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

NCT ID: NCT02569203

Last Updated: 2015-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Critical Illness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

control group

standard enteral nutrition

Group Type PLACEBO_COMPARATOR

standard enteral nutrition

Intervention Type DIETARY_SUPPLEMENT

standard enteral nutrition

test group I

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

Group Type EXPERIMENTAL

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

Intervention Type DIETARY_SUPPLEMENT

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

test group II

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

Group Type EXPERIMENTAL

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

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

standard enteral nutrition

standard enteral nutrition

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

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

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

control group test group I test group II

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* ICU patients

Exclusion Criteria

* ICU patients who could not receiving enteral nutrition
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Yonsei University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jong Ho Lee, Ph. D.

Role: PRINCIPAL_INVESTIGATOR

Dept. of Food and Nutrition, College of Human Ecology, Yonsei University, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-749, South Korea

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 27271657 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BT_ICU_immune

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.