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

October 5, 2015 updated by: Yonsei University

Effects of Enteral Formula Including Immune-modulating Nutrients on Clinical Course and Immune Function 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ICU patients

Exclusion Criteria:

  • ICU patients who could not receiving enteral nutrition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: control group
standard enteral nutrition
Dietary supplement: standard enteral nutrition
standard enteral nutrition
Other Names:
  • control group
Experimental: test group I
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
high-protein enteral nutrition of immune modulating nutrients enriched with β-glucan
Other Names:
  • test group I
Experimental: test group II
high-protein enteral nutrition of immune modulating nutrients without β-glucan
Dietary supplement: high-protein enteral nutrition of immune modulating nutrients without β-glucan
high-protein enteral nutrition of immune modulating nutrients without β-glucan
Other Names:
  • test group II

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline IL-12 at 7 days
Time Frame: at baseline and 7 days follow-up
IL-12 (pg/mL)
at baseline and 7 days follow-up
Change from baseline hs-CRP at 7 days
Time Frame: at baseline and 7 days follow-up
hs-CRP (mg/dL)
at baseline and 7 days follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

September 24, 2015

First Submitted That Met QC Criteria

October 5, 2015

First Posted (Estimate)

October 6, 2015

Study Record Updates

Last Update Posted (Estimate)

October 6, 2015

Last Update Submitted That Met QC Criteria

October 5, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BT_ICU_immune

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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