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
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- To compare Cmax of plasma triglyceride between Winuf peri and Combiflex lipid peri
Study Overview
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.
Detailed Description
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. The 16 subjects will be randomly assigned to 1 of 2 sequences of the two treatments: Combiflex® lipid peri or Winuf® peri will be infused via peripheral venous catheter for 6 hours at 3 ml/kg/h. Blood samples will be collected every 1 hour from 0 to 12 hours after starting an intravenous infusion for triglyceride, glucose, and insulin. Cholesterol, HDL-cholesterol, LDL-cholesterol, AST, ALT, and total bilirubin as liver function biomarkers, and hsCRP as inflammatory biomarker will be analysed at 0, 6 and 12 hour after starting an intravenous infusion.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 55 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Arms & Interventions
Group 1
Combiflex® lipid peri as a reference product (Period 1) -> Winuf® peri as a test product (Period 2)
Intervention: Combiflex® lipid peri (Drug)
Group 1
Combiflex® lipid peri as a reference product (Period 1) -> Winuf® peri as a test product (Period 2)
Intervention: Winuf® peri (Drug)
Group 2
Winuf® peri as a test product (Period 1) -> Combiflex® lipid peri as a reference product (Period 2)
Intervention: Combiflex® lipid peri (Drug)
Group 2
Winuf® peri as a test product (Period 1) -> Combiflex® lipid peri as a reference product (Period 2)
Intervention: Winuf® peri (Drug)
Outcomes
Primary Outcomes
To compare Cmax of plasma triglyceride between Winuf peri and Combiflex lipid peri
Time Frame: Before-dosing(0 hour) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing
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.
To compare AUC of plasma triglyceride between Winuf peri and Combiflex lipid peri
Time Frame: Before-dosing(0 hour) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing
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.
Secondary Outcomes
- 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 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)
- Change from baseline in blood ALT level at 6 and 12 hours(Before-dosing(0 hour) and 6, and 12 hours)
- 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 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)
- Change from baseline in blood HDL-cholesterol level at 6 and 12 hours(Before-dosing(0 hour) and 6, and 12 hours)
- Change from baseline in blood LDL-cholesterol level at 6 and 12 hours(Before-dosing(0 hour) and 6, and 12 hours)
- Change from baseline in blood AST level at 6 and 12 hours(Before-dosing(0 hour) and 6, and 12 hours)
- Change from baseline in blood hsCRP level at 6 and 12 hours(Before-dosing(0 hour) and 6, and 12 hours)
- Change from baseline in blood cholesterol level at 6 and 12 hours(Before-dosing(0 hour) and 6, and 12 hours)
- Change from baseline in blood total bilirubin level at 6 and 12 hours(Before-dosing(0 hour) and 6, and 12 hours)
- 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)
Investigators
Hee Chul Yu
Professor
Chonbuk National University Hospital