Dose Response Effects of Marine Omega-3 Fatty Acids on Inflammation
Primary Purpose
Cardiovascular Disease, Inflammation
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA)
Sponsored by

About this trial
This is an interventional treatment trial for Cardiovascular Disease focused on measuring Cardiovascular disease, Inflammation, Fish Oil, Omega-3 Fatty Acids, LPS, Endotoxin
Eligibility Criteria
Inclusion Criteria:
- Healthy men and non-pregnant/lactating women between the ages of 20 and 45
- BMI >19.9 and <30.0
- Able to give written informed consent and willing to comply with all study- related procedures.
Exclusion Criteria:
- Previous history of heart disease or diabetes
- Renal Insufficiency
- Chronic anti-inflammatory use
- Systolic blood pressure < 90
- Individuals currently using tobacco products or have done so in the previous 30 days
- Individuals taking Omega-3 fatty acid supplements or their usual intake of fish is greater than 3-4 servings per month.
Sites / Locations
- Penn State University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
300mg Fish Oil (EPA + DHA) Supplement
600mg Fish Oil (EPA+DHA) Supplement
900mg Fish Oil (EPA + DHA) Supplement
1800mg Fish Oil (EPA + DHA) Supplement
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Mean Concentrations of Inflammatory Markers (TNF-alpha and IL-6) Following 5 Months of Treatment
Mean Concentrations of CRP Following 5 Months of Treatment
Secondary Outcome Measures
Change in Lipid Mediators
0 Participants Analyzed; Lipid mediators were unable to be detected therefore there are no data to report.
Full Information
NCT ID
NCT01078909
First Posted
March 1, 2010
Last Updated
August 16, 2023
Sponsor
Penn State University
Collaborators
United States Department of Agriculture (USDA)
1. Study Identification
Unique Protocol Identification Number
NCT01078909
Brief Title
Dose Response Effects of Marine Omega-3 Fatty Acids on Inflammation
Official Title
Dose Response Effects of Marine Omega-3 Fatty Acids on Inflammation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Penn State University
Collaborators
United States Department of Agriculture (USDA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine the lowest effective dose of EPA + DHA (300, 600, 900 and 1,800 mg/day delivered as fish oil supplements) that significantly attenuates the inflammatory response to in vivo and ex vivo endotoxin challenge as measured by the production over time of several inflammatory markers.
Detailed Description
Inflammation is an important biological process initiated by the immune system in response to injury, irritation or infection. Prolonged or chronic inflammation is involved in the etiology of several diseases such as cardiovascular disease (CVD), diabetes, rheumatoid arthritis, cancer, and neurodegenerative diseases such as Alzheimer disease. The evidence base clearly demonstrates benefits of diet in ameliorating inflammation and reducing the burden of chronic disease. With respect to marine-derived omega-3 fatty acids and various markers of inflammation related to cardiovascular disease (CVD), both population studies and randomized controlled supplementation trials have yielded mixed results.
Some studies have demonstrated a dose-response relationship between dietary eicosapentaenoic acid and docosahexaenoic acid (EPA + DHA) and increased membrane (phospholipid) EPA and DHA. Red blood cell (RBC) EPA + DHA content has been proposed as a potential, modifiable marker for coronary heart disease (CHD) risk. It is well established that these fatty acids are precursors of series-3 prostanoids, thromboxanes, 5-series leukotrienes, and novel lipid mediators such as resolvins and protectins that have anti-inflammatory effects. We hypothesize that nutritionally-relevant intakes of omega-3 fatty acids are able to blunt the usual response to an inflammatory stimulus. We propose to test this hypothesis using both in vivo (i.v. endotoxin challenge) and ex vivo (endotoxin-stimulated monocytes) models in a 6-month, dose-response study with marine-derived omega-3 fatty acid supplements in healthy volunteers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, Inflammation
Keywords
Cardiovascular disease, Inflammation, Fish Oil, Omega-3 Fatty Acids, LPS, Endotoxin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
125 (Actual)
8. Arms, Groups, and Interventions
Arm Title
300mg Fish Oil (EPA + DHA) Supplement
Arm Type
Experimental
Arm Title
600mg Fish Oil (EPA+DHA) Supplement
Arm Type
Experimental
Arm Title
900mg Fish Oil (EPA + DHA) Supplement
Arm Type
Experimental
Arm Title
1800mg Fish Oil (EPA + DHA) Supplement
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA)
Other Intervention Name(s)
Omega-3 Fatty Acids, Fish Oil
Intervention Description
Comparison of 4 doses of EPA+DHA on in vivo and ex vivo (monocytes) response to an inflammatory stimulus (endotoxin) following a 6 month supplementation period
Primary Outcome Measure Information:
Title
Mean Concentrations of Inflammatory Markers (TNF-alpha and IL-6) Following 5 Months of Treatment
Time Frame
5 months
Title
Mean Concentrations of CRP Following 5 Months of Treatment
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Change in Lipid Mediators
Description
0 Participants Analyzed; Lipid mediators were unable to be detected therefore there are no data to report.
Time Frame
1, 2, 3 and 5 days post LPS administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy men and non-pregnant/lactating women between the ages of 20 and 45
BMI >19.9 and <30.0
Able to give written informed consent and willing to comply with all study- related procedures.
Exclusion Criteria:
Previous history of heart disease or diabetes
Renal Insufficiency
Chronic anti-inflammatory use
Systolic blood pressure < 90
Individuals currently using tobacco products or have done so in the previous 30 days
Individuals taking Omega-3 fatty acid supplements or their usual intake of fish is greater than 3-4 servings per month.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gordon L Jensen, MD, PhD
Organizational Affiliation
Penn State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State University
City
University Park
State/Province
Pennsylvania
ZIP/Postal Code
16802
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24252845
Citation
Flock MR, Skulas-Ray AC, Harris WS, Etherton TD, Fleming JA, Kris-Etherton PM. Determinants of erythrocyte omega-3 fatty acid content in response to fish oil supplementation: a dose-response randomized controlled trial. J Am Heart Assoc. 2013 Nov 19;2(6):e000513. doi: 10.1161/JAHA.113.000513.
Results Reference
derived
Learn more about this trial
Dose Response Effects of Marine Omega-3 Fatty Acids on Inflammation
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