SPM Regulation by Fish Oil Supplements in Healthy Volunteers

NCT03347006 | Completed Results DMC

• 2 other identifiers: 01154916/LO/2182
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Increase in the Average Peripheral Blood SPM Levels

  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.

  outcomes will be measured 24h post supplementation and compared with baseline values (0h)

Secondary Outcomes (2)

• Percentage Change in Omega-3 Fatty Acid Levels From Baseline After 24 Hours

  Outcomes will be measured 24h post supplementation and compared with baseline values (at 0h)

• Changes in the Expression of Peripheral Blood Neutrophil Activation Markers

  outcomes measured 24h post supplementation and compared with baseline values (at 0h)

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Placebo control

Dietary Supplement: SPM Active

Dose 1

EXPERIMENTAL

1.5 g of omega-3 supplement

Dietary Supplement: SPM Active

Dose 2

EXPERIMENTAL

3.0 g of omega-3 supplement

Dietary Supplement: SPM Active

Dose 3

EXPERIMENTAL

4.5 g of omega-3 supplement

Dietary Supplement: SPM Active

Interventions

SPM Active DIETARY_SUPPLEMENT

Supplement or placebo will be administered orally between 9 am to 9:30 am. * Each participant will give a baseline blood sample then they will be given one of the randomly allocated three doses of fish oil supplement, or a matching placebo in one of 8 study groups \[this will be on a 1:1:1:1:1:1:1:1 ratio\]. Blood will be collected again at 2h, 4h, 6h and 24h after supplementation/placebo, 12ml per time interval.

Dose 1; Dose 2; Dose 3; Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• For participants to be included in the study they will need to meet the following criteria:
• Able to provide informed consent
• Men and women between the age of 18 and 45
• Declare not to be taking aspirin, other NSAIDS, other form of medication or omega-3 fatty acid supplements for more than 2 weeks prior to screening and the duration of the participation.
• Willingness to abstain from eating fish for 2 days before each study visit
• Willingness to abstain from alcohol consumption for at least 24h prior to each study visit
• Willingness to abstain from caffeine as directed before and during study

You may not qualify if:

• \) History of, chronic disorders, cardiovascular disease (e.g., heart disease, stroke), cancer, or diabetes or significant genetically inherited conditions.
• \) Pregnancy or breast-feeding. 3) Hypothyroidism in the opinion of the investigator. 4) Liver disease in the opinion of the investigator. 5) Any abnormality or pre-existing disease which, in the opinion of the investigator, might either expose the subject to risk, or influence the validity of the results.
• \) Women of childbearing potential not taking adequate methods of contraception 7) Inability to read and write in English 8) Participation in a clinical study of a new chemical entity, biological product or a prescription medicine, or loss of more than 400 mL blood, within the previous 3 months 9) Anyone who is currently smoking or used to smoke 10) Presence or history of drug or alcohol abuse or intake of more than the amount of alcohol in the current guidelines on alcohol consumption

Sponsors & Collaborators

• Queen Mary University of London: lead
• Metagenics, Inc.: collaborator

Study Sites (1)

Queen Mary University of London

London, EC1M 6BQ, United Kingdom

Location

Related Publications (1)

• Souza PR, Marques RM, Gomez EA, Colas RA, De Matteis R, Zak A, Patel M, Collier DJ, Dalli J. Enriched Marine Oil Supplements Increase Peripheral Blood Specialized Pro-Resolving Mediators Concentrations and Reprogram Host Immune Responses: A Randomized Double-Blind Placebo-Controlled Study. Circ Res. 2020 Jan 3;126(1):75-90. doi: 10.1161/CIRCRESAHA.119.315506. Epub 2019 Dec 12.

  PMID: 31829100 DERIVED

Results Point of Contact

• Title: Professor Jesmond Dalli
• Organization: Queen Mary University of London

j.dalli@qmul.ac.uk

+442078828263

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind placebo controlled
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: SPM Active is the supplement tested in this study

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: November 20, 2017
• Study Start: March 20, 2017
• Primary Completion: June 15, 2018
• Study Completion: June 15, 2018
• Last Updated: May 25, 2025
• Results First Posted: May 25, 2025

Record last verified: 2025-05

Locations

GB (1)