Effectivity of Liquid Nutritional Supplementation in Improving Nutritional Status of Hospitalized Malnutrition Patients: A Single-Blind Randomized Controlled Trial
Phase: NA
Conditions: Malnutrition
Sponsor: Fakultas Kedokteran Universitas Indonesia

  
 
  
STUDY PROTOCOL 
(July 30th 2019) 
 
Effectivity of Liquid Nutritional Supplementation in Improving 
Nutritional Status of Hospitalized Malnutrition Patients: A Single-
Blind Randomized Controlled Trial 
  
 
 
 
 
PRINCIPAL INVESTIGATOR : Prof. dr. Marcellus Simadibrata, PhD., SpPD-KGEH  
CO-INVESTIGATOR 
 
   : Prof. Dr. dr. Murdani Abdullah, SpPD-KGEH 
 
 
 
 
     dr. Amanda Pitarini Utari, SpPD-KGEH 
    dr. Virly Nanda Muzellina, SpPD   
 
Faculty of Medicine 
Universitas Indonesia 
(FMUI) 
 
 
2019  
 
 

 
 
Title 
Effectivity of Liquid Nutritional Supplementation in Improving Nutritional Status of Hospitalized 
Malnutrition Patients: A Single-Blind Randomized Controlled Trial 
Background 
Malnutrition is a common problem that is found in hospitalized patients. A study by Allard et al1 
found that in Canada, 45% of hospitalized patients had malnutrition. Another studies in Europe, 20-
30% of hospitalized patients also had malnutrition.2,3 Lim et al4 also conducted a study and found 
malnutrition in 27-39% subjects who were hospitalized. Malnutrition is a condition which there were 
unbalanced energy, protein or other nutrition that results in underweight or overweight. Malnutrition 
in hospitalized patients is due to unfullfiled nutrient intake, malabsorption, nutrient loss due to main 
disease or increased metabolic demand.5,6 
Recent studies showed that malnutrition increases morbidity and mortality. Malnutrition also 
extends hospitalisation duration and recovery time. These will increase hospitalisation cost.7-9 
Therefore, nutrition is an important key in malnutrition treatment. Nutritional supplementation can 
be given in improving nutritional status. Liquid form is a alternative in supplying nutrition to 
hospitalized patients since the consistency made it easier to swallow. Nowadays nutritional 
supplement in liquid form is available from commercial product or hospital product. Therefore, we 
need a study to know effectivity liquid nutritional supplement from hospital product in malnutrition 
hospitalized patients. 
  
Objective 
General objective 
To know the effectivity of liquid nutritional supplementation in malnutrition hospitalized patients 
Specific objectives 
1. To know the change of Body Mass Index (BMI) post liquid nutritional supplementation 
2. To know the change of Subjective Global Assessment (SGA) rank post liquid nutritional 
supplementation  
3. To know the change of hemoglobin level post liquid nutritional supplementation 
4. To know the change of prealbumin level post liquid nutritional supplementation 

5. To know the change of Blood Urea Nitrogen (BUN) level post liquid nutritional 
supplementation 
6. To know the change of lipid profile level post liquid nutritional supplementation 
7. To know the change of blood glucose level post liquid nutritional supplementation 
8. To know the change of body fat percentage post liquid nutritional supplementation 
9. To know the change of handgrip strength test score post liquid nutritional supplementation 
Methods 
Study Design 
This research is a single blind, randomized clinical trial method. Analysis will be conducted pre and 
post administration: control (standard liquid nutritional supplement as placebo), intervention (liquid 
nutritional supplement from hospital product) 2 times daily for 14 days. 
Location and Time 
This research will be conducted on Indonesia from August 2019 to December 2020 
Population and Subject 
Population 
The population of this research is hospitalized patients with malnutrition in Indonesia 
 
Subjects Criteria 
- 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 

Drop Out Criteria 
Drop out subjects are subjects who have signed the informed consent but decide to withdraw before 
research is completed  
 
Estimated Sample Size 
Minimum sample size is determined using the following equation for proportion equation. 
N1 = N2 =
(𝑍𝛼√2PQ + 𝑍𝛽√P1Q1 + P2Q2)2
(P1 −P2)2
 
Description :  
Zα = 1.96  
Zβ = 0.84  
P1-P2 = 0.2 
P1 = 0.1510 
N1 = N2  = 62.41, thus with predicted drop out 10% the minimal sample for each group is 69 
subjects 
 
Randomization  
Randomization is generated by computer and subjects will be given code and divided into two 
groups (control and intervention). Only researchers are blinded to treatment. Subjects can’t be 
blinded since the taste between intervention and placebo is obvious. 
Variables 
Independent Variables 
1. Intervention: administration of liquid nutritional supplement from hospital product 2 times 
daily 
2. Control (placebo): administration of standard nutritional product 2 times daily 
Dependent Variables 
1. Body Mass Index (BMI) 
2. Hemoglobin, prealbumin, Blood Urea Nitrogen (BUN), lipid profile, blood glucose from 
blood samples 
3. Subjective Global Assessment (SGA) rank 
4. Body fat percentage from Bioelectrical Impedance Analysis (BIA) 
5. Handgrip strength score from handgrip strength test 

Procedure 
1. Eligibility assessment 
The subjects will be assessed for eligibility using inclusion and exclusion criteria. 
2. Subjects sign the informed consent form 
3. Randomization 
4. Pre-administration 
6. Before administration of liquid nutritional supplement either from commercial or hospital 
product or placebo based on randomization, subjects will be analysed for his/her BMI, 
hemoglobin, prealbumin, Blood Urea Nitrogen (BUN), lipid profile, blood glucose, 
Subjective Global Assessment (SGA) rank, body fat percentage and handgrip strength score. 
Subject will also be examined for his/her skinfold and mid upper arm circumference.  
5. Administration (14 days) 
Subjects will be given liquid nutritional supplement and placebo that will be taken two times 
daily for 14 days.  
6. Compliance monitoring 
Compliance monitoring of administration is conducted by the investigators coordinating with 
his/her family, nurses and doctors in the hospital while patient is hospitalized 
7. Post administration  
After 14 days, the subjects will be analysed for his/her BMI, hemoglobin, prealbumin, Blood 
Urea Nitrogen (BUN), lipid profile, blood glucose, Subjective Global Assessment (SGA) 
rank, body fat percentage and handgrip strength score. 
8. Data analysis 
a. Normality analysis using Kolmogorov-Smirnov (Normally distributed if p>0.05) 
b. Bivariate analysis by comparing numeric data between two groups: if data is 
normality distributed using T-test, if not using Mann-Whitney test (significant if 
p<0.05) 
c. Bivariate analysis by comparing categorical data between two groups: if data is 
normality distributed using T-test, if not using Mann-Whitney test (significant if 
p<0.05) 
d. Bivariate analysis by comparing numeric data between preadministration and 
postadministration: if data is normality distributed using paired T-test, if not using 
Wilcoxon test (significant if p<0.05) 

e. Bivariate analysis by comparing categorical data between preadministration and 
postadministration: if data is normality distributed using Mc Nemar test, if not using 
Wilcoxon test (significant if p<0.05) 
Study flow chart 
 
 
 
 
Ethical committee approval  
Approval from the Ethical Committee at the Faculty of Medicine Universitas Indonesia must be 
obtained before starting the trial. 
References 
1. Allard JP, Keller H, Jeejeebhoy KN, et al. Malnutrition at Hospital Admission - Contributors 
and Effect on Length of Stay: A Prospective Cohort Study From the Canadian Malnutrition Task 
Malnutrition hospitalized 
patients 
Eligibility 
criteria 
Informed consent 
Day 0: BMI, hemoglobin, prealbumin, Blood Urea Nitrogen (BUN), lipid profile, 
blood glucose, Subjective Global Assessment (SGA) rank, body fat percentage and 
handgrip strength score assessment 
Randomization 
Control group: 
Standard nutritional supplement  
Intervetional 1 group: 
Liquid nutritional supplement from 
hospital products 
 
Day 14: BMI, hemoglobin, prealbumin, Blood Urea Nitrogen (BUN), lipid profile, 
blood glucose, Subjective Global Assessment (SGA) score, body fat percentage 
and handgrip strength score assessment 

Force. J Parenter Enter Nutr. 2015;40(4):487-497. 
2. Schindler K, Pernicka E, Laviano A, et al. 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;29(5):552-559. 
3. Álvarez-Hernández J, Planas Vila M, León-Sanz M, et al. Prevalence and costs of malnutrition 
in hospitalized patients; the PREDyCES Study. Nutr Hosp. 2012;27(4):1049-1059. 
4. Lim SL, Ong KCB, 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. 
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5. Meijers JMM, van Bokhorst-de van der Schueren MAE, Schols JMGA, Soeters PB, Halfens 
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