The Effectiveness of a High-Protein Liquid Dietary Supplementation

NCT04911712 | Completed DMC

• 1 other identifier: KET-313/UN2.F1/ETIK
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

This study was a double-blind randomized controlled trial conducted to assess the effectiveness of high protein liquid dietary supplementation in malnourished hospitalized patients. The patients were assessed for their nutritional status based on ESPEN 2015 criteria. Patients who experienced malnutrition will be divided into 2 groups, namely the control group which was given a normal protein liquid diet, while the intervention group was given high protein liquid diet supplementation as much as 2 bottles (200 mL) per day for 7-10 days. Furthermore, the nutritional status of the patient was assessed.

Conditions

Malnutrition; Nutritional Status; Hospital; Hand Strength; Body Mass Index; Nutrition Assessment

Keywords

Malnutrition; high-protein diet; nutritional status; hospitals; hand strength; body mass index; nutrition assessment; preliminary data

Outcome Measures

Primary Outcomes (3)

• Right handgrip strength

  Handgrip strength in kg based on sex and age

  Handgrip strength is assessed at day 10 of dietary administration supplementation in each arm

• Adult malnutrition classification according to the WHO

  The classification of Adult malnutrition according to the WHO based on BMI which categorized into (mild,moderate or severe)

  the classification of malnutrition is assessed at day 10 of dietary supplementation in each arm

• Nutritional status based on Subjective Global Assessment (SGA)

  the Nutritional status based on Subjective Global Assessment (SGA). Group A is classified as Normal/ well-nourished. Group B is classified as Mild-Moderate nutrition. Group C is classified as Severe malnutrition.

  All SGA assesment is done at day 10 of dietary supplementation in each arm

Study Arms (2)

Randomly selected malnourished patients for normal protein liquid diet supplementation

ACTIVE COMPARATOR

Randomly selected malnourished patients for normal protein liquid diet supplementation

Dietary Supplement: a hospital formula of normal protein liquid diet supplementation

Randomly selected Malnourished patients with high protein liquid diet supplementation

EXPERIMENTAL

Malnourished patients with high protein liquid diet supplementation

Dietary Supplement: a hospital formula of high protein liquid food supplementation

Interventions

a hospital formula of normal protein liquid diet supplementation DIETARY_SUPPLEMENT

group 1 (control group) who will get a hospital formula of normal protein liquid diet supplementation (40 grams per 1000 mL)

Randomly selected malnourished patients for normal protein liquid diet supplementation

a hospital formula of high protein liquid food supplementation DIETARY_SUPPLEMENT

group 2 (intervention group) will get a hospital formula of high protein liquid food supplementation (60 grams per 1000 mL) as much as 2 bottles (each bottle contains 200 mL)

Randomly selected Malnourished patients with high protein liquid diet supplementation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects aged ≥ 18 years old to 60 years old
• Malnutrition hospitalized patient based on European Society for Clinical Nutrition and Metabolism (ESPEN) 2015 criteria
• Agreed to participate

You may not qualify if:

• Malignancy
• Chronic kidney disease stage III-V
• Decompensated hepatic cirrhosis
• Allergic to milk or lactose intolerance
• Could not be randomised and participate in this study by clinical judgement

Sponsors & Collaborators

• MARCELLUS SIMADIBRATA: lead

Study Sites (1)

Faculty of Medicine, Universitas Indonesia

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Related Publications (10)

• Meijers JM, van Bokhorst-de van der Schueren MA, Schols JM, Soeters PB, Halfens RJ. Defining malnutrition: mission or mission impossible? Nutrition. 2010 Apr;26(4):432-40. doi: 10.1016/j.nut.2009.06.012. Epub 2009 Dec 1.

  PMID: 19954929 BACKGROUND

• Allard JP, Keller H, Jeejeebhoy KN, Laporte M, Duerksen DR, Gramlich L, Payette H, Bernier P, Vesnaver E, Davidson B, Teterina A, Lou W. Malnutrition at Hospital Admission-Contributors and Effect on Length of Stay: A Prospective Cohort Study From the Canadian Malnutrition Task Force. JPEN J Parenter Enteral Nutr. 2016 May;40(4):487-97. doi: 10.1177/0148607114567902. Epub 2015 Jan 26.

  PMID: 25623481 BACKGROUND

• Alvarez-Hernandez J, Planas Vila M, Leon-Sanz M, Garcia de Lorenzo A, Celaya-Perez S, Garcia-Lorda P, Araujo K, Sarto Guerri B; PREDyCES researchers. Prevalence and costs of malnutrition in hospitalized patients; the PREDyCES Study. Nutr Hosp. 2012 Jul-Aug;27(4):1049-59. doi: 10.3305/nh.2012.27.4.5986.

  PMID: 23165541 BACKGROUND

• Schindler K, Pernicka E, Laviano A, Howard P, Schutz T, Bauer P, Grecu I, Jonkers C, Kondrup J, Ljungqvist O, Mouhieddine M, Pichard C, Singer P, Schneider S, Schuh C, Hiesmayr M; NutritionDay Audit Team. How nutritional risk is assessed and managed in European hospitals: a survey of 21,007 patients findings from the 2007-2008 cross-sectional nutritionDay survey. Clin Nutr. 2010 Oct;29(5):552-9. doi: 10.1016/j.clnu.2010.04.001.

  PMID: 20434820 BACKGROUND

• Lim SL, Ong KC, Chan YH, Loke WC, Ferguson M, Daniels L. Malnutrition and its impact on cost of hospitalization, length of stay, readmission and 3-year mortality. Clin Nutr. 2012 Jun;31(3):345-50. doi: 10.1016/j.clnu.2011.11.001. Epub 2011 Nov 26.

  PMID: 22122869 BACKGROUND

• Garber AK, Mauldin K, Michihata N, Buckelew SM, Shafer MA, Moscicki AB. Higher calorie diets increase rate of weight gain and shorten hospital stay in hospitalized adolescents with anorexia nervosa. J Adolesc Health. 2013 Nov;53(5):579-84. doi: 10.1016/j.jadohealth.2013.07.014. Epub 2013 Sep 17.

  PMID: 24054812 BACKGROUND

• WHO Expert Consultation. Appropriate body-mass index for Asian populations and its implications for policy and intervention strategies. Lancet. 2004 Jan 10;363(9403):157-63. doi: 10.1016/S0140-6736(03)15268-3.

  PMID: 14726171 BACKGROUND

• Cederholm T, Bosaeus I, Barazzoni R, Bauer J, Van Gossum A, Klek S, Muscaritoli M, Nyulasi I, Ockenga J, Schneider SM, de van der Schueren MA, Singer P. Diagnostic criteria for malnutrition - An ESPEN Consensus Statement. Clin Nutr. 2015 Jun;34(3):335-40. doi: 10.1016/j.clnu.2015.03.001. Epub 2015 Mar 9.

  PMID: 25799486 BACKGROUND

• Detsky AS, McLaughlin JR, Baker JP, Johnston N, Whittaker S, Mendelson RA, Jeejeebhoy KN. What is subjective global assessment of nutritional status? JPEN J Parenter Enteral Nutr. 1987 Jan-Feb;11(1):8-13. doi: 10.1177/014860718701100108.

  PMID: 3820522 BACKGROUND

• Huynh DT, Devitt AA, Paule CL, Reddy BR, Marathe P, Hegazi RA, Rosales FJ. Effects of oral nutritional supplementation in the management of malnutrition in hospital and post-hospital discharged patients in India: a randomised, open-label, controlled trial. J Hum Nutr Diet. 2015 Aug;28(4):331-43. doi: 10.1111/jhn.12241. Epub 2014 May 9.

  PMID: 24809429 BACKGROUND

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. dr. Marcellus Simadibrata Ph.D, Sp.PD-KGEH

Model Details: a Preliminary Study

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: June 3, 2021
• Study Start: March 25, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: June 3, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)