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

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Chonbuk National University Hospital
• Collaborator: JW Pharmaceutical
• Treatments: Parenteral Nutrition Solutions

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