n-3 Fatty Acids in Enteral Formula on NK Cell Activity (YS)

August 16, 2018 updated by: Jong Ho Lee, Yonsei University

Effect of Immune-enhancing Enteral Nutrition Formula Enriched With Vegetable Derived n-3 Fatty Acids on NK Cell Activity in Hospitalized Patients for Rehabilitation

The aim of our study was to investigate the NK cell activity alternations and related cytokine changes in comparison with soybean oil used formula (control) and the canola and flaxseed oil used n-3 fatty acid enriched formula (n3EN, test) with non-surgical hospitalized patients for rehabilitation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients were randomized to receive one of two types of enteral nutrition formula: soybean oil used enteral nutrition (control), vegetable (canola, flaxseed) derived n-3 fatty acid enriched enteral nutrition (n3EN). Blood samples were collected on the first day and 14 days after consumption of each formula and anthropometric parameters were collected. Hematology and biochemical values were analyzed and NK cell activities and serum cytokine productions were measured.

Study Type

Interventional

Enrollment (Actual)

94

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

19 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who were admitted to the Severance Hospital Rehabilitation Department , enteral tube feeding patient, Adult male and female patients aged 19 years and over, Patients who signed the consent form

Exclusion Criteria:

  • Patient with nausea
  • Patients with hepatic impairment (total bilirubin concentration> 3.5 mg / dl)
  • Patients with renal impairment (serum creatinine concentration> 3 mg / dl or requiring peritoneal or hemodialysis) diabetic patients
  • Patients who are undergoing chemotherapy or who are within 1 month of the end of chemotherapy
  • Patients whose life expectancy is less than 1 month
  • Pregnant women and women who are pregnant

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: n-3 fatty acid enriched formula

Those assigned to the n3EN group received vegetable n-3 fatty acid enriched formula by tube feeding (product; Yonsei Dairy Co., Seoul, South Korea).

vegetable (canola, flaxseed) derived n-3 fatty acid
Dietary supplement: vegetable (canola, flaxseed) derived n-3 fatty acid
vegetable (canola, flaxseed) derived n-3 fatty acid was used for fat source.
PLACEBO_COMPARATOR: soybean oil used formula

Patients assigned to the control group received a soybean used formula by tube feeding.

soybean used formula
Dietary supplement: soybean oil
soybean oil used formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NK cell activity
Time Frame: Baseline
NK cell activity (%)
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cytokine values
Time Frame: Baseline
(IL-12, IFN-γ, IL-1β , IL-6 and TNF-α)
Baseline

Collaborators and Investigators

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

Sponsor

Yonsei University

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 (ACTUAL)

August 11, 2015

Primary Completion (ACTUAL)

June 30, 2018

Study Completion (ACTUAL)

July 30, 2018

Study Registration Dates

First Submitted

August 6, 2018

First Submitted That Met QC Criteria

August 16, 2018

First Posted (ACTUAL)

August 20, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 20, 2018

Last Update Submitted That Met QC Criteria

August 16, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • YS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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