Clinical trial NCT04911712: The Effectiveness of a High-Protein Liquid Dietary Supplementation
Official title: The Effectiveness of a High-Protein Liquid Dietary Supplementation in Improving Nutritional Status of Malnourished Patients in Hospital Care: a Preliminary Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Nutritional Status
Hospital
Hand Strength
Body Mass Index
Nutrition Assessment
Keywords: Malnutrition
high-protein diet
nutritional status
hospitals
hand strength
body mass index
nutrition assessment
preliminary data
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2021-06-03
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a Preliminary Study
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Right handgrip strength
timeFrame: Handgrip strength is assessed at day 10 of dietary administration supplementation in each arm
measure: Adult malnutrition classification according to the WHO
timeFrame: the classification of malnutrition is assessed at day 10 of dietary supplementation in each arm
measure: Nutritional status based on Subjective Global Assessment (SGA)
timeFrame: All SGA assesment is done at day 10 of dietary supplementation in each arm
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Faculty of Medicine, Universitas Indonesia
state: DKI Jakarta
Study officials:
References:
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