NCT03347006

SPM Regulation by Fish Oil Supplements in Healthy Volunteers

Completed NA Results posted Last updated 25 May 2025

What this trial tests

NA trial testing SPM Active in Healthy Volunteers in 22 participants. Completed in 15 June 2018.

Timeline

20 March 2017

Primary endpoint
15 June 2018

15 June 2018

Quick facts

Lead sponsor	Queen Mary University of London
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	basic science
Enrollment	22
Start date	20 March 2017
Primary completion	15 June 2018
Estimated completion	15 June 2018
Sites	1 location across United Kingdom

Drugs / interventions tested

• SPM Active

Conditions studied

• Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Queen Mary University of London

Who can join

Adults 18 to 45, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Increase in the Average Peripheral Blood SPM Levels Primary · outcomes will be measured 24h post supplementation and compared with baseline values (0h)

The Primary endpoint of the study will be an increase in peripheral blood SPM levels that will be measured calculated by measuring pre-supplement SPM levels to values measured in plasma after supplementation.

Group	Value	95% CI
Placebo	56.49	± 42.54
Dose 1	56.91	± 38.50
Dose 2	108.8	± 110.3
Dose 3	139.7	± 83.44

Percentage Change in Omega-3 Fatty Acid Levels From Baseline After 24 Hours Secondary · Outcomes will be measured 24h post supplementation and compared with baseline values (at 0h)

Measure ability of peripheral blood neutrophils to uptake S. aureus following pre- and post- supplementation. Looking at relationship between amount of omega-3 fatty acids ingested, the increase in the blood levels of these molecules and white blood cell function.

Group	Value	95% CI
Placebo	23.19	± 12.90
Dose 1	70.01	± 28.31
Dose 2	22.60	± 12.26
Dose 3	89.12	± 48.61

Changes in the Expression of Peripheral Blood Neutrophil Activation Markers Secondary · outcomes measured 24h post supplementation and compared with baseline values (at 0h)

Changes in the expression of protein linked with neutrophil activation, determined by comparing expression levels of this protein in peripheral blood cells pre- and post supplementation.

Group	Value	95% CI
Placebo	31.97	± 8.556
Dose 1	30.90	± 8.379
Dose 2	6.723	± 5.859
Dose 3	13.93	± 6.177

Sponsor's own description

A randomised, double-blind, placebo-controlled study to determine whether fish oil supplementation regulates peripheral levels of specialized pro-resolving mediators and white blood cell responses in healthy volunteers

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Enriched Marine Oil Supplements Increase Peripheral Blood Specialized Pro-Resolving Mediators Concentrations and Reprogram Host Immune Responses: A Randomized Double-Blind Placebo-Controlled Study.
   Souza PR, Marques RM, Gomez EA, Colas RA, et al · · 2020 · cited 115× · PMID 31829100 · DOI 10.1161/circresaha.119.315506