Krill Oil Study Compared to Fish Oil | NCT01323036

Studies
Krill Oil Study Compared to Fish Oil

NCT01323036

Sponsor

University of Manitoba

Status

Completed

Last Update Posted

Nov 22, 2012Estimated

Enrollment

24Actual

Phase

Not Applicable

Conditions

Healthy Volunteers

Interventions

Krill oil
Fish Oil

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2011

Primary Completion Date

Dec 2011Actual

Completion Date

Nov 2012Actual

First Submitted Date

Mar 23, 2011

First Submission Date that Met QC Criteria

Mar 24, 2011

First Posted Date

Mar 25, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 21, 2012

Last Update Posted Date

Nov 22, 2012Estimated

Name	Class
Enzymotec	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The main purpose of the study is to evaluate the absorption of omega-3 fatty acids into the blood following consumption of krill oil compared with fish oil and placebo.

Detailed Description

The main purpose of the study is to evaluate the absorption of omega-3 fatty acids into the blood following consumption of krill oil compared with fish oil and placebo. An additional purpose is to evaluate the lipid-lowering efficacy and safety of consumption of Krill Oil and Fish Oil to a placebo product. It has been shown that the ingestion of Krill Oil leads to better absorption of omega-3 fatty acids compared to ingestion of Fish Oil. It was also shown that consumption of krill oil and fish oil result in a favorable modification of lipid profiles. Therefore, it is anticipated that consumption of these krill oil and fish oil will improve lipid profile, as well as other health-related markers and will be safe and well tolerated.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Krill Oil	Experimental		Dietary Supplement: Krill oil
Fish Oil	Experimental		Dietary Supplement: Fish Oil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Krill oil	Dietary Supplement	Krill oil:Total omega-3 fatty acids: 560-660 mg and Astaxanthin: 1800 µg	Krill Oil

Measure	Description	Time Frame
Bioavailability		1 month

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy men and premenopausal not pregnant or nursing women between 18 and 49 years old.

Exclusion Criteria:

smokers
rheumatoid arthritis
chronic illness
cardiovascular problems
dyslipidemia
liver and kidney disease
diabetes
endocrine or metabolic disease
inflammatory bowel disease
pancreatitis
gallbladder or biliary disease
neurological/psychological disease
bleeding disorders
experienced platelet abnormalities
gastrointestinal disorders that could interfere with fat absorption
hypertension
history of cancer
an intention to lose weight
use of anticoagulant
serum triglycerides (TG) >200 mg/dL, and/or total cholesterol (TC) >240 mg/dL, and/or LDL-cholesterol (LDL-C) >160 mg/dL
hypertension or lipid lowering medications
consumption of more than one alcoholic drinks/day
Consumption of more than one fish or seafood serving
one month prior to the start of the study
omega-6 fatty acids in the past 6 months
planned to consume seafood products or fish or to use any omega-3 or omega-6 fatty acids nutritional supplements at anytime in the duration of the study
planned to to become pregnant during the study period
BMI>28
allergies to fish seafood or corn

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

49 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Richardson Centre for Functional Foods and Nutraceuticals		Winnipeg	Manitoba	R3T 2N2	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26537218	Derived	Ramprasath VR, Eyal I, Zchut S, Shafat I, Jones PJ. Supplementation of krill oil with high phospholipid content increases sum of EPA and DHA in erythrocytes compared with low phospholipid krill oil. Lipids Health Dis. 2015 Nov 4;14:142. doi: 10.1186/s12944-015-0142-y.
24304605	Derived	Ramprasath VR, Eyal I, Zchut S, Jones PJ. Enhanced increase of omega-3 index in healthy individuals with response to 4-week n-3 fatty acid supplementation from krill oil versus fish oil. Lipids Health Dis. 2013 Dec 5;12:178. doi: 10.1186/1476-511X-12-178.

ID	Term
D009821	Oils
D008055	Lipids