The Effectiveness of a High-Protein Liquid Dietary Supplementation

MARCELLUS SIMADIBRATA138 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

138

Conditions

Malnutrition Nutritional Status Hospital Hand Strength Body Mass Index

Interventions

a hospital formula of normal protein liquid diet supplementationDIETARY_SUPPLEMENT

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 supplementationDIETARY_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)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Right handgrip strength

Handgrip strength in kg based on sex and age

Time frame: 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)

Time frame: 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.

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