Liquid Nutritional Supplement on Malnutrition Hospitalized Patient

Study Overview
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Brief Summary
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The aim of this study is to know the effectivity of liquid nutritional supplementation in malnutrition hospitalized patients

Official Title
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Effectivity of Liquid Nutritional Supplementation in Improving Nutritional Status of Hospitalized Malnutrition Patients: A Single-Blind Randomized Controlled Trial

Conditions
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Malnutrition

Intervention / Treatment
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* Dietary Supplement: Liquid Nutritional Supplement from Hospital Product
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liquid Nutritional Supplement from Hospital Product<br>This group received liquid nutritional supplement from hospital product. The product is in a form of low lactose milk ready to drink with volume 200 ml and will be given 2 times daily for 14 days. This product is consist of 1.017 kcal/ml, 10 vitamin and 9 mineral | Dietary Supplement: Liquid Nutritional Supplement from Hospital Product<br>* Liquid Nutritional Supplement from Hospital Product is given 2 times daily for 14 days<br>|
| Placebo Comparator: Placebo<br>This group received standard liquid nutritional supplement as a placebo. Placebo will be given 2 times daily for 14 days | Dietary Supplement: Placebo<br>* Standard nutritional supplement is given 2 times daily as placebo for 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Body Mass Index (BMI) | BMI was assessed from height and body calculation. Classification of BMI is based on World Health Organization (WHO) classification. | 0 and 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Subjective Global Assessment (SGA) rank | SGA rank is classified to A (well nourished), B (moderately malnourished) and C (severely malnourished) and these option are chosen based on history and physical examination that are stated in the SGA form. | 0 and 14 days | 
| Change of body fat percentage | Body fat percentage is assessed by Bioelectrical Impedance Analysis (BIA) | 0 and 14 days | 
| Change of handgrip strength test score | Handgrip strength is assessed by handgrip strength score. | 0 and 14 days | 
| Change of hemoglobin level | Hemoglobin level is obtain from laboratory test | 0 and 14 days | 
| Change of prealbumin level | Prealbumin level is obtain from laboratory test | 0 and 14 days | 
| Change of Blood Urea Nitrogen (BUN) level | BUN level is obtain from laboratory test | 0 and 14 days | 
| Change of lipid profile level | Lipid profile level is obtain from laboratory test | 0 and 14 days | 
| Change of blood glucose level | Blood glucose level is obtain from laboratory test | 0 and 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liquid Nutritional Supplement