HealthyPhase 4NCT02468713
Effect on Blood Chemistry and Inflammatory Marker of Omega-3 Enriched Total Parenteral Nutrition
A Phase 4 study testing Combiflex® lipid peri and Winuf® peri in people with Healthy, run by Chonbuk National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Combiflex® lipid peri and Winuf® peri
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2015to Apr 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
South Korea1 site
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 561712
About this study
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
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.
Read the 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
- Being tested
- Combiflex® lipid peri, Winuf® peri
- Keywords
- Omega-3, Blood lipid profiles, DHA, EPA, Triglyceride, Glucose, Insulin, LDL, TPN
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combiflex® lipid periDrug
total parenteral nutrition solutions containing glucose, amino acids, electrolyte, soybean oil
Winuf® periDrug
total parenteral nutrition solution containing glucose, amino acids, electrolyte, soybean oil, medium chain triglyceride, olive oil and fish oil
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Combiflex® lipid peri as a reference product (Period 1) -> Winuf® peri as a test product (Period 2) Receives: Drug: Combiflex® lipid peri; Drug: Winuf® peri |
| Group 2 | Experimental | Winuf® peri as a test product (Period 1) -> Combiflex® lipid peri as a reference product (Period 2) Receives: Drug: Combiflex® lipid peri; Drug: Winuf® peri |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare AUC of plasma triglyceride between Winuf peri and Combiflex lipid peri
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.
Measured: Before-dosing(0 hour) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing
To compare Cmax of plasma triglyceride between Winuf peri and Combiflex lipid peri
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.
Measured: Before-dosing(0 hour) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing
Secondary outcomes (13)
To compare AUC of plasma glucose between Winuf peri and Combiflex lipid peri
Measured: Before-dosing(0 hour) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing
To compare Cmax of plasma glucose between Winuf peri and Combiflex lipid peri
Measured: Before-dosing(0 hour) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing
To compare AUC of plasma insulin between Winuf peri and Combiflex lipid peri
Measured: Before-dosing(0 hour) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing
To compare Cmax of plasma insulin between Winuf peri and Combiflex lipid peri
Measured: Before-dosing(0 hour) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing
To compare AUC of plasma omega-3 between Winuf peri and Combiflex lipid peri
Measured: Before-dosing(0 hour) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing
To compare Cmax of plasma omega-3 between Winuf peri and Combiflex lipid peri
Measured: Before-dosing(0 hour) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing
Change from baseline in blood cholesterol level at 6 and 12 hours
Measured: Before-dosing(0 hour) and 6, and 12 hours
Change from baseline in blood HDL-cholesterol level at 6 and 12 hours
Measured: Before-dosing(0 hour) and 6, and 12 hours
Change from baseline in blood LDL-cholesterol level at 6 and 12 hours
Measured: Before-dosing(0 hour) and 6, and 12 hours
Change from baseline in blood AST level at 6 and 12 hours
Measured: Before-dosing(0 hour) and 6, and 12 hours
Change from baseline in blood ALT level at 6 and 12 hours
Measured: Before-dosing(0 hour) and 6, and 12 hours
Change from baseline in blood total bilirubin level at 6 and 12 hours
Measured: Before-dosing(0 hour) and 6, and 12 hours
Change from baseline in blood hsCRP level at 6 and 12 hours
Measured: Before-dosing(0 hour) and 6, and 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2015 (estimated)
- Study startJan 2015
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonbuk National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- JW Pharmaceutical
- Responsible party
- Principal investigator, Hee Chul Yu, Chonbuk National University Hospital
- Investigators
- Hee Chul Yu, MD, PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02468713
- Sponsor's protocol ID
- CUH201412002
- Status last verified
- Jun 2015
- First submitted
- 29 May 2015
- Last updated
- 11 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02468713
- Acronym / sponsor ID
- CUH201412002
- Conditions
- Healthy
- Keywords
- Omega-3, Blood lipid profiles, DHA, EPA, Triglyceride, Glucose, Insulin, LDL
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Collaborators
- JW Pharmaceutical
- Study start
- Jan 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 11 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Combiflex® lipid peri, Drug: Winuf® periCombiflex® lipid peri as a reference product (Period 1) -> Winuf® peri as a test product (Period 2) |
| Group 2 | Experimental | Drug: Combiflex® lipid peri, Drug: Winuf® periWinuf® peri as a test product (Period 1) -> Combiflex® lipid peri as a reference product (Period 2) |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combiflex® lipid peritotal parenteral nutrition solutions containing glucose, amino acids, electrolyte, soybean oil | Drug | Group 1, Group 2 |
| Winuf® peritotal parenteral nutrition solution containing glucose, amino acids, electrolyte, soybean oil, medium chain triglyceride, olive oil and fish oil | Drug | Group 1, Group 2 |
Primary outcome
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.
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.
13 secondary outcomes
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
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
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
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
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
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
Change from baseline in blood cholesterol level at 6 and 12 hours
Time frame: Before-dosing(0 hour) and 6, and 12 hours
Change from baseline in blood HDL-cholesterol level at 6 and 12 hours
Time frame: Before-dosing(0 hour) and 6, and 12 hours
Change from baseline in blood LDL-cholesterol level at 6 and 12 hours
Time frame: Before-dosing(0 hour) and 6, and 12 hours
Change from baseline in blood AST level at 6 and 12 hours
Time frame: Before-dosing(0 hour) and 6, and 12 hours
Change from baseline in blood ALT level at 6 and 12 hours
Time frame: Before-dosing(0 hour) and 6, and 12 hours
Change from baseline in blood total bilirubin level at 6 and 12 hours
Time frame: Before-dosing(0 hour) and 6, and 12 hours
Change from baseline in blood hsCRP level at 6 and 12 hours
Time frame: Before-dosing(0 hour) and 6, and 12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hee Chul Yu, MD, PhD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Combiflex® lipid peri and Winuf® peri in people with Healthy, run by Chonbuk National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2015.