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

Chonbuk National University

Status and phase: Completed; Phase 4

Conditions: Healthy

Treatments: Drug: Winuf® peri; Drug: Combiflex® lipid peri

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02468713

CUH201412002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: Male

Ages: 30 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Group 1

Experimental group

Description:

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

Treatment:

Drug: Winuf® peri

Drug: Combiflex® lipid peri

Group 2

Experimental group

Description:

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

Treatment:

Drug: Winuf® peri

Drug: Combiflex® lipid peri