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

NCT01078909 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2023-08-21

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • United States Department of Agriculture (USDA)

    collaborator FED
  • Penn State University

    lead OTHER

Principal Investigators

  • Gordon L Jensen, MD, PhD · Penn State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-11-30
Completion
2014-04-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01078909 on ClinicalTrials.gov