Who is sponsoring NCT01813110?

NCT01813110 is sponsored by Penn State University.

What drugs are being tested in NCT01813110?

Interventions in NCT01813110: 4 g prescription omega-3 concentrate, Placebo.

What condition does NCT01813110 study?

NCT01813110 studies Inflammatory Responses.

Is NCT01813110 still recruiting?

NCT01813110 is currently completed. Last updated 16 August 2023.

Are results published for NCT01813110?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-08-16 · How we verify

NCT01813110: PRONOVA

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Effects of a Prescription Omega-3 Fatty Acid Concentrate in a Placebo-controlled Trial of Human Endotoxemia

Completed NA Results posted Last updated 16 August 2023

What this trial tests

NA trial testing 4 g prescription omega-3 concentrate in Inflammatory Responses in 21 participants. Completed in 1 April 2015.

Timeline

1 May 2014

Primary endpoint
1 April 2015

1 April 2015

Quick facts

Lead sponsor	Penn State University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	basic science
Enrollment	21
Start date	1 May 2014
Primary completion	1 April 2015
Estimated completion	1 April 2015
Sites	1 location across United States

Drugs / interventions tested

4 g prescription omega-3 concentrate — full drug profile →
Placebo

Conditions studied

Inflammatory Responses — all drugs for Inflammatory Responses →

Sponsor

Penn State University

Who can join

Adults 20 to 45, male only, with Inflammatory Responses. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Change in C Reactive Protein (CRP)
Time frame: 24 hours post endotoxin administration, following each 8 week intervention
Change in blood levels of CRP at 24 hours post endotoxin administration, after each 8 week intervention

Sponsor's own description

The purpose of this study is to assess whether the marine omega-3 fatty acids can attenuate inflammatory responses to endotoxin challenge.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Identification of specialized pro-resolving mediator clusters from healthy adults after intravenous low-dose endotoxin and omega-3 supplementation: a methodological validation.
Norris PC, Skulas-Ray AC, Riley I, Richter CK, et al · · 2018 · cited 82× · PMID 30575798 · DOI 10.1038/s41598-018-36679-4
Natural Compounds of Marine Origin as Inducers of Immunogenic Cell Death (ICD): Potential Role for Cancer Interception and Therapy.
Sansone C, Bruno A, Piscitelli C, Baci D, et al · · 2021 · cited 39× · PMID 33504012 · DOI 10.3390/cells10020231
Effect of omega-3 ethyl esters on the triglyceride-rich lipoprotein response to endotoxin challenge in healthy young men.
Walker RE, Richter CK, Skulas-Ray AC, Flock MR, et al · · 2023 · cited 5× · PMID 36907552 · DOI 10.1016/j.jlr.2023.100353

Verify or expand the search:

Other recruiting trials for Inflammatory Responses

Currently open trials in the same condition.

NCT07329595 — Monitoring the Clinical and Immunological Effects of Microbiome Changes Following Severe Burn Injury · recruiting

Other Penn State University trials

Trials by the same sponsor.

NCT07147387 — Lions Hearts: A Community Approach to Multigenerational Cardiovascular Disease Risk · NA · not yet recruiting
NCT07266506 — Development of an Eating Behavior Risk Score · NA · not yet recruiting
NCT07229781 — Mediterranean Diet and Blood Sugar Study · NA · not yet recruiting
NCT07235358 — Cardiometabolic Effects of Pecan Snacking in Prediabetes · NA · not yet recruiting
NCT06823518 — Thrive Initiative Parent-Education Programming Study · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01813110 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Penn State University
Last refreshed: 16 August 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01813110.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing