Study Comparing Fish Oil and Krill Oil

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.

Study Overview

• Status: Terminated
• Conditions: Inflammation; Dyslipidemia
• Intervention / Treatment: Dietary supplement: Fish oil; Dietary supplement: Krill oil

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 Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Jean Mayer Human Nutrition Research Center on Aging at Tufts University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Omega-3 index	red blood cell membrane levels of EPA and DHA, as percent of total fatty acids	10 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tufts University
• Collaborators: Prevention Pharmaceuticals
• Investigators: Principal Investigator: Stefania Lamon-Fava, Ph.D., Tufts University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: December 23, 2015
• First Submitted That Met QC Criteria: January 27, 2016
• First Posted (Estimate): February 1, 2016

Study Record Updates

• Last Update Posted (Actual): April 26, 2017
• Last Update Submitted That Met QC Criteria: April 24, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Metabolic Syndrome; DHA; EPA; fish oil; krill oil
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Lipid Metabolism Disorders; Inflammation; Dyslipidemias
• Other Study ID Numbers: 11787

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No