Effects of Enteral Formula Including Immune-modulating Nutrients on Clinical Course and Immune Function in Critically Ill Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Yonsei University
- Enrollment
- 30
- Primary Endpoint
- Change from baseline NK cell activity at 7 days
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •ICU patients
Exclusion Criteria
- •ICU patients who could not receiving enteral nutrition
Outcomes
Primary Outcomes
Change from baseline NK cell activity at 7 days
Time Frame: at baseline and 7 days follow-up
NK cell activity (%)
Secondary Outcomes
- Change from baseline IL-12 at 7 days(at baseline and 7 days follow-up)
- Change from baseline hs-CRP at 7 days(at baseline and 7 days follow-up)