Liquid Nutritional Supplement on Malnutrition Hospitalized Patient

August 1, 2019 updated by: Marcellus Simadibrata, Prof. PhD., SpPD, KGEH, Fakultas Kedokteran Universitas Indonesia

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

138

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Liquid Nutritional Supplement from Hospital Product
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
Liquid Nutritional Supplement from Hospital Product is given 2 times daily for 14 days
Placebo Comparator: Placebo
This group received standard liquid nutritional supplement as a placebo. Placebo will be given 2 times daily for 14 days
Dietary supplement: Placebo
Standard nutritional supplement is given 2 times daily as placebo for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Body Mass Index (BMI)
Time Frame: 0 and 14 days
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
Time Frame: 0 and 14 days
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
Time Frame: 0 and 14 days
Body fat percentage is assessed by Bioelectrical Impedance Analysis (BIA)
0 and 14 days
Change of handgrip strength test score
Time Frame: 0 and 14 days
Handgrip strength is assessed by handgrip strength score.
0 and 14 days
Change of hemoglobin level
Time Frame: 0 and 14 days
Hemoglobin level is obtain from laboratory test
0 and 14 days
Change of prealbumin level
Time Frame: 0 and 14 days
Prealbumin level is obtain from laboratory test
0 and 14 days
Change of Blood Urea Nitrogen (BUN) level
Time Frame: 0 and 14 days
BUN level is obtain from laboratory test
0 and 14 days
Change of lipid profile level
Time Frame: 0 and 14 days
Lipid profile level is obtain from laboratory test
0 and 14 days
Change of blood glucose level
Time Frame: 0 and 14 days
Blood glucose level is obtain from laboratory test
0 and 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fakultas Kedokteran Universitas Indonesia

Investigators

  • Principal Investigator: Marcellus Simadibrata, Division Of Gastroenterology Department Of Internal Medicine Faculty Of Medicine Universitas Indonesia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2019

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

July 25, 2019

First Submitted That Met QC Criteria

July 25, 2019

First Posted (Actual)

July 30, 2019

Study Record Updates

Last Update Posted (Actual)

August 5, 2019

Last Update Submitted That Met QC Criteria

August 1, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-01-0082

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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