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

Study Overview
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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.

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

Conditions
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Enteral Nutrition

Intervention / Treatment
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* Dietary Supplement: vegetable (canola, flaxseed) derived n-3 fatty acid
* Dietary Supplement: soybean oil


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: n-3 fatty acid enriched formula<br>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<br>* vegetable (canola, flaxseed) derived n-3 fatty acid was used for fat source.<br>|
| Placebo Comparator: soybean oil used formula<br>Patients assigned to the control group received a soybean used formula by tube feeding. soybean used formula | Dietary Supplement: soybean oil<br>* soybean oil used formula<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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