MedTrace Logo

Effect on Blood Chemistry and Inflammatory Marker of Omega-3 Enriched Total Parenteral Nutrition

NCT02468713 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2015-06-11

No results posted yet for this study

Summary

Fish oil is a rich source of omega-3 fatty acids, especially eicosapentanoic acid and docosahexaenoic acid, and it is not used widely in parenteral nutrition because fish oil emulsions have not been commercially available until very recently. The Objective of this study is to to evaluate the effect on blood lipid profiles of omega-3 enriched total parenteral nutrition in healthy Korean male subjects. This study is designed as a randomized, open-label, 2-treatment, 2-way crossover trial. Blood samples will be collected every 1 hour from 0 to 12 hours after starting an intravenous infusion for triglyceride, glucose, and insulin.

Conditions

  • Healthy

Interventions

DRUG

Combiflex® lipid peri

total parenteral nutrition solutions containing glucose, amino acids, electrolyte, soybean oil

DRUG

Winuf® peri

total parenteral nutrition solution containing glucose, amino acids, electrolyte, soybean oil, medium chain triglyceride, olive oil and fish oil

Sponsors & Collaborators

  • JW Pharmaceutical

    collaborator INDUSTRY

  • Chonbuk National University Hospital

    lead OTHER

Principal Investigators

  • Hee Chul Yu, MD, PhD · Professor

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02468713 on ClinicalTrials.gov