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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02569203
• Other study ID #: BT_ICU_immune
• Status: Completed
• Phase: N/A
• First received: September 24, 2015
• Last updated: October 5, 2015
• Start date: April 2014
• Est. completion date: September 2015

Study information

• Verified date: October 2015
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• ICU patients

Exclusion Criteria:

• ICU patients who could not receiving enteral nutrition

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Critical Illness

Intervention

Dietary Supplement:
• standard enteral nutrition
standard enteral nutrition
• high-protein enteral nutrition of immune modulating nutrients enriched with ß-glucan
high-protein enteral nutrition of immune modulating nutrients enriched with ß-glucan
• high-protein enteral nutrition of immune modulating nutrients without ß-glucan
high-protein enteral nutrition of immune modulating nutrients without ß-glucan

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline NK cell activity at 7 days	NK cell activity (%)	at baseline and 7 days follow-up	Yes
Secondary	Change from baseline IL-12 at 7 days	IL-12 (pg/mL)	at baseline and 7 days follow-up	Yes
Secondary	Change from baseline hs-CRP at 7 days	hs-CRP (mg/dL)	at baseline and 7 days follow-up	Yes