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The Effectiveness of a High-Protein Liquid Dietary Supplementation

Primary Purpose

Malnutrition, Nutritional Status, Hospital

Status

Completed

Phase

Not Applicable

Locations

Indonesia

Study Type

Interventional

Intervention

a hospital formula of normal protein liquid diet supplementation

a hospital formula of high protein liquid food supplementation

About this trial

This is an interventional treatment trial for Malnutrition focused on measuring Malnutrition, high-protein diet, nutritional status, hospitals, hand strength, body mass index, nutrition assessment, preliminary data

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects 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

Sites / Locations

Faculty of Medicine, Universitas Indonesia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Randomly selected malnourished patients for normal protein liquid diet supplementation

Randomly selected Malnourished patients with high protein liquid diet supplementation

Arm Description

Randomly selected malnourished patients for normal protein liquid diet supplementation

Malnourished patients with high protein liquid diet supplementation

Outcomes

Primary Outcome Measures

Right handgrip strength

Handgrip strength in kg based on sex and age

Adult malnutrition classification according to the WHO

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)

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04911712

First Posted

April 1, 2021

Last Updated

May 29, 2021

Sponsor

MARCELLUS SIMADIBRATA

1. Study Identification

Unique Protocol Identification Number

NCT04911712

Brief Title

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

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

March 25, 2019 (Actual)

Primary Completion Date

December 31, 2020 (Actual)

Study Completion Date

December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

MARCELLUS SIMADIBRATA

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

a Preliminary Study

Masking

Care ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

138 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Randomly selected malnourished patients for normal protein liquid diet supplementation

Arm Type

Active Comparator

Arm Description

Randomly selected malnourished patients for normal protein liquid diet supplementation

Arm Title

Randomly selected Malnourished patients with high protein liquid diet supplementation

Arm Type

Experimental

Arm Description

Malnourished patients with high protein liquid diet supplementation

Intervention Type

Dietary Supplement

Intervention Name(s)

a hospital formula of normal protein liquid diet supplementation

Intervention Description

group 1 (control group) who will get a hospital formula of normal protein liquid diet supplementation (40 grams per 1000 mL)

Intervention Type

Dietary Supplement

Intervention Name(s)

a hospital formula of high protein liquid food supplementation

Intervention Description

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)

Primary Outcome Measure Information:

Title

Right handgrip strength

Description

Handgrip strength in kg based on sex and age

Time Frame

Handgrip strength is assessed at day 10 of dietary administration supplementation in each arm

Title

Adult malnutrition classification according to the WHO

Description

The classification of Adult malnutrition according to the WHO based on BMI which categorized into (mild,moderate or severe)

Time Frame

the classification of malnutrition is assessed at day 10 of dietary supplementation in each arm

Title

Nutritional status based on Subjective Global Assessment (SGA)

Description

Time Frame

All SGA assesment is done at day 10 of dietary supplementation in each arm

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects 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

Facility Information:

Facility Name

Faculty of Medicine, Universitas Indonesia

City

Jakarta Pusat

State/Province

DKI Jakarta

ZIP/Postal Code

10430

Country

Indonesia

12. IPD Sharing Statement

Plan to Share IPD

Citations:

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19954929

Citation

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Citation

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Citation

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Citation

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The Effectiveness of a High-Protein Liquid Dietary Supplementation

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