Effect of Immune-enhancing Enteral Nutrition on Immunomodulation in Critically Ill Patients

Study Overview
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Brief Summary
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To determine whether high-protein (24% of total calorie from protein) enteral nutrition of immune modulating nutrients (eg, ω-3 fatty acids and antioxidants) enriched with β-glucan stimulates immune functions compared with standard enteral nutrition (control: 20% of total calorie from protein) or high-protein (24% of total calorie from protein) enteral nutrition of immune modulating nutrients without β-glucan in critically ill patients.

Detailed Description
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To determine whether high-protein (24% of total calorie from protein) enteral nutrition of immune modulating nutrients (eg, ω-3 fatty acids and antioxidants) enriched with β-glucan stimulates immune functions compared with standard enteral nutrition (control: 20% of total calorie from protein) or high-protein (24% of total calorie from protein) enteral nutrition of immune modulating nutrients without β-glucan in critically ill patients. In a randomized double-blind placebo-controlled study, 30 patients consumed 1 of 3 enteral nutrition: control, enteral nutrition of immune modulating nutrients enriched with β-glucan (250mg/L) or enteral nutrition of immune modulating nutrients without β-glucan. Enteral nutrition was initiated within 24 hours of ICU admission and continued during the ICU stay for a 7 days.

Official Title
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Effects of Enteral Formula Including Immune-modulating Nutrients on Clinical Course and Immune Function in Critically Ill Patients

Conditions
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Critical Illness

Intervention / Treatment
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* Dietary Supplement: standard enteral nutrition
* Dietary Supplement: high-protein enteral nutrition of immune modulating nutrients enriched with β-glucan
* Dietary Supplement: high-protein enteral nutrition of immune modulating nutrients without β-glucan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ICU patients Exclusion Criteria: ICU patients who could not receiving enteral nutrition
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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control group<br>standard enteral nutrition | Dietary Supplement: standard enteral nutrition<br>* standard enteral nutrition<br>* Other names: control group;|
| Experimental: test group I<br>high-protein enteral nutrition of immune modulating nutrients enriched with β-glucan | Dietary Supplement: high-protein enteral nutrition of immune modulating nutrients enriched with β-glucan<br>* high-protein enteral nutrition of immune modulating nutrients enriched with β-glucan<br>* Other names: test group I;|
| Experimental: test group II<br>high-protein enteral nutrition of immune modulating nutrients without β-glucan | Dietary Supplement: high-protein enteral nutrition of immune modulating nutrients without β-glucan<br>* high-protein enteral nutrition of immune modulating nutrients without β-glucan<br>* Other names: test group II;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline NK cell activity at 7 days | NK cell activity (%) | at baseline and 7 days follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline IL-12 at 7 days | IL-12 (pg/mL) | at baseline and 7 days follow-up | 
| Change from baseline hs-CRP at 7 days | hs-CRP (mg/dL) | at baseline and 7 days follow-up |