Effect of Immune-enhancing Enteral Nutrition on Immunomodulation in Critically Ill Patients
Effects of Enteral Formula Including Immune-modulating Nutrients on Clinical Course and Immune Function in Critically Ill Patients
1 other identifier
interventional
30
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2014
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 24, 2015
CompletedFirst Posted
Study publicly available on registry
October 6, 2015
CompletedOctober 6, 2015
October 1, 2015
1.4 years
September 24, 2015
October 5, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline NK cell activity at 7 days
NK cell activity (%)
at baseline and 7 days follow-up
Secondary Outcomes (2)
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
Study Arms (3)
control group
PLACEBO COMPARATORstandard enteral nutrition
test group I
EXPERIMENTALhigh-protein enteral nutrition of immune modulating nutrients enriched with β-glucan
test group II
EXPERIMENTALhigh-protein enteral nutrition of immune modulating nutrients without β-glucan
Interventions
standard enteral nutrition
high-protein enteral nutrition of immune modulating nutrients enriched with β-glucan
high-protein enteral nutrition of immune modulating nutrients without β-glucan
Eligibility Criteria
You may qualify if:
- ICU patients
You may not qualify if:
- ICU patients who could not receiving enteral nutrition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Lee JG, Kim YS, Lee YJ, Ahn HY, Kim M, Kim M, Cho MJ, Cho Y, Lee JH. Effect of Immune-Enhancing Enteral Nutrition Enriched with or without Beta-Glucan on Immunomodulation in Critically Ill Patients. Nutrients. 2016 Jun 2;8(6):336. doi: 10.3390/nu8060336.
PMID: 27271657DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jong Ho Lee, Ph. D.
Dept. of Food and Nutrition, College of Human Ecology, Yonsei University, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-749, South Korea
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2015
First Posted
October 6, 2015
Study Start
April 1, 2014
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
October 6, 2015
Record last verified: 2015-10