Clinical trial NCT02468713: Effect on Blood Chemistry and Inflammatory Marker of Omega-3 Enriched Total Parenteral Nutrition
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: Omega-3
Blood lipid profiles
DHA
EPA
Triglyceride
Glucose
Insulin
LDL
TPN
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
Collaborators: name: JW Pharmaceutical
First posted: 2015-06-11
Enrollment: 16
Sex: MALE
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: To compare AUC of plasma triglyceride between Winuf peri and Combiflex lipid peri
timeFrame: Before-dosing(0 hour) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing
measure: To compare Cmax of plasma triglyceride between Winuf peri and Combiflex lipid peri
timeFrame: Before-dosing(0 hour) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing
Secondary outcomes:
measure: To compare AUC of plasma glucose between Winuf peri and Combiflex lipid peri
timeFrame: Before-dosing(0 hour) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing
measure: To compare Cmax of plasma glucose between Winuf peri and Combiflex lipid peri
timeFrame: Before-dosing(0 hour) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing
measure: To compare AUC of plasma insulin between Winuf peri and Combiflex lipid peri
timeFrame: Before-dosing(0 hour) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing
measure: To compare Cmax of plasma insulin between Winuf peri and Combiflex lipid peri
timeFrame: Before-dosing(0 hour) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing
measure: To compare AUC of plasma omega-3 between Winuf peri and Combiflex lipid peri
timeFrame: Before-dosing(0 hour) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing
measure: To compare Cmax of plasma omega-3 between Winuf peri and Combiflex lipid peri
timeFrame: Before-dosing(0 hour) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing
measure: Change from baseline in blood cholesterol level at 6 and 12 hours
timeFrame: Before-dosing(0 hour) and 6, and 12 hours
measure: Change from baseline in blood HDL-cholesterol level at 6 and 12 hours
timeFrame: Before-dosing(0 hour) and 6, and 12 hours
measure: Change from baseline in blood LDL-cholesterol level at 6 and 12 hours
timeFrame: Before-dosing(0 hour) and 6, and 12 hours
measure: Change from baseline in blood AST level at 6 and 12 hours
timeFrame: Before-dosing(0 hour) and 6, and 12 hours
measure: Change from baseline in blood ALT level at 6 and 12 hours
timeFrame: Before-dosing(0 hour) and 6, and 12 hours
measure: Change from baseline in blood total bilirubin level at 6 and 12 hours
timeFrame: Before-dosing(0 hour) and 6, and 12 hours
measure: Change from baseline in blood hsCRP level at 6 and 12 hours
timeFrame: Before-dosing(0 hour) and 6, and 12 hours
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
state: Jeonbuk
Study officials:
affiliation: Professor
name: Hee Chul Yu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: