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

Yonsei University

Status: Completed

Conditions: Enteral Nutrition

Treatments: Dietary Supplement: soybean oil; Dietary Supplement: vegetable (canola, flaxseed) derived n-3 fatty acid

Study type: Interventional

Funder types: Other

Identifiers

NCT03638661

YS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 94 patients

Sex: All

Ages: 19 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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94 participants in 2 patient groups, including a placebo group

n-3 fatty acid enriched formula

Experimental group

Description:

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

Treatment:

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

soybean oil used formula

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: soybean oil