The Effectiveness of a High-Protein Liquid Dietary Supplementation

MARCELLUS SIMADIBRATA

Status: Completed

Conditions: Nutritional Status; Malnutrition; Nutrition Assessment; Body Mass Index; Hand Strength; Hospital

Treatments: Dietary Supplement: a hospital formula of high protein liquid food supplementation; Dietary Supplement: a hospital formula of normal protein liquid diet supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT04911712

KET-313/UN2.F1/ETIK

Details and patient eligibility

About

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.

Enrollment: 138 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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138 participants in 2 patient groups

Randomly selected malnourished patients for normal protein liquid diet supplementation

Active Comparator group

Description:

Randomly selected malnourished patients for normal protein liquid diet supplementation

Treatment:

Dietary Supplement: a hospital formula of normal protein liquid diet supplementation

Randomly selected Malnourished patients with high protein liquid diet supplementation

Experimental group

Description:

Malnourished patients with high protein liquid diet supplementation

Treatment:

Dietary Supplement: a hospital formula of high protein liquid food supplementation