The Effectiveness of a High-Protein Liquid Dietary Supplementation
NCT ID: NCT04911712
Last Updated: 2021-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
138 participants
INTERVENTIONAL
2019-03-25
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Randomly selected malnourished patients for normal protein liquid diet supplementation
Randomly selected malnourished patients for normal protein liquid diet supplementation
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)
Randomly selected Malnourished patients with high protein liquid diet supplementation
Malnourished patients with high protein liquid diet supplementation
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
2. Malnutrition hospitalized patient based on European Society for Clinical Nutrition and Metabolism (ESPEN) 2015 criteria
3. Agreed to participate
Exclusion Criteria
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
18 Years
60 Years
ALL
No
Sponsors
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MARCELLUS SIMADIBRATA
OTHER
Responsible Party
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MARCELLUS SIMADIBRATA
Prof. dr. Marcellus Simadibrata Ph.D, Sp.PD-KGEH
Locations
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Faculty of Medicine, Universitas Indonesia
Jakarta Pusat, DKI Jakarta, Indonesia
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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KET-313/UN2.F1/ETIK
Identifier Type: -
Identifier Source: org_study_id
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