Clinical trial NCT01323036: Krill Oil Study Compared to Fish Oil
Official title: Assessment of Bioavailability of Krill Oil Compared to Fish Oil in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Enzymotec
First posted: 2011-03-25
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Bioavailability
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Richardson Centre for Functional Foods and Nutraceuticals
state: Manitoba
Study officials:
References:
citation: 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.
citation: 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.