HypertriglyceridemiaNCT01908374
Bioavailability of EPA and DHA From Two Dietary Supplements
A study testing DHA-rich fish oil versus Phospholipid-rich fish oil in people with Hypertriglyceridemia, run by Arctic Nutrition AS at 1 site in United States.
Trial summary
The primary objective of this study is to test the effects of two different fish oil products containing DHA and EPA by comparing the omega-3 fatty acid levels in the blood. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertriglyceridemia
- What is being tested?
- DHA-rich fish oil versus Phospholipid-rich fish oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Dec 2013
- Phase
- Interventional
- 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 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is male or female, 18-59 years of age, inclusive.
- Subject has a body mass index (BMI) of ≥18.50 and ≤29.99 kg/m2 at visit 1b (day -7).
- Subject has a score of 7 to 10 on the Vein Access Scale at visit 1b (day -7; Appendix 3).
- Subject has no health conditions that would prevent him/her from fulfilling the study requirements as judged by the Investigator on the basis of medical history and routine laboratory test results.
- Subject has a fasting TG 100-249 mg/dL at visit 1b (day -7). One venous retest allowed if ≥250 mg/dL.
- Subject is willing to refrain from consumption of all fish/seafood (including shellfish), foods rich in choline, fatty acid-containing foods and supplements, and/or EPA-, DHA-containing foods and supplements (≤1.0 g/d ) 14 d prior to visit 2 (day 0) and throughout the study (Appendix 1).
Show all 11Show fewer
- Subject is willing to limit alcohol consumption to no more than 1 drink/d following visit 1b (day -7) and throughout the study.
- Subject has no plans to change smoking habits during the study period and agrees to abstain from tobacco products for at least 1 h prior to and throughout the duration of the clinic visits [visits 1b, 3 and 5 (days -7, 14 and 56) for up to 2 h; and visits 2 and 4 (days 0 and 42) for up to 14 h].
- Subject is willing to comply with fecal collection procedures.
- Subject is willing to maintain habitual diet (with the exception of foods to be restricted), physical activity patterns, and body weight throughout the trial.
- Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.
Who cannot join
- Subject is male or female, 18-59 years of age, inclusive.
- Subject has a body mass index (BMI) of ≥18.50 and ≤29.99 kg/m2 at visit 1b (day -7).
- Subject has a score of 7 to 10 on the Vein Access Scale at visit 1b (day -7; Appendix 3).
- Subject has no health conditions that would prevent him/her from fulfilling the study requirements as judged by the Investigator on the basis of medical history and routine laboratory test results.
- Subject has a fasting TG 100-249 mg/dL at visit 1b (day -7). One venous retest allowed if ≥250 mg/dL.
- Subject is willing to refrain from consumption of all fish/seafood (including shellfish), foods rich in choline, fatty acid-containing foods and supplements, and/or EPA-, DHA-containing foods and supplements (≤1.0 g/d ) 14 d prior to visit 2 (day 0) and throughout the study (Appendix 1).
Show all 11Show fewer
- Subject is willing to limit alcohol consumption to no more than 1 drink/d following visit 1b (day -7) and throughout the study.
- Subject has no plans to change smoking habits during the study period and agrees to abstain from tobacco products for at least 1 h prior to and throughout the duration of the clinic visits [visits 1b, 3 and 5 (days -7, 14 and 56) for up to 2 h; and visits 2 and 4 (days 0 and 42) for up to 14 h].
- Subject is willing to comply with fecal collection procedures.
- Subject is willing to maintain habitual diet (with the exception of foods to be restricted), physical activity patterns, and body weight throughout the trial.
- Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Biofortis
Addison, Illinois, 60101
Kevin C Maki, Ph. D.
About this study
Official title: A Randomized, Controlled, Crossover Study to Evaluate the Acute and Subchronic Bioavailability of Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) From Two Dietary Supplements in Men and Women With Mildly Elevated Triglycerides
The primary objective of this study is to test the effects of two different fish oil products containing DHA and EPA by comparing the omega-3 fatty acid levels in the blood.
Read the detailed description
The objective of this study is to evaluate and compare the acute and sub-chronic (2 week) bioavailability of EPA and DHA from two marine oil supplements consumed with a meal in men and women with mildly elevated triglycerides. The supplements provide similar amounts of EPA + DHA esterified as either triglycerides; or esterified as phospholipids and triglycerides.
- Conditions
- Hypertriglyceridemia
- Being tested
- DHA-rich fish oil versus Phospholipid-rich fish oil
- Keywords
- Active-placebo controlled double blind cross over
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHA-rich fish oil versus Phospholipid-rich fish oilDietary supplement
Also called MOPL(TM)30, Marine Omega-3 Phospholipids, Herring Caviar Phospholipids
This randomized, controlled crossover study will include four treatment visits (visits 2, 3, 4, and 5; days 0, 14, 42, and 56). Subjects will be randomly assigned, by sex and age, to their first treatment study product (active or control), which will be administered with a standardized low-choline, DHA-, EPA- free breakfast meal at t = 0 h. Subjects will consume placebo or phospholipid-rich fish oil for two weeks, washed out for 4 weeks, then treatments switched. Blood samples will be obtained for acute measurements on visits 2 and 4, via an indwelling venous catheter or venipuncture at t = 1, 2, 4, 6, 8, 10, and 12 h ± 5 min, to determine plasma fatty acid profile. Chronic fatty acid measurements will be determined after 2 weeks on visits 3 and 5.
| Study group | Role | What they receive |
|---|---|---|
| DHA-rich fish oil | Active comparator | DHA-rich fish oil versus Phospholipid-rich fish oil Fish oil in triglyceride form (12 capsules/d providing 575 mg/d EPA; 1843 mg/d DHA; 259 mg/d n-3 DPA) Receives: Dietary Supplement: DHA-rich fish oil versus Phospholipid-rich fish oil |
| Phospholipid-rich fish oil | Experimental | DHA-rich fish oil versus Phospholipid-rich fish oil Fish roe high in EPA/DHA phospholipids [(12 capsules/d providing 628 mg/d EPA; 1810 mg/d DHA; 137 mg/d n-3 docosapentaenoic acid (DPA)] Receives: Dietary Supplement: DHA-rich fish oil versus Phospholipid-rich fish oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve for plasma phosphatidylcholine omega-3 fatty acids
The primary outcome variable will be the net incremental area under the curve (niAUC) for plasma phosphatidylcholine (PC) EPA + DHA from pre-meal (t = -0.5 h pre-dose) to 12 h post-dose (niAUC 0-12 h post-dose) measured at visits 2 and 4 (analyzed with and without normalization to the intake of EPA+DHA in each group).
Measured: pre-dose, 1, 2, 4, 6, 8, 10, 12 hours post-dose
Secondary outcomes (7)
Maximum concentration and Time to maximum concentration for plasma omega-3 phosphatidylcholine fatty acids
The maximal concentration (Cmax) and time to Cmax (Tmax) for plasma PC EPA + DHA, EPA, DHA, DPA, and EPA + DHA + DPA (analyzed with and without normalization to the intake of EPA, DHA, DPA, and EPA+DHA+DPA in each group) from pre-meal to 12 h post-dose at visits 2 and 4.
Measured: pre-dose, 1, 2, 4, 6, 8, 10, 12 hours post-dose
Area under the curve for plasma phosphatidylcholine omega-3 fatty acids Part 2
The niAUC for plasma PC EPA; PC DHA; PC DPA; PC EPA + DHA + DPA from pre-meal (t = -0.5 h pre-dose) to 12 h post-dose (niAUC0-12 h) at visits 2 and 4 (analyzed with and without normalization to the intake of EPA, DHA, DPA, and EPA+DHA+DPA in each group).
Measured: pre-dose, 1, 2, 4, 6, 8, 10, 12 hours post-dose
Plasma sphingomyelin and total plasma phosphatidylcholine
Plasma sphingomyelin and total plasma PC at visits 2, 3, 4, and 5
Measured: pre-dose, 0, 1, 2, 4, 6, 8, 10, 12 hours post-dose
Fasting plasma lipoprotein lipids
Percent changes from baseline (average of values at visits 1 and 2) to the end of each treatment period (visits 3,4,5) in the following fasting lipoprotein lipids: high-density lipoprotein cholesterol (HDL-C), non-HDL-C, low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), triglycerides, and high sensitivity C reactive protein (hs-CRP).
Measured: pre-dose
Gastrointestinal (GI) Tolerability Questionnaire
Ratings from the GI Tolerability Questionnaire
Measured: 0, 12 hours post-dose
Product Acceptability Questionnaire
Ratings from the Product Acceptability Questionnaire
Measured: 0, 12 hours post-dose
Adverse Events (AE)
AE assessed at each visit
Measured: pre-treatment, 0, 12 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for HypertriglyceridemiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arctic Nutrition AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioFortis, University of British Columbia
- Responsible party
- Sponsor
- Investigators
- Kevin C Maki, Ph. D, Study director, BioFortisKathleen Kelley, M.D., Principal investigator, BioFortis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01908374
- Sponsor's protocol ID
- PRV-1302
- Status last verified
- Jul 2013
- First submitted
- 19 Jul 2013
- Last updated
- 25 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Davidson MH, Maki KC, Bays H, Carter R, Ballantyne CM. Effects of prescription omega-3-acid ethyl esters on lipoprotein particle concentrations, apolipoproteins AI and CIII, and lipoprotein-associated phospholipase A(2) mass in statin-treated subjects with hypertriglyceridemia. J Clin Lipidol. 2009 Oct;3(5):332-40. doi: 10.1016/j.jacl.2009.08.001. Epub 2009 Aug 31.
PubMed 21291831Davidson MH, Johnson J, Rooney MW, Kyle ML, Kling DF. A novel omega-3 free fatty acid formulation has dramatically improved bioavailability during a low-fat diet compared with omega-3-acid ethyl esters: the ECLIPSE (Epanova((R)) compared to Lovaza((R)) in a pharmacokinetic single-dose evaluation) study. J Clin Lipidol. 2012 Nov-Dec;6(6):573-84. doi: 10.1016/j.jacl.2012.01.002. Epub 2012 Jan 24.
PubMed 23312053Grimsgaard S, Bonaa KH, Hansen JB, Nordoy A. Highly purified eicosapentaenoic acid and docosahexaenoic acid in humans have similar triacylglycerol-lowering effects but divergent effects on serum fatty acids. Am J Clin Nutr. 1997 Sep;66(3):649-59. doi: 10.1093/ajcn/66.3.649.
PubMed 9280188Maki KC, Reeves MS, Farmer M, Griinari M, Berge K, Vik H, Hubacher R, Rains TM. Krill oil supplementation increases plasma concentrations of eicosapentaenoic and docosahexaenoic acids in overweight and obese men and women. Nutr Res. 2009 Sep;29(9):609-15. doi: 10.1016/j.nutres.2009.09.004.
PubMed 19854375Miller M, Stone NJ, Ballantyne C, Bittner V, Criqui MH, Ginsberg HN, Goldberg AC, Howard WJ, Jacobson MS, Kris-Etherton PM, Lennie TA, Levi M, Mazzone T, Pennathur S; American Heart Association Clinical Lipidology, Thrombosis, and Prevention Committee of the Council on Nutrition, Physical Activity, and Metabolism; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular Nursing; Council on the Kidney in Cardiovascular Disease. Triglycerides and cardiovascular disease: a scientific statement from the American Heart Association. Circulation. 2011 May 24;123(20):2292-333. doi: 10.1161/CIR.0b013e3182160726. Epub 2011 Apr 18. No abstract available.
PubMed 21502576Mori TA, Burke V, Puddey IB, Watts GF, O'Neal DN, Best JD, Beilin LJ. Purified eicosapentaenoic and docosahexaenoic acids have differential effects on serum lipids and lipoproteins, LDL particle size, glucose, and insulin in mildly hyperlipidemic men. Am J Clin Nutr. 2000 May;71(5):1085-94. doi: 10.1093/ajcn/71.5.1085.
PubMed 10799369Schuchardt JP, Schneider I, Meyer H, Neubronner J, von Schacky C, Hahn A. Incorporation of EPA and DHA into plasma phospholipids in response to different omega-3 fatty acid formulations--a comparative bioavailability study of fish oil vs. krill oil. Lipids Health Dis. 2011 Aug 22;10:145. doi: 10.1186/1476-511X-10-145.
PubMed 21854650Ulven SM, Kirkhus B, Lamglait A, Basu S, Elind E, Haider T, Berge K, Vik H, Pedersen JI. Metabolic effects of krill oil are essentially similar to those of fish oil but at lower dose of EPA and DHA, in healthy volunteers. Lipids. 2011 Jan;46(1):37-46. doi: 10.1007/s11745-010-3490-4. Epub 2010 Nov 2.
PubMed 21042875
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Crossover Study to Evaluate the Acute and Subchronic Bioavailability of Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) From Two Dietary Supplements in Men and Women With Mildly Elevated Triglycerides
- ClinicalTrials.gov ID
- NCT01908374
- Acronym / sponsor ID
- PRV-1302
- Conditions
- Hypertriglyceridemia
- Keywords
- Active-placebo controlled double blind cross over
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Arctic Nutrition ASIndustry (pharma, biotech, devices)
- Collaborators
- BioFortis, University of British Columbia
- Study start
- Jul 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 25 Jul 2013 (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.
The primary objective of this study is to test the effects of two different fish oil products containing DHA and EPA by comparing the omega-3 fatty acid levels in the blood.
Detailed description
The objective of this study is to evaluate and compare the acute and sub-chronic (2 week) bioavailability of EPA and DHA from two marine oil supplements consumed with a meal in men and women with mildly elevated triglycerides. The supplements provide similar amounts of EPA + DHA esterified as either triglycerides; or esterified as phospholipids and triglycerides.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DHA-rich fish oil | Active comparator | Dietary Supplement: DHA-rich fish oil versus Phospholipid-rich fish oilDHA-rich fish oil versus Phospholipid-rich fish oil Fish oil in triglyceride form (12 capsules/d providing 575 mg/d EPA; 1843 mg/d DHA; 259 mg/d n-3 DPA) |
| Phospholipid-rich fish oil | Experimental | Dietary Supplement: DHA-rich fish oil versus Phospholipid-rich fish oilDHA-rich fish oil versus Phospholipid-rich fish oil Fish roe high in EPA/DHA phospholipids [(12 capsules/d providing 628 mg/d EPA; 1810 mg/d DHA; 137 mg/d n-3 docosapentaenoic acid (DPA)] |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Subject is male or female, 18-59 years of age, inclusive.
- Subject has a body mass index (BMI) of ≥18.50 and ≤29.99 kg/m2 at visit 1b (day -7).
- Subject has a score of 7 to 10 on the Vein Access Scale at visit 1b (day -7; Appendix 3).
- Subject has no health conditions that would prevent him/her from fulfilling the study requirements as judged by the Investigator on the basis of medical history and routine laboratory test results.
- Subject has a fasting TG 100-249 mg/dL at visit 1b (day -7). One venous retest allowed if ≥250 mg/dL.
Key exclusion criteria (11 listed)
- Subject is male or female, 18-59 years of age, inclusive.
- Subject has a body mass index (BMI) of ≥18.50 and ≤29.99 kg/m2 at visit 1b (day -7).
- Subject has a score of 7 to 10 on the Vein Access Scale at visit 1b (day -7; Appendix 3).
- Subject has no health conditions that would prevent him/her from fulfilling the study requirements as judged by the Investigator on the basis of medical history and routine laboratory test results.
- Subject has a fasting TG 100-249 mg/dL at visit 1b (day -7). One venous retest allowed if ≥250 mg/dL.
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 |
|---|---|---|
| DHA-rich fish oil versus Phospholipid-rich fish oilAlso: MOPL(TM)30, Marine Omega-3 Phospholipids, Herring Caviar PhospholipidsThis randomized, controlled crossover study will include four treatment visits (visits 2, 3, 4, and 5; days 0, 14, 42, and 56). Subjects will be randomly assigned, by sex and age, to their first treatment study product (active or control), which will be administered with a standardized low-choline, DHA-, EPA- free breakfast meal at t = 0 h. Subjects will consume placebo or phospholipid-rich fish oil for two weeks, washed out for 4 weeks, then treatments switched. Blood samples will be obtained for acute measurements on visits 2 and 4, via an indwelling venous catheter or venipuncture at t = 1, 2, 4, 6, 8, 10, and 12 h ± 5 min, to determine plasma fatty acid profile. Chronic fatty acid measurements will be determined after 2 weeks on visits 3 and 5. | Dietary supplement | DHA-rich fish oil, Phospholipid-rich fish oil |
Primary outcome
Area under the curve for plasma phosphatidylcholine omega-3 fatty acids
Time frame: pre-dose, 1, 2, 4, 6, 8, 10, 12 hours post-dose
The primary outcome variable will be the net incremental area under the curve (niAUC) for plasma phosphatidylcholine (PC) EPA + DHA from pre-meal (t = -0.5 h pre-dose) to 12 h post-dose (niAUC 0-12 h post-dose) measured at visits 2 and 4 (analyzed with and without normalization to the intake of EPA+DHA in each group).
7 secondary outcomes
Maximum concentration and Time to maximum concentration for plasma omega-3 phosphatidylcholine fatty acids
Time frame: pre-dose, 1, 2, 4, 6, 8, 10, 12 hours post-dose
Area under the curve for plasma phosphatidylcholine omega-3 fatty acids Part 2
Time frame: pre-dose, 1, 2, 4, 6, 8, 10, 12 hours post-dose
Plasma sphingomyelin and total plasma phosphatidylcholine
Time frame: pre-dose, 0, 1, 2, 4, 6, 8, 10, 12 hours post-dose
Fasting plasma lipoprotein lipids
Time frame: pre-dose
Gastrointestinal (GI) Tolerability Questionnaire
Time frame: 0, 12 hours post-dose
Product Acceptability Questionnaire
Time frame: 0, 12 hours post-dose
Adverse Events (AE)
Time frame: pre-treatment, 0, 12 hours post-dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2013.
- Background: PubMed 21291831Davidson MH, Maki KC, Bays H, Carter R, Ballantyne CM. Effects of prescription omega-3-acid ethyl esters on lipoprotein particle concentrations, apolipoproteins AI and CIII, and lipoprotein-associated phospholipase A(2) mass in statin-treated subjects with hypertriglyceridemia. J Clin Lipidol. 2009 Oct;3(5):332-40. doi: 10.1016/j.jacl.2009.08.001. Epub 2009 Aug 31.
- Background: PubMed 23312053Davidson MH, Johnson J, Rooney MW, Kyle ML, Kling DF. A novel omega-3 free fatty acid formulation has dramatically improved bioavailability during a low-fat diet compared with omega-3-acid ethyl esters: the ECLIPSE (Epanova((R)) compared to Lovaza((R)) in a pharmacokinetic single-dose evaluation) study. J Clin Lipidol. 2012 Nov-Dec;6(6):573-84. doi: 10.1016/j.jacl.2012.01.002. Epub 2012 Jan 24.
- Background: PubMed 9280188Grimsgaard S, Bonaa KH, Hansen JB, Nordoy A. Highly purified eicosapentaenoic acid and docosahexaenoic acid in humans have similar triacylglycerol-lowering effects but divergent effects on serum fatty acids. Am J Clin Nutr. 1997 Sep;66(3):649-59. doi: 10.1093/ajcn/66.3.649.
- Background: PubMed 19854375Maki KC, Reeves MS, Farmer M, Griinari M, Berge K, Vik H, Hubacher R, Rains TM. Krill oil supplementation increases plasma concentrations of eicosapentaenoic and docosahexaenoic acids in overweight and obese men and women. Nutr Res. 2009 Sep;29(9):609-15. doi: 10.1016/j.nutres.2009.09.004.
- Background: PubMed 21502576Miller M, Stone NJ, Ballantyne C, Bittner V, Criqui MH, Ginsberg HN, Goldberg AC, Howard WJ, Jacobson MS, Kris-Etherton PM, Lennie TA, Levi M, Mazzone T, Pennathur S; American Heart Association Clinical Lipidology, Thrombosis, and Prevention Committee of the Council on Nutrition, Physical Activity, and Metabolism; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular Nursing; Council on the Kidney in Cardiovascular Disease. Triglycerides and cardiovascular disease: a scientific statement from the American Heart Association. Circulation. 2011 May 24;123(20):2292-333. doi: 10.1161/CIR.0b013e3182160726. Epub 2011 Apr 18. No abstract available.
- Background: PubMed 10799369Mori TA, Burke V, Puddey IB, Watts GF, O'Neal DN, Best JD, Beilin LJ. Purified eicosapentaenoic and docosahexaenoic acids have differential effects on serum lipids and lipoproteins, LDL particle size, glucose, and insulin in mildly hyperlipidemic men. Am J Clin Nutr. 2000 May;71(5):1085-94. doi: 10.1093/ajcn/71.5.1085.
- Background: PubMed 21854650Schuchardt JP, Schneider I, Meyer H, Neubronner J, von Schacky C, Hahn A. Incorporation of EPA and DHA into plasma phospholipids in response to different omega-3 fatty acid formulations--a comparative bioavailability study of fish oil vs. krill oil. Lipids Health Dis. 2011 Aug 22;10:145. doi: 10.1186/1476-511X-10-145.
- Background: PubMed 21042875Ulven SM, Kirkhus B, Lamglait A, Basu S, Elind E, Haider T, Berge K, Vik H, Pedersen JI. Metabolic effects of krill oil are essentially similar to those of fish oil but at lower dose of EPA and DHA, in healthy volunteers. Lipids. 2011 Jan;46(1):37-46. doi: 10.1007/s11745-010-3490-4. Epub 2010 Nov 2.
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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.
Kevin C Maki, Ph. D study director
BioFortis
Kathleen Kelley, M.D. principal investigator
BioFortis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DHA-rich fish oil versus Phospholipid-rich fish oil in people with Hypertriglyceridemia, run by Arctic Nutrition AS at 1 site in United States.
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 11 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 25 Jul 2013. 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 United States. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kristen Sanoshy, MPH, RHIA ((630) 516-3990, kristen.sanoshy@mxns.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve for plasma phosphatidylcholine omega-3 fatty acids (time frame: pre-dose, 1, 2, 4, 6, 8, 10, 12 hours post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01908374, which also lists 8 linked publications.
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 25 Jul 2013.