N/A
Completed N=22
SPM Regulation by Fish Oil Supplements in Healthy Volunteers
Healthy Volunteers
Source: ClinicalTrials.gov NCT03347006 ↗
Enrolled (actual)
22
Serious AEs
0.0%
Results posted
May 2025
Primary outcomePrimary: Increase in the Average Peripheral Blood SPM Levels — 56.49; 56.91; 108.8; 139.7 pg/mL
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Increase in the Average Peripheral Blood SPM Levels |
56.49; 56.91; 108.8; 139.7 | — |
| SECONDARY Percentage Change in Omega-3 Fatty Acid Levels From Baseline After 24 Hours |
23.19; 70.01; 22.60; 89.12 | — |
| SECONDARY Changes in the Expression of Peripheral Blood Neutrophil Activation Markers |
31.97; 30.90; 6.723; 13.93 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 1) 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
Data sourced from ClinicalTrials.gov (NCT03347006). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.