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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Chonbuk National University Hospital · Academic / Other
• Sex: Male
• Age: 30 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Combiflex® lipid peri	total parenteral nutrition solutions containing glucose, amino acids, electrolyte, soybean oil
DRUG	Winuf® peri	total parenteral nutrition solution containing glucose, amino acids, electrolyte, soybean oil, medium chain triglyceride, olive oil and fish oil

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2015-06-11
• Last updated: 2015-06-11

Locations

1 site across 1 country: South Korea