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OpenTrials
Completed

NCT Number: NCT02569203

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

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.

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Key information

Conditions

Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ICU patients

Exclusion criteria

  • ICU patients who could not receiving enteral nutrition

Treatment and study plan

Standard enteral nutrition

Dietary Supplement

standard enteral nutrition

Other names: control group

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

Dietary Supplement

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

Other names: test group I

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

Dietary Supplement

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

Other names: test group II

Primary outcomes

  1. Change from baseline NK cell activity at 7 days

    Time frame: at baseline and 7 days follow-up

    NK cell activity (%)

Secondary outcomes

  1. Change from baseline IL-12 at 7 days

    Time frame: at baseline and 7 days follow-up

    IL-12 (pg/mL)

  2. Change from baseline hs-CRP at 7 days

    Time frame: at baseline and 7 days follow-up

    hs-CRP (mg/dL)

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 6, 2015
Registry last updated
Oct 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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