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

NCT03638661 | Completed

• 1 other identifier: YS
• Study Type: interventional
• Target: 94
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Enteral Nutrition

Outcome Measures

Primary Outcomes (1)

• NK cell activity

  NK cell activity (%)

  Baseline

Secondary Outcomes (1)

• cytokine values

  Baseline

Study Arms (2)

n-3 fatty acid enriched formula

EXPERIMENTAL

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

soybean oil used formula

PLACEBO COMPARATOR

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

Dietary Supplement: soybean oil

Interventions

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

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

n-3 fatty acid enriched formula

soybean oil DIETARY_SUPPLEMENT

soybean oil used formula

soybean oil used formula

Eligibility Criteria

• Age: 19 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

MeSH Terms

Interventions

Vegetables; Linseed Oil; Soybean Oil

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Fats, Unsaturated; Fats; Lipids; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures; Dietary Fats, Unsaturated; Dietary Fats

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The ready-to-use soybean used formula and n3EN formula had identical packaging with no differences in appearance, texture, or smell.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Principal Investigator

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: August 20, 2018
• Study Start: August 11, 2015
• Primary Completion: June 30, 2018
• Study Completion: July 30, 2018
• Last Updated: August 20, 2018

Record last verified: 2018-08