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

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ClinicalTrials.gov Identifier: NCT02468713
Recruitment Status : Completed
First Posted : June 11, 2015
Last Update Posted : June 11, 2015
Sponsor:
Collaborator:
JW Pharmaceutical
Information provided by (Responsible Party):
Hee Chul Yu, Chonbuk National University Hospital

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Combiflex® lipid peri Drug: Winuf® peri Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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 Start Date : January 2015
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1
Combiflex® lipid peri as a reference product (Period 1) -> Winuf® peri as a test product (Period 2)
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

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




Primary Outcome Measures :
  1. To compare AUC of plasma triglyceride between Winuf peri and Combiflex lipid peri [ Time Frame: Before-dosing(0 hour) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing ]
    The wash-out period will be 7 days, and the second study period will be conducted on the same schedule as the first study period, with the exception of the assignment of the investigational product.

  2. To compare Cmax of plasma triglyceride between Winuf peri and Combiflex lipid peri [ Time Frame: Before-dosing(0 hour) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing ]
    The wash-out period will be 7 days, and the second study period will be conducted on the same schedule as the first study period, with the exception of the assignment of the investigational product.


Secondary Outcome Measures :
  1. To compare AUC of plasma glucose between Winuf peri and Combiflex lipid peri [ Time Frame: Before-dosing(0 hour) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing ]
  2. To compare Cmax of plasma glucose between Winuf peri and Combiflex lipid peri [ Time Frame: Before-dosing(0 hour) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing ]
  3. To compare AUC of plasma insulin between Winuf peri and Combiflex lipid peri [ Time Frame: Before-dosing(0 hour) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing ]
  4. To compare Cmax of plasma insulin between Winuf peri and Combiflex lipid peri [ Time Frame: Before-dosing(0 hour) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing ]
  5. To compare AUC of plasma omega-3 between Winuf peri and Combiflex lipid peri [ Time Frame: Before-dosing(0 hour) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing ]
  6. To compare Cmax of plasma omega-3 between Winuf peri and Combiflex lipid peri [ Time Frame: Before-dosing(0 hour) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing ]
  7. Change from baseline in blood cholesterol level at 6 and 12 hours [ Time Frame: Before-dosing(0 hour) and 6, and 12 hours ]
  8. Change from baseline in blood HDL-cholesterol level at 6 and 12 hours [ Time Frame: Before-dosing(0 hour) and 6, and 12 hours ]
  9. Change from baseline in blood LDL-cholesterol level at 6 and 12 hours [ Time Frame: Before-dosing(0 hour) and 6, and 12 hours ]
  10. Change from baseline in blood AST level at 6 and 12 hours [ Time Frame: Before-dosing(0 hour) and 6, and 12 hours ]
  11. Change from baseline in blood ALT level at 6 and 12 hours [ Time Frame: Before-dosing(0 hour) and 6, and 12 hours ]
  12. Change from baseline in blood total bilirubin level at 6 and 12 hours [ Time Frame: Before-dosing(0 hour) and 6, and 12 hours ]
  13. Change from baseline in blood hsCRP level at 6 and 12 hours [ Time Frame: Before-dosing(0 hour) and 6, and 12 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02468713


Locations
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Korea, Republic of
Chonbuk National University Hospital
Jeonju, Jeonbuk, Korea, Republic of, 561712
Sponsors and Collaborators
Chonbuk National University Hospital
JW Pharmaceutical
Investigators
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Principal Investigator: Hee Chul Yu, MD, PhD Professor

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Responsible Party: Hee Chul Yu, Professor, Chonbuk National University Hospital
ClinicalTrials.gov Identifier: NCT02468713     History of Changes
Other Study ID Numbers: CUH201412002
First Posted: June 11, 2015    Key Record Dates
Last Update Posted: June 11, 2015
Last Verified: June 2015

Keywords provided by Hee Chul Yu, Chonbuk National University Hospital:
Omega-3
Blood lipid profiles
DHA
EPA
Triglyceride
Glucose
Insulin
LDL
TPN

Additional relevant MeSH terms:
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Parenteral Nutrition Solutions
Pharmaceutical Solutions