Body Mass Index, Hand Strength, Hospital, Malnutrition, Nutritional Status, Nutrition Assessment
Conditions
Keywords
Malnutrition, high-protein diet, nutritional status, hospitals, hand strength, body mass index, nutrition assessment, preliminary data
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.
Interventions
DIETARY_SUPPLEMENTa hospital formula of normal protein liquid diet supplementation
group 1 (control group) who will get a hospital formula of normal protein liquid diet supplementation (40 grams per 1000 mL)
DIETARY_SUPPLEMENTa hospital formula of high protein liquid food supplementation
group 2 (intervention group) will get a hospital formula of high protein liquid food supplementation (60 grams per 1000 mL) as much as 2 bottles (each bottle contains 200 mL)
Sponsors
MARCELLUS SIMADIBRATA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Intervention model description
a Preliminary Study
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Indonesia
Outcome results
None listed