The Effectiveness of a High-Protein Liquid Dietary Supplementation

May 29, 2021 updated by: MARCELLUS SIMADIBRATA

The Effectiveness of a High-Protein Liquid Dietary Supplementation in Improving Nutritional Status of Malnourished Patients in Hospital Care: a Preliminary Study

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

138

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
        • Faculty of Medicine, Universitas Indonesia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Randomly selected malnourished patients for 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)
EXPERIMENTAL: Randomly selected Malnourished patients with high protein liquid diet supplementation
Malnourished patients with high protein liquid diet 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Right handgrip strength
Time Frame: Handgrip strength is assessed at day 10 of dietary administration supplementation in each arm
Handgrip strength in kg based on sex and age
Handgrip strength is assessed at day 10 of dietary administration supplementation in each arm
Adult malnutrition classification according to the WHO
Time Frame: 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)
the classification of malnutrition is assessed at day 10 of dietary supplementation in each arm
Nutritional status based on Subjective Global Assessment (SGA)
Time Frame: 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.
All SGA assesment is done at day 10 of dietary supplementation in each arm

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 25, 2019

Primary Completion (ACTUAL)

December 31, 2020

Study Completion (ACTUAL)

December 31, 2020

Study Registration Dates

First Submitted

April 1, 2021

First Submitted That Met QC Criteria

May 29, 2021

First Posted (ACTUAL)

June 3, 2021

Study Record Updates

Last Update Posted (ACTUAL)

June 3, 2021

Last Update Submitted That Met QC Criteria

May 29, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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