The Effectiveness of a High-Protein Liquid Dietary Supplementation

Not Applicable

Completed

• Conditions: Hospital; Nutrition Assessment; Body Mass Index; Hand Strength; Malnutrition; Nutritional Status
• Interventions: Dietary Supplement: a hospital formula of normal protein liquid diet supplementation; Dietary Supplement: a hospital formula of high protein liquid food supplementation

• Registration Number: NCT04911712
• Lead Sponsor: MARCELLUS SIMADIBRATA

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-25
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Study First Submitted: 2021-04-01
• Status Verified: 2021-05
• Study First Submitted QC: 2021-05-29
• Last Update Submitted: 2021-05-29
• Study First Posted: 2021-06-03
• Last Update Posted: 2021-06-03

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Randomly selected malnourished patients for normal protein liquid diet supplementation	a hospital formula of normal protein liquid diet supplementation	Randomly selected malnourished patients for normal protein liquid diet supplementation
Randomly selected Malnourished patients with high protein liquid diet supplementation	a hospital formula of high protein liquid food supplementation	Malnourished patients with high protein liquid diet supplementation

Primary Outcome Measures

Name	Time	Method
Right handgrip strength	Handgrip strength is assessed at day 10 of dietary administration supplementation in each arm	Handgrip strength in kg based on sex and age
Adult malnutrition classification according to the WHO	the classification of malnutrition is assessed at day 10 of dietary supplementation in each arm	The classification of Adult malnutrition according to the WHO based on BMI which categorized into (mild,moderate or severe)
Nutritional status based on Subjective Global Assessment (SGA)	All SGA assesment is done at day 10 of dietary supplementation in each arm	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.

Trial Locations

Locations (1)

Faculty of Medicine, Universitas Indonesia; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia