The Effectiveness of a High-Protein Liquid Dietary Supplementation

Malnutrition Clinical Trial

Official title:

The Effectiveness of a High-Protein Liquid Dietary Supplementation in Improving Nutritional Status of Malnourished Patients in Hospital Care: a Preliminary Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04911712
• Other study ID #: KET-313/UN2.F1/ETIK
• Status: Completed
• Phase: N/A
• Start date: March 25, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2021
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Subjects aged = 18 years old to 60 years old

2. Malnutrition hospitalized patient based on European Society for Clinical Nutrition and Metabolism (ESPEN) 2015 criteria

3. Agreed to participate

Exclusion Criteria:

1. Malignancy

2. Chronic kidney disease stage III-V

3. Decompensated hepatic cirrhosis

4. Allergic to milk or lactose intolerance

5. Could not be randomised and participate in this study by clinical judgement

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• a hospital formula of normal protein liquid diet supplementation
group 1 (control group) who will get a hospital formula of normal protein liquid diet supplementation (40 grams per 1000 mL)
• a hospital formula of high protein liquid food supplementation
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)

Locations

Country	Name	City	State
Indonesia	Faculty of Medicine, Universitas Indonesia	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
MARCELLUS SIMADIBRATA

Country where clinical trial is conducted

Indonesia, 

References & Publications (10)

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. — View Citation

Álvarez-Hernández J, Planas Vila M, León-Sanz M, García de Lorenzo A, Celaya-Pérez S, García-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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Schindler K, Pernicka E, Laviano A, Howard P, Schütz 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. — View Citation

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. Review. Erratum in: Lancet. 2004 Mar 13;363(9412):902. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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