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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02569203

Enrollment

Registered

2015-10-06

Start date

2014-04-30

Completion date

2015-09-30

Last updated

2015-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTstandard enteral nutrition

standard enteral nutrition

DIETARY_SUPPLEMENThigh-protein enteral nutrition of immune modulating nutrients enriched with β-glucan

high-protein enteral nutrition of immune modulating nutrients enriched with β-glucan

DIETARY_SUPPLEMENThigh-protein enteral nutrition of immune modulating nutrients without β-glucan

high-protein enteral nutrition of immune modulating nutrients without β-glucan

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* ICU patients

Exclusion criteria

* ICU patients who could not receiving enteral nutrition

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026