NCT01078909

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2010

Completed
1.6 years until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

June 14, 2017

Completed
Last Updated

August 21, 2023

Status Verified

August 1, 2023

Enrollment Period

1.1 years

First QC Date

March 1, 2010

Results QC Date

September 16, 2015

Last Update Submit

August 16, 2023

Conditions

Cardiovascular DiseaseInflammation

Keywords

Cardiovascular diseaseInflammationFish OilOmega-3 Fatty AcidsLPSEndotoxin

Outcome Measures

Primary Outcomes (2)

  • Mean Concentrations of Inflammatory Markers (TNF-alpha and IL-6) Following 5 Months of Treatment

    5 months

  • Mean Concentrations of CRP Following 5 Months of Treatment

    5 months

Secondary Outcomes (1)

  • Change in Lipid Mediators

    1, 2, 3 and 5 days post LPS administration

Study Arms (5)

300mg Fish Oil (EPA + DHA) Supplement

EXPERIMENTAL
Biological: Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA)

600mg Fish Oil (EPA+DHA) Supplement

EXPERIMENTAL
Biological: Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA)

900mg Fish Oil (EPA + DHA) Supplement

EXPERIMENTAL
Biological: Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA)

1800mg Fish Oil (EPA + DHA) Supplement

EXPERIMENTAL
Biological: Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA)

Placebo

PLACEBO COMPARATOR
Biological: Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA)

Interventions

Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA)BIOLOGICAL

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

Also known as: Omega-3 Fatty Acids, Fish Oil
1800mg Fish Oil (EPA + DHA) Supplement300mg Fish Oil (EPA + DHA) Supplement600mg Fish Oil (EPA+DHA) Supplement900mg Fish Oil (EPA + DHA) SupplementPlacebo

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State University

University Park, Pennsylvania, 16802, United States

Location

Related Publications (1)

  • 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.

    PMID: 24252845DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesInflammation

Interventions

Eicosapentaenoic AcidDocosahexaenoic AcidsFatty Acids, Omega-3Fish Oils

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsEicosanoidsFatty Acids, UnsaturatedFatty AcidsOils

Results Point of Contact

Title
Dr. Penny Kris-Etherton
Organization
The Pennsylvania State University
pmk3@psu.edu
814-863-2923

Study Officials

  • Gordon L Jensen, MD, PhD

    Penn State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2010

First Posted

March 2, 2010

Study Start

October 1, 2011

Primary Completion

November 1, 2012

Study Completion

April 1, 2014

Last Updated

August 21, 2023

Results First Posted

June 14, 2017

Record last verified: 2023-08

Locations

US(1)