The Effectiveness of a High-Protein Liquid Dietary Supplementation

Study Overview
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Brief Summary
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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.

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

Conditions
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Malnutrition, Nutritional Status, Hospital, Hand Strength, Body Mass Index, Nutrition Assessment

Intervention / Treatment
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* Dietary Supplement: a hospital formula of normal protein liquid diet supplementation
* Dietary Supplement: a hospital formula of high protein liquid food supplementation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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
Interventional Model Description: a Preliminary Study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Randomly selected malnourished patients for normal protein liquid diet supplementation<br>Randomly selected malnourished patients for normal protein liquid diet supplementation | Dietary Supplement: a hospital formula of normal protein liquid diet supplementation<br>* group 1 (control group) who will get a hospital formula of normal protein liquid diet supplementation (40 grams per 1000 mL)<br>|
| Experimental: Randomly selected Malnourished patients with high protein liquid diet supplementation<br>Malnourished patients with high protein liquid diet supplementation | Dietary Supplement: a hospital formula of high protein liquid food supplementation<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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body mass index, nutrition assessment, preliminary data, Malnutrition, high-protein diet, nutritional status, hospitals, hand strength