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

NCT ID: NCT03638661

Last Updated: 2018-08-20

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-11

Study Completion Date

2018-07-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Enteral Nutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
The ready-to-use soybean used formula and n3EN formula had identical packaging with no differences in appearance, texture, or smell.

Study Groups

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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

Group Type EXPERIMENTAL

vegetable (canola, flaxseed) derived n-3 fatty acid

Intervention Type DIETARY_SUPPLEMENT

vegetable (canola, flaxseed) derived n-3 fatty acid was used for fat source.

soybean oil used formula

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

soybean used formula

Group Type PLACEBO_COMPARATOR

soybean oil

Intervention Type DIETARY_SUPPLEMENT

soybean oil used formula

Interventions

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vegetable (canola, flaxseed) derived n-3 fatty acid

vegetable (canola, flaxseed) derived n-3 fatty acid was used for fat source.

Intervention Type DIETARY_SUPPLEMENT

soybean oil

soybean oil used formula

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Jong Ho Lee

Professor, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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YS

Identifier Type: -

Identifier Source: org_study_id

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