Comparison of omega-3 fatty acid supplement formulations.

A randomised cross-over trial to compare erythrocyte membrane incorporation, acceptability and tolerability of omega-3 fatty acids in a drink carton formulation with an equivalent dose of omega-3 fatty acids in soft gelatin capsule form.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN18662143

Enrollment

Registered

2015-06-22

Start date

2015-06-01

Completion date

Unknown

Last updated

2018-12-04

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

Conditions

This is a healthy volunteer study. Nervous System Diseases

Interventions

An open label, randomised, cross-over trial in healthy volunteers aged >50 years randomised to omega-3 fatty acid (O3FA) supplementation for a period of eight weeks with either: 1. Two

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Healthy male and female subjects >50 years 2. Signed informed consent 3. Be able to understand and comply with the requirements of the study, as judged by the Investigator

Exclusion criteria

Exclusion criteria: 1. Ongoing or planned use of other O3FA or cod-liver oil supplements 2. Seafood allergy 3. Unable to provide written informed consent 4. Unable to commit to study timetable 5. Concomitant use of non-steroidal anti-inflammatory medications including aspirin 6. Current treatment for any chronic inflammatory condition or malignancy 7. Previous colonic or small bowel resection 8. Current smoker (minimum of 6 months smoking cessation) 9. Pregnancy 10. Any other condition which according to the Investigator would interfere with the study or safety of the patient in the planning and conduct of the study 11. Administration of any unlicensed or study product within 4 weeks of entry to the study or during the study

Design outcomes

Primary

Measure	Time frame
Change in erythrocyte membrane percentage content of EPA and DHA at eight weeks compared with baseline	—

Secondary

Measure	Time frame
1. Percentage erythrocyte membrane EPA and DHA content at 8 weeks. 2. Difference in erythrocyte membrane percentage content of arachidonic acid (AA) at 8 weeks compared with baseline. 3. Acceptability of and compliance with each O3FA preparation 4. Tolerability and adverse events related to each O3FA preparation 5. Change in intestinal microbiome after O3FA supplementation for eight weeks 6. Urinary prostaglandin metabolite levels following O3FA supplementation 7. Change in memory and learning functions after 8 weeks of O3FA supplementation	—

Measure

Time frame

1. Percentage erythrocyte membrane EPA and DHA content at 8 weeks. 2. Difference in erythrocyte membrane percentage content of arachidonic acid (AA) at 8 weeks compared with baseline. 3. Acceptability of and compliance with each O3FA preparation 4. Tolerability and adverse events related to each O3FA preparation 5. Change in intestinal microbiome after O3FA supplementation for eight weeks 6. Urinary prostaglandin metabolite levels following O3FA supplementation 7. Change in memory and learning functions after 8 weeks of O3FA supplementation

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 26, 2026