Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-03-01 @ 9:55 PM
Study NCT ID:
NCT02670356
Status:
TERMINATED
Last Update Posted:
2017-04-26
First Post:
2015-12-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Comparing Fish Oil and Krill Oil
Sponsor:
Tufts University
Organization:
Study Overview
Official Title:
Study Comparing Fish Oil and Krill Oil
Status:
TERMINATED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study stopped by the company funding the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are omega-3 fatty acids found in fish oil and in krill oil. The purpose of this study is to compare the effects of the recommended dose of a fish oil supplement (Omax3 4:1 EPA:DHA; recommended daily dose 1650 mg - totaling 1500 mg EPA+DHA) and a krill oil supplement (MegaRed; recommended daily dose 300 mg - totaling 74 mg EPA+DHA) on omega-3 index, plasma biomarkers of inflammation and inflammatory cell activation, and plasma lipid levels in subjects with metabolic syndrome.
Detailed Description:
Inflammation plays a pivotal role in the pathogenesis of several chronic diseases including cardiovascular disease and diabetes mellitus. There has been some evidence that fish oil, containing the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), reduces the risk or severity of these diseases, leading several government and health organizations to advocate an increased consumption of fish or fish oil. Fish oil contains EPA and DHA either as triglycerides or as ethyl esters. Recently, krill oil has gained popularity as an EPA and DHA supplement. Krill oil contains EPA and DHA in phospholipid, triglyceride, and free fatty acid form.
Some studies have shown that the bioavailability of EPA and DHA in krill oil is higher than in fish oil and that smaller doses of krill oil are therefore sufficient to observe a significant effect on the desired outcome (inflammation, plasma lipid levels).
The central hypothesis of this proposal is that the dose of the EPA and DHA omega-3 fatty acids is more important than their bioavailability in effecting changes in systemic inflammation and lipid metabolism.
Some studies have shown that the bioavailability of EPA and DHA in krill oil is higher than in fish oil and that smaller doses of krill oil are therefore sufficient to observe a significant effect on the desired outcome (inflammation, plasma lipid levels).
The central hypothesis of this proposal is that the dose of the EPA and DHA omega-3 fatty acids is more important than their bioavailability in effecting changes in systemic inflammation and lipid metabolism.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: