

  At the beginning of the study (baseline) and at the end of the intervention (six months after starting the intervention).

• Change in hand grip strength (HGS) from baseline to 6 months

  At the beginning of the study (baseline) and at the end of the intervention (six months after starting the intervention)

• Monthly change in gastrointestinal symptoms evaluation (GSQ) from baseline to 6 months

  Every month through study completion (six months).

• Monthly change in calorie intake from baseline to 6 months

  Every month through study completion (six months).

• Monthly change in protein intake from baseline to 6 months

  Every month through study completion (six months).

Study Arms (2)

Control

ACTIVE COMPARATOR

Patients in CON group received a personalized diet and dry weight adjustment by BIVA. Anthropometrical, biochemical, dietary, QoL, handgrip strength (HGS) and bioimpedance measurements were performed. Malnutrition Inflammation Score (MIS) was applied

Procedure: Dry weight adjustment through BIVA

Supplemented

EXPERIMENTAL

Patients in SUPL group received a simultaneous intervention consisting of a personalized diet, 245 mL/d ONS and dry weight adjustment through BIVA, Anthropometrical, biochemical, dietary, QoL, handgrip strength (HGS) and bioimpedance measurements were performed. Malnutrition Inflammation Score (MIS) was applied

Dietary Supplement: Proteinex and Enterex DBT Victus Laboratories; Procedure: Dry weight adjustment through BIVA

Interventions

Proteinex and Enterex DBT Victus Laboratories DIETARY_SUPPLEMENT

The supplement was provided five days per week. Three days a week, the supplement was given at the beginning of the HD session and the patients were instructed to consume it slowly during the next 3 hours. The remaining two days, the supplement was consumed at home and instructed to be consumed between meals. The ONS consisted of one can of polymeric formula (Enterex DBT, Victus Laboratories) and 5.6 g of a protein powder supplement (Proteinex, Victus Laboratories). The final mixture provided 240 kcal, 17 g protein, 8.1 g lipids, 25 g carbohydrates, 4 g dietary fiber, 201 mg sodium, 490 mg calcium, 356 mg phosphorus and 371 mg potassium

Supplemented

Dry weight adjustment through BIVA PROCEDURE

Those participants with post-dialysis vectors located within the 50 or 75% ellipses, were considered to be in dry weight, so they did not require any fluid removal adjustment. However, participants with vectors outside the 75% ellipse were considered overhydrated or dehydrated and dry weight was adjusted. In these patients, if the vectors fell outside the 75% ellipse but within the 95%, above or below the major axis, the established dry weight was adjusted by 0.5 Kg. If the vectors fell outside the 95% ellipse, the weight was adjusted by 1.0 Kg.

Control; Supplemented

Eligibility Criteria

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

You may qualify if:

• Patients on chronic HD undergoing thrice weekly hemodialysis (at least three hours per treatment) for more than three months were included.

You may not qualify if:

• Patients with amputations of any limb, metal implants, diagnosis of dementia, or current consumption of nutritional supplements were excluded.

Sponsors & Collaborators

• Universidad Autonoma de Queretaro: lead
• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: collaborator
• Indiana University School of Medicine: collaborator
• Ball State University: collaborator

Study Sites (1)

HD unit of the Social Security Institute for Government Employees (ISSSTE as per initials in Spanish

Querétaro, 76000, Mexico

Location

Related Publications (8)

• Nieves-Anaya I, Vargas MB, Mayorga H, Garcia OP, Colin-Ramirez E, Atilano-Carsi X. Comparison of nutritional and hydration status in patients undergoing twice and thrice-weekly hemodialysis: a silent drama in developing countries. Int Urol Nephrol. 2021 Mar;53(3):571-581. doi: 10.1007/s11255-020-02697-3. Epub 2021 Jan 4.

  PMID: 33394280 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 RESULT

• Hanna RM, Ghobry L, Wassef O, Rhee CM, Kalantar-Zadeh K. A Practical Approach to Nutrition, Protein-Energy Wasting, Sarcopenia, and Cachexia in Patients with Chronic Kidney Disease. Blood Purif. 2020;49(1-2):202-211. doi: 10.1159/000504240. Epub 2019 Dec 18.

  PMID: 31851983 RESULT

• Kalantar-Zadeh K, Ikizler TA, Block G, Avram MM, Kopple JD. Malnutrition-inflammation complex syndrome in dialysis patients: causes and consequences. Am J Kidney Dis. 2003 Nov;42(5):864-81. doi: 10.1016/j.ajkd.2003.07.016.

  PMID: 14582032 RESULT

• 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 RESULT

• Sabatino A, Regolisti G, Karupaiah T, Sahathevan S, Sadu Singh BK, Khor BH, Salhab N, Karavetian M, Cupisti A, Fiaccadori E. Protein-energy wasting and nutritional supplementation in patients with end-stage renal disease on hemodialysis. Clin Nutr. 2017 Jun;36(3):663-671. doi: 10.1016/j.clnu.2016.06.007. Epub 2016 Jun 18.

  PMID: 27371993 RESULT

• Pupim LB, Majchrzak KM, Flakoll PJ, Ikizler TA. Intradialytic oral nutrition improves protein homeostasis in chronic hemodialysis patients with deranged nutritional status. J Am Soc Nephrol. 2006 Nov;17(11):3149-57. doi: 10.1681/ASN.2006040413. Epub 2006 Oct 4.

  PMID: 17021267 RESULT

• Atilano-Carsi X, Miguel JL, Martinez Ara J, Sanchez Villanueva R, Gonzalez Garcia E, Selgas Gutierrez R. [Bioimpedance vector analysis as a tool for the determination and adjustment of dry weight in patients undergoing hemodialysis]. Nutr Hosp. 2015 May 1;31(5):2220-9. doi: 10.3305/nh.2015.31.5.8649. Spanish.

  PMID: 25929397 RESULT

MeSH Terms

Conditions

Water Intoxication; Malnutrition

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Poisoning; Chemically-Induced Disorders; Nutrition Disorders

Study Officials

• Ximena Atilano-Carsi, PhD

  Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Thirty-two chronic HD patients were included in a 6-month randomized pilot study. Patients in SUPL group received a simultaneous intervention consisting of a personalized diet, 245 mL/d ONS and dry weight adjustment through BIVA. Patients in CON group received a personalized diet and dry weight adjustment by BIVA. Anthropometrical, biochemical, dietary, QoL, handgrip strength (HGS) and bioimpedance measurements were performed. Malnutrition Inflammation Score (MIS) was applied.

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: March 18, 2022
• Study Start: January 1, 2017
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: March 18, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)