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NCT Number: NCT04911712

The Effectiveness of a High-Protein Liquid Dietary Supplementation

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.

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Key information

Conditions

Malnutrition Body Mass Index Hand Strength Hospital Nutrition Assessment Nutrition Disorders Nutritional Status Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Universitas Indonesia

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

a hospital formula of normal protein liquid diet supplementation

Dietary Supplement

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

a hospital formula of high protein liquid food supplementation

Dietary Supplement

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 outcomes

  1. 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

  2. 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)

  3. 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.

Sponsors and collaborators

Lead sponsor

MARCELLUS SIMADIBRATA

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 3, 2021
Registry last updated
Jun 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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