Liquid Nutritional Supplement on Malnutrition Hospitalized Patient

Not Applicable

• Conditions: Malnutrition
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Liquid Nutritional Supplement from Hospital Product

• Registration Number: NCT04036825
• Lead Sponsor: Fakultas Kedokteran Universitas Indonesia

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-25
• Study First Submitted QC: 2019-07-25
• Study First Posted: 2019-07-30
• Status Verified: 2019-08
• Study Start: 2019-08
• Last Update Submitted: 2019-08-01
• Last Update Posted: 2019-08-05
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 138

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	This group received standard liquid nutritional supplement as a placebo. Placebo will be given 2 times daily for 14 days
Liquid Nutritional Supplement from Hospital Product	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

Primary Outcome Measures

Name	Time	Method
Change of Body Mass Index (BMI)	0 and 14 days	BMI was assessed from height and body calculation. Classification of BMI is based on World Health Organization (WHO) classification.

Secondary Outcome Measures

Name	Time	Method
Change of Subjective Global Assessment (SGA) rank	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.
Change of body fat percentage	0 and 14 days	Body fat percentage is assessed by Bioelectrical Impedance Analysis (BIA)
Change of handgrip strength test score	0 and 14 days	Handgrip strength is assessed by handgrip strength score.
Change of hemoglobin level	0 and 14 days	Hemoglobin level is obtain from laboratory test
Change of prealbumin level	0 and 14 days	Prealbumin level is obtain from laboratory test
Change of lipid profile level	0 and 14 days	Lipid profile level is obtain from laboratory test
Change of blood glucose level	0 and 14 days	Blood glucose level is obtain from laboratory test
Change of Blood Urea Nitrogen (BUN) level	0 and 14 days	BUN level is obtain from laboratory test

Trial Locations

Locations (1)

RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital); 🇮🇩 Jakarta Pusat, Indonesia