Effects of Immunonutrition in Patients With Pneumonia

Not Applicable

• Conditions: Lung Infection; Muscle Loss; Pulmonary Disease; Pneumonia; Malnutrition
• Interventions: Dietary Supplement: Oral Impact powder

• Registration Number: NCT04249050
• Lead Sponsor: University of Copenhagen

Brief Summary

The project is a randomized controlled trial taking place in the North Zealand hospital in the city Hilleroed, Denmark.

The aim is to investigate the potential beneficial effects of immunonutrition containing fish oil, arginine and RNA, on the acute immune response in patients with pneumonia.

Detailed Description

Immunonutrition has a well-documented beneficial effect on surgical patients by strengthening the immune system and reducing the following: inflammation, the number of infections as well as hospitalization time. A study in operated patients demonstrated the benefit of immunonutrition by reducing unwanted inflammation, measured by the pro-inflammatory signalling protein, interleukin-6. The same study saw a smaller decrease in immune function (measured as the level of phagocytosis) in the group receiving immunonutrition than in the control group. This project will investigate whether similar effects can be detected in patients with pneumonia.

The project is being carried out in a collaboration between the University of Copenhagen, The main hospital of Copenhagen (Rigshospitalet) and North Zealand Hospital. The project is a randomized clinical intervention study, which spans 10 days. Participants are allocated to the intervention group or the control group. The project is being carried out at the North Zealand hospital, at the Department of Pulmonary- and Infectious Diseases.

The intervention group receives the department's standard treatment (Standard Of Care) + immunonutrition, while the control group receives the hospital department's standard treatment (Standard Of Care). On a daily basis, the patient's clinical condition and the activity of the immune system is measured for the purpose of determine whether there is an effect of immunonutrition.

Study Timeline

• Study First Submitted: 2020-01-28
• Study First Submitted QC: 2020-01-29
• Study First Posted: 2020-01-30
• Study Start: 2020-03-30
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-24
• Last Update Posted: 2020-04-28
• Primary Completion: 2020-08-01
• Study Completion: 2020-08-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Authorized individuals diagnosed with pneumonia who speak and write in danish

Exclusion Criteria

• individuals with Immunodeficiency
• individuals with another primary diagnose
• individuals with an allergy against product ingredients
• individuals with dementia
• individuals with dysphagia
• individuals with cancer in treatment
• individuals with Chronic Obstructive Pulmonary Disease on continuing steroid treatment or home administered oxygen treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Oral Impact powder	The intervention group is receiving a nutritional drink containing potential immune stimulating ingredients (fish oil, arginine, nucleotides)

Primary Outcome Measures

Name	Time	Method
Interleukin-6	daily measure from first day of inclusion until discharge (maximum 10 days)	Measure of the acute immune response

Secondary Outcome Measures

Name	Time	Method
Hand grip strength	Daily from admittance to discharge (maximum 10 days)	Measure of the mobilization of strength
Length of stay	From admittance to discharge (maximum 10 days)	Measure of hospitalized days

Trial Locations

Locations (1)

Department of Lung Medicine and Infectious Diseases; 🇩🇰 Hillerød, Denmark