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

Enteral Nutrition Clinical Trial

— YS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03638661
• Other study ID #: YS
• Status: Completed
• Phase: N/A
• Start date: August 11, 2015
• Est. completion date: July 30, 2018

Study information

• Verified date: August 2018
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: July 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Enteral Nutrition

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NK cell activity	NK cell activity (%)	Baseline
Secondary	cytokine values	(IL-12, IFN-?, IL-1ß , IL-6 and TNF-a)	Baseline