Study Comparing Fish Oil and Krill Oil
Primary Purpose
Inflammation, Dyslipidemia
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fish oil
Krill oil
Sponsored by
About this trial
This is an interventional treatment trial for Inflammation focused on measuring fish oil, EPA, DHA, krill oil, Metabolic Syndrome
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
Sites / Locations
- Jean Mayer Human Nutrition Research Center on Aging at Tufts University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Fish oil
krill oil
Arm Description
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
krill oil, 300 mg/day, each capsule containing 74 mg total EPA+DHA , 1 capsule/day for 10 weeks
Outcomes
Primary Outcome Measures
Omega-3 index
red blood cell membrane levels of EPA and DHA, as percent of total fatty acids
Secondary Outcome Measures
interleukin-6 (IL-6)
plasma levels as pg/mL
Tumor necrosis factor alpha (TNF-alpha)
plasma levels as pg/mL
Monocyte chemoattractant protein 1 (MCP-1)
plasma levels as pg/mL
Total cholesterol
plasma levels as mg/dL
LDL cholesterol
plasma levels as mg/dL
HDL cholesterol
plasma levels as mg/dL
TG
plasma levels as mg/dL
Full Information
NCT ID
NCT02670356
First Posted
December 23, 2015
Last Updated
April 24, 2017
Sponsor
Tufts University
Collaborators
Prevention Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT02670356
Brief Title
Study Comparing Fish Oil and Krill Oil
Official Title
Study Comparing Fish Oil and Krill Oil
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Study stopped by the company funding the study
Study Start Date
October 2015 (Actual)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tufts University
Collaborators
Prevention Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Dyslipidemia
Keywords
fish oil, EPA, DHA, krill oil, Metabolic Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fish oil
Arm Type
Experimental
Arm Description
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
Arm Title
krill oil
Arm Type
Experimental
Arm Description
krill oil, 300 mg/day, each capsule containing 74 mg total EPA+DHA , 1 capsule/day for 10 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Fish oil
Intervention Description
two 750 mg/capsules/day
Intervention Type
Dietary Supplement
Intervention Name(s)
Krill oil
Intervention Description
one 300 mg capsule/day
Primary Outcome Measure Information:
Title
Omega-3 index
Description
red blood cell membrane levels of EPA and DHA, as percent of total fatty acids
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
interleukin-6 (IL-6)
Description
plasma levels as pg/mL
Time Frame
10 weeks
Title
Tumor necrosis factor alpha (TNF-alpha)
Description
plasma levels as pg/mL
Time Frame
10 weeks
Title
Monocyte chemoattractant protein 1 (MCP-1)
Description
plasma levels as pg/mL
Time Frame
10 weeks
Title
Total cholesterol
Description
plasma levels as mg/dL
Time Frame
10 weeks
Title
LDL cholesterol
Description
plasma levels as mg/dL
Time Frame
10 weeks
Title
HDL cholesterol
Description
plasma levels as mg/dL
Time Frame
10 weeks
Title
TG
Description
plasma levels as mg/dL
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefania Lamon-Fava, Ph.D.
Organizational Affiliation
Tufts University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jean Mayer Human Nutrition Research Center on Aging at Tufts University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Study Comparing Fish Oil and Krill Oil
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