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

Not Applicable

Completed

• Conditions: Critical Illness
• Interventions: 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; Dietary Supplement: standard enteral nutrition

• Registration Number: NCT02569203
• Lead Sponsor: Yonsei University

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-04
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Study First Submitted: 2015-09-24
• Status Verified: 2015-10
• Study First Submitted QC: 2015-10-05
• Last Update Submitted: 2015-10-05
• Study First Posted: 2015-10-06
• Last Update Posted: 2015-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• ICU patients

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Exclusion Criteria

• ICU patients who could not receiving enteral nutrition

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
test group I	high-protein enteral nutrition of immune modulating nutrients enriched with β-glucan	high-protein enteral nutrition of immune modulating nutrients enriched with β-glucan
test group II	high-protein enteral nutrition of immune modulating nutrients without β-glucan	high-protein enteral nutrition of immune modulating nutrients without β-glucan
control group	standard enteral nutrition	standard enteral nutrition

Primary Outcome Measures

Name	Time	Method
Change from baseline NK cell activity at 7 days	at baseline and 7 days follow-up	NK cell activity (%)

Secondary Outcome Measures

Name	Time	Method
Change from baseline IL-12 at 7 days	at baseline and 7 days follow-up	IL-12 (pg/mL)
Change from baseline hs-CRP at 7 days	at baseline and 7 days follow-up	hs-CRP (mg/dL)