Effects of Immunonutrition in Patients With Pneumonia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Immunonutrition on the Acute Immune Response in Hospitalized Patients With Pneumonia

Conditions
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Pneumonia, Lung Infection, Muscle Loss, Malnutrition, Pulmonary Disease

Intervention / Treatment
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* Dietary Supplement: Oral Impact powder


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>The intervention group is receiving a nutritional drink containing potential immune stimulating ingredients (fish oil, arginine, nucleotides) | Dietary Supplement: Oral Impact powder<br>* Oral nutritional supplement containing fish oil, arginine and RNA<br>|
| No Intervention: Control group<br>The Control group is receiving the hospital´s Standard Of Care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interleukin-6 | Measure of the acute immune response | daily measure from first day of inclusion until discharge (maximum 10 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay | Measure of hospitalized days | From admittance to discharge (maximum 10 days) | 
| Hand grip strength | Measure of the mobilization of strength | Daily from admittance to discharge (maximum 10 days) |