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

NCT ID: NCT02468713

Last Updated: 2015-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-04-30

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Group 1

Combiflex® lipid peri as a reference product (Period 1) -\> Winuf® peri as a test product (Period 2)

Group Type: EXPERIMENTAL

Combiflex® lipid peri

Intervention Type: DRUG

total parenteral nutrition solutions containing glucose, amino acids, electrolyte, soybean oil

Winuf® peri

Intervention Type: DRUG

total parenteral nutrition solution containing glucose, amino acids, electrolyte, soybean oil, medium chain triglyceride, olive oil and fish oil

Group 2

Winuf® peri as a test product (Period 1) -\> Combiflex® lipid peri as a reference product (Period 2)

Group Type: EXPERIMENTAL

Combiflex® lipid peri

Intervention Type: DRUG

total parenteral nutrition solutions containing glucose, amino acids, electrolyte, soybean oil

Winuf® peri

Intervention Type: DRUG

total parenteral nutrition solution containing glucose, amino acids, electrolyte, soybean oil, medium chain triglyceride, olive oil and fish oil

Interventions

Combiflex® lipid peri

total parenteral nutrition solutions containing glucose, amino acids, electrolyte, soybean oil

Intervention Type: DRUG

Winuf® peri

total parenteral nutrition solution containing glucose, amino acids, electrolyte, soybean oil, medium chain triglyceride, olive oil and fish oil

Intervention Type: DRUG

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

JW Pharmaceutical

INDUSTRY

Sponsor Role: collaborator

Chonbuk National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hee Chul Yu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hee Chul Yu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Countries

South Korea

Other Identifiers

CUH201412002

Identifier Type: -

Identifier Source: org_study_id