- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02468713
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Jeonbuk
-
Jeonju, Jeonbuk, Korea, Republic of, 561712
- Chonbuk National University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1
Combiflex® lipid peri as a reference product (Period 1) -> Winuf® peri as a test product (Period 2)
|
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
|
Experimental: Group 2
Winuf® peri as a test product (Period 1) -> Combiflex® lipid peri as a reference product (Period 2)
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
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.
|
Before-dosing(0 hour) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To compare AUC of plasma glucose 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
|
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
Time Frame: Before-dosing(0 hour) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing
|
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
Time Frame: Before-dosing(0 hour) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing
|
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
Time Frame: Before-dosing(0 hour) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing
|
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
Time Frame: Before-dosing(0 hour) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing
|
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
Time Frame: Before-dosing(0 hour) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing
|
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 cholesterol level at 6 and 12 hours
Time Frame: Before-dosing(0 hour) and 6, and 12 hours
|
Before-dosing(0 hour) and 6, and 12 hours
|
Change from baseline in blood HDL-cholesterol level at 6 and 12 hours
Time Frame: Before-dosing(0 hour) and 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
Time Frame: Before-dosing(0 hour) and 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
Time Frame: Before-dosing(0 hour) and 6, and 12 hours
|
Before-dosing(0 hour) and 6, and 12 hours
|
Change from baseline in blood ALT level at 6 and 12 hours
Time Frame: Before-dosing(0 hour) and 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
Time Frame: Before-dosing(0 hour) and 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
Time Frame: Before-dosing(0 hour) and 6, and 12 hours
|
Before-dosing(0 hour) and 6, and 12 hours
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Hee Chul Yu, MD, PhD, professor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CUH201412002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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