Study Comparing Fish Oil and Krill Oil

Sponsor

Tufts University (Other)

Overall Status

Terminated

CT.gov ID

NCT02670356

Collaborator

Prevention Pharmaceuticals (Other)

Enrollment

Location

Arms

Actual Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammation Dyslipidemia	Dietary Supplement: Fish oil Dietary Supplement: Krill oil	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

2 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Study Comparing Fish Oil and Krill Oil

Actual Study Start Date :

Oct 1, 2015

Actual Primary Completion Date :

Jul 1, 2016

Actual Study Completion Date :

Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fish oil fish oil, 1500 mg/day, EPA:DHA ratio of 4:1, each capsule containing 750 mg total EPA+DHA, 2 capsules/day for 10 weeks	Dietary Supplement: Fish oil two 750 mg/capsules/day
Experimental: krill oil krill oil, 300 mg/day, each capsule containing 74 mg total EPA+DHA , 1 capsule/day for 10 weeks	Dietary Supplement: Krill oil one 300 mg capsule/day

Arm

Intervention/Treatment

Experimental: Fish oil

fish oil, 1500 mg/day, EPA:DHA ratio of 4:1, each capsule containing 750 mg total EPA+DHA, 2 capsules/day for 10 weeks

Dietary Supplement: Fish oil

two 750 mg/capsules/day

Experimental: krill oil

krill oil, 300 mg/day, each capsule containing 74 mg total EPA+DHA , 1 capsule/day for 10 weeks

Dietary Supplement: Krill oil

one 300 mg capsule/day

Outcome Measures

Primary Outcome Measures

Omega-3 index [10 weeks]
red blood cell membrane levels of EPA and DHA, as percent of total fatty acids

Secondary Outcome Measures

interleukin-6 (IL-6) [10 weeks]
plasma levels as pg/mL
Tumor necrosis factor alpha (TNF-alpha) [10 weeks]
plasma levels as pg/mL
Monocyte chemoattractant protein 1 (MCP-1) [10 weeks]
plasma levels as pg/mL
Total cholesterol [10 weeks]
plasma levels as mg/dL
LDL cholesterol [10 weeks]
plasma levels as mg/dL
HDL cholesterol [10 weeks]
plasma levels as mg/dL
TG [10 weeks]
plasma levels as mg/dL

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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