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

Not Applicable

Completed

• Conditions: Enteral Nutrition
• Interventions: Dietary Supplement: vegetable (canola, flaxseed) derived n-3 fatty acid; Dietary Supplement: soybean oil

• Registration Number: NCT03638661
• Lead Sponsor: Yonsei University

Brief Summary

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

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 Timeline

• Study Start: 2015-08-11
• Primary Completion: 2018-06-30
• Study Completion: 2018-07-30
• Status Verified: 2018-08
• Study First Submitted: 2018-08-06
• Study First Submitted QC: 2018-08-16
• Last Update Submitted: 2018-08-16
• Study First Posted: 2018-08-20
• Last Update Posted: 2018-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
n-3 fatty acid enriched formula	vegetable (canola, flaxseed) derived n-3 fatty acid	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
soybean oil used formula	soybean oil	Patients assigned to the control group received a soybean used formula by tube feeding. soybean used formula

Primary Outcome Measures

Name	Time	Method
NK cell activity	Baseline	NK cell activity (%)

Secondary Outcome Measures

Name	Time	Method
cytokine values	Baseline	(IL-12, IFN-γ, IL-1β , IL-6 and TNF-α)