Clinical trial NCT02670356: Study Comparing Fish Oil and Krill Oil
Official title: Study Comparing Fish Oil and Krill Oil
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Inflammation
Dyslipidemia
Keywords: fish oil
EPA
DHA
krill oil
Metabolic Syndrome
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: Prevention Pharmaceuticals
First posted: 2016-02-01
Enrollment: 2
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* fasting plasma triglyceride levels between 150 and 500 mg/dL
* C-reactive protein (CRP) levels ≥2 µg/mL
* at least one of the following criteria for the definition of metabolic syndrome: abdominal obesity (waist circumference \>40 inches in men and \>35 inches in women), hypertension (blood pressure ≥130/≥85 mmHg or use of anti-hypertensive medications), and fasting glucose ≥110 mg/dL.

Exclusion Criteria:

* high-fish diets (\>2 fish meals/week)
* taking fish oil supplements or supplements containing EPA or DHA
* regular use of anti-inflammatory medications
* Above normal coagulation time or use of anticoagulant medications
* allergy to fish, fish oil, or shellfish
* uncontrolled thyroid dysfunction
* insulin-dependent type 2 diabetes mellitus
* kidney or liver disease
* smoking
* drinking more than 7 alcoholic drinks/week
* use of lipid-lowering medications or medications known to alter lipoprotein metabolism

Primary outcomes:
measure: Omega-3 index
timeFrame: 10 weeks
Secondary outcomes:
measure: interleukin-6 (IL-6)
timeFrame: 10 weeks
measure: Tumor necrosis factor alpha (TNF-alpha)
timeFrame: 10 weeks
measure: Monocyte chemoattractant protein 1 (MCP-1)
timeFrame: 10 weeks
measure: Total cholesterol
timeFrame: 10 weeks
measure: LDL cholesterol
timeFrame: 10 weeks
measure: HDL cholesterol
timeFrame: 10 weeks
measure: TG
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Jean Mayer Human Nutrition Research Center on Aging at Tufts University
state: Massachusetts
Study officials:
affiliation: Tufts University
name: Stefania Lamon-Fava, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: