Skip to main content
OpenTrials
Completed

NCT Number: NCT03638661

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Enteral Nutrition

Age range

19 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Dietary Supplement

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

Soybean Oil

Dietary Supplement

soybean oil used formula

Primary outcomes

  1. NK cell activity

    Time frame: Baseline

    NK cell activity (%)

Secondary outcomes

  1. cytokine values

    Time frame: Baseline

    (IL-12, IFN-γ, IL-1β , IL-6 and TNF-α)

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study 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

Acronym: YS

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Aug 20, 2018
Registry last updated
Aug 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.