Effect on Blood Chemistry and Inflammatory Marker of Omega-3 Enriched Total Parenteral Nutrition
An Open Label, Randomized, Single Dose, Crossover Study to Evaluate the Effect on Blood Lipid Profiles of Omega-3 Enriched Total Parenteral Nutrition in Healthy Korean Male Subjects
1 other identifier
interventional
16
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 healthy
Started Jan 2015
Shorter than P25 for phase_4 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 29, 2015
CompletedFirst Posted
Study publicly available on registry
June 11, 2015
CompletedJune 11, 2015
June 1, 2015
3 months
May 29, 2015
June 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To compare AUC of plasma triglyceride between Winuf peri and Combiflex lipid peri
The wash-out period will be 7 days, and the second study period will be conducted on the same schedule as the first study period, with the exception of the assignment of the investigational product.
Before-dosing(0 hour) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing
To compare Cmax of plasma triglyceride between Winuf peri and Combiflex lipid peri
The wash-out period will be 7 days, and the second study period will be conducted on the same schedule as the first study period, with the exception of the assignment of the investigational product.
Before-dosing(0 hour) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing
Secondary Outcomes (13)
To compare AUC of plasma glucose between Winuf peri and Combiflex lipid peri
Before-dosing(0 hour) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing
To compare Cmax of plasma glucose between Winuf peri and Combiflex lipid peri
Before-dosing(0 hour) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing
To compare AUC of plasma insulin between Winuf peri and Combiflex lipid peri
Before-dosing(0 hour) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing
To compare Cmax of plasma insulin between Winuf peri and Combiflex lipid peri
Before-dosing(0 hour) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing
To compare AUC of plasma omega-3 between Winuf peri and Combiflex lipid peri
Before-dosing(0 hour) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing
- +8 more secondary outcomes
Study Arms (2)
Group 1
EXPERIMENTALCombiflex® lipid peri as a reference product (Period 1) -\> Winuf® peri as a test product (Period 2)
Group 2
EXPERIMENTALWinuf® peri as a test product (Period 1) -\> Combiflex® lipid peri as a reference product (Period 2)
Interventions
total parenteral nutrition solutions containing glucose, amino acids, electrolyte, soybean oil
total parenteral nutrition solution containing glucose, amino acids, electrolyte, soybean oil, medium chain triglyceride, olive oil and fish oil
Eligibility Criteria
You may qualify if:
- Healthy male subjects between the ages of 30 and 55 years
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>45 kg
- An informed consent document signed and dated by the subject
- Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
You may not qualify if:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
- Screening sitting blood pressure \>150 mm Hg (systolic) or \>90 mm Hg (diastolic)
- Use of tobacco in excess of the equivalent of 20 cigarettes per day
- Use of prescription or nonprescription drugs within 10 days
- Blood donation within 2 months prior to dosing, or plasma donation within 1 month prior to dosing
- Severe hyperlipidemic patients
- Severe liver failure patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chonbuk National University Hospitallead
- JW Pharmaceuticalcollaborator
Study Sites (1)
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 561712, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hee Chul Yu, MD, PhD
Professor
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 29, 2015
First Posted
June 11, 2015
Study Start
January 1, 2015
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
June 11, 2015
Record last verified: 2015-06