Dose Response Effects of Marine Omega-3 Fatty Acids on Inflammation

August 16, 2023 updated by: Penn State University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

125

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • University Park, Pennsylvania, United States, 16802
        • Penn State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Biological: Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA)
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
Other Names:
  • Omega-3 Fatty Acids
  • Fish Oil
Experimental: 300mg Fish Oil (EPA + DHA) Supplement
Biological: Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA)
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
Other Names:
  • Omega-3 Fatty Acids
  • Fish Oil
Experimental: 600mg Fish Oil (EPA+DHA) Supplement
Biological: Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA)
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
Other Names:
  • Omega-3 Fatty Acids
  • Fish Oil
Experimental: 900mg Fish Oil (EPA + DHA) Supplement
Biological: Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA)
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
Other Names:
  • Omega-3 Fatty Acids
  • Fish Oil
Experimental: 1800mg Fish Oil (EPA + DHA) Supplement
Biological: Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA)
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
Other Names:
  • Omega-3 Fatty Acids
  • Fish Oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean Concentrations of Inflammatory Markers (TNF-alpha and IL-6) Following 5 Months of Treatment
Time Frame: 5 months
5 months
Mean Concentrations of CRP Following 5 Months of Treatment
Time Frame: 5 months
5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Lipid Mediators
Time Frame: 1, 2, 3 and 5 days post LPS administration
0 Participants Analyzed; Lipid mediators were unable to be detected therefore there are no data to report.
1, 2, 3 and 5 days post LPS administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Penn State University

Collaborators

United States Department of Agriculture (USDA)

Investigators

  • Principal Investigator: Gordon L Jensen, MD, PhD, Penn State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

March 1, 2010

First Submitted That Met QC Criteria

March 1, 2010

First Posted (Estimated)

March 2, 2010

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 16, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PKE LPS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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