Study Comparing Fish Oil and Krill Oil

Inflammation Clinical Trial

Official title:

Study Comparing Fish Oil and Krill Oil

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02670356
• Other study ID #: 11787
• Status: Terminated
• Phase: N/A
• First received: December 23, 2015
• Last updated: April 24, 2017
• Start date: October 2015
• Est. completion date: July 2016

Study information

• Verified date: April 2017
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Inflammation

Intervention

Dietary Supplement:
• Fish oil
two 750 mg/capsules/day
• Krill oil
one 300 mg capsule/day

Locations

Country	Name	City	State
United States	Jean Mayer Human Nutrition Research Center on Aging at Tufts University	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Tufts University	Prevention Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Omega-3 index	red blood cell membrane levels of EPA and DHA, as percent of total fatty acids	10 weeks
Secondary	interleukin-6 (IL-6)	plasma levels as pg/mL	10 weeks
Secondary	Tumor necrosis factor alpha (TNF-alpha)	plasma levels as pg/mL	10 weeks
Secondary	Monocyte chemoattractant protein 1 (MCP-1)	plasma levels as pg/mL	10 weeks
Secondary	Total cholesterol	plasma levels as mg/dL	10 weeks
Secondary	LDL cholesterol	plasma levels as mg/dL	10 weeks
Secondary	HDL cholesterol	plasma levels as mg/dL	10 weeks
Secondary	TG	plasma levels as mg/dL	10 weeks