Study Comparing Fish Oil and Krill Oil

Not Applicable

Terminated

• Conditions: Inflammation; Dyslipidemia
• Interventions: Dietary Supplement: Krill oil; Dietary Supplement: Fish oil

• Registration Number: NCT02670356
• Lead Sponsor: Tufts University

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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-12-23
• Study First Submitted QC: 2016-01-27
• Study First Posted: 2016-02-01
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-24
• Last Update Posted: 2017-04-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
krill oil	Krill oil	krill oil, 300 mg/day, each capsule containing 74 mg total EPA+DHA , 1 capsule/day for 10 weeks
Fish oil	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
interleukin-6 (IL-6)	10 weeks	plasma levels as pg/mL
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

Trial Locations

Locations (1)

Jean Mayer Human Nutrition Research Center on Aging at Tufts University; 🇺🇸 Boston, Massachusetts, United States