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Incorporation of omega-3 fatty acids in healthy humans

Incorporation of omega-3 fatty acids in healthy humans following oral dosing of dietary supplements

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN96459690
Enrollment
80
Registered
2017-02-14
Start date
2016-04-18
Completion date
Unknown
Last updated
2023-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Omega-3 fatty acid supplementation Not Applicable

Interventions

Patients are manually randomised by the hospital research pharmacist to one of four groups: 1. Omega-3 ethyl esters providing 230 mg EPA + 190 mg DHA 2. SMEDDS Omega-3

Sponsors

Pronova BioPharma
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Healthy males and females 2. Age 18 to 65 years 3. Body mass index 20 to 35 kg/m2 4. Not consuming fish oil or similar supplements 5. Not eating more than one oily fish meal per week 6. Willing to adhere to the study protocol 7. Being able to provide written informed consent 8. Omega-3 index (EPA+DHA in red blood cells_ < 6.5 at screening

Exclusion criteria

Exclusion criteria: 1. Being diabetic (type 1 or type 2) 2. Being vegetarian or vegan and unwilling to consume capsules with a beef gelatine coating 3. Use of prescribed medicine to control inflammation 4. Smokers 5. Chronic gastrointestinal problems (e.g. IBD, IBS, celiac disease, cancer) 6. Allergic to fish 7. Allergic to soybean 8. Participation in another clinical trial (currently or in the 12 weeks prior to study entry) 9. Pregnancy or lactation 10. Blood donations during 3 months prior to or during the study period 11. Omega-3 index (EPA+DHA in red blood cells > 6.5 at screening

Design outcomes

Primary

MeasureTime frame
Concentration of EPA and DHA in red blood cells, measured by gas chromatography at baseline, 1, 4 and 12 weeks

Secondary

MeasureTime frame
Concentration of EPA and DHA in plasma and white blood cells, measured by gas chromatography at baseline, 1, 4 and 12 weeks

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 5, 2026