- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01323036
Krill Oil Study Compared to Fish Oil (Krill)
November 21, 2012 updated by: Dr. Peter Jones, University of Manitoba
Assessment of Bioavailability of Krill Oil Compared to Fish Oil in Healthy Volunteers
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R3T 2N2
- Richardson Centre for Functional Foods and Nutraceuticals
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 49 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Krill Oil
|
Krill oil:Total omega-3 fatty acids: 560-660 mg and Astaxanthin: 1800 µg
|
Experimental: Fish Oil
|
Fish oil: Total omega-3 fatty acids: 560-660 mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Bioavailability
Time Frame: 1 month
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
November 1, 2012
Study Registration Dates
First Submitted
March 23, 2011
First Submitted That Met QC Criteria
March 24, 2011
First Posted (Estimate)
March 25, 2011
Study Record Updates
Last Update Posted (Estimate)
November 22, 2012
Last Update Submitted That Met QC Criteria
November 21, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- B2011:014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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