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26 Weeks' Dietary Supplementation With DHA- and EPA-enriched Oils on Cerebral Blood Flow in Healthy Adults

Efficacy Evaluation of 26 Weeks' Dietary Supplementation With DHA- and EPA-enriched Oils on Cerebral Blood Flow in Healthy Adults

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03158545
Enrollment
78
Registered
2017-05-18
Start date
2016-10-10
Completion date
2017-09-04
Last updated
2017-09-12

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

Conditions

Neurovascular Coupling

Brief summary

The purpose of this study is to investigate the effects of EPA- and DHA-enriched omega-3 polyunsaturated fatty acid dietary supplements on cerebral blood flow during a series of cognitive, mathematical subtraction tasks and subjective ratings of task difficulty before and after 26 weeks of supplementation

Interventions

DIETARY_SUPPLEMENTOlive oil Placebo

olive oil

DIETARY_SUPPLEMENTEPA-rich

EPA-rich omega-3 oil

DIETARY_SUPPLEMENTDHA-rich

DHA-rich omega-3 oil

Sponsors

Pronova BioPharma
CollaboratorINDUSTRY
Northumbria University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
25 Years to 49 Years
Healthy volunteers
Yes

Inclusion criteria

* Aged 25 to 49 years inclusive * Males and females * Self-report of good health

Exclusion criteria

* English is not first language (some of the cognitive tasks have only been validated in native English speakers) * Habitual consumption of oily fish exceeds one fish meal per week (see Appendix I) * Habitual consumption of omega-3 dietary supplements in the previous 6 months * Habitual use of dietary supplements within the last month (defined as more than 3 consecutive days or 4 days in total; some supplements that do not impact upon cognitive function e.g. garlic, protein, calcium are allowed. Please check with the research team if you are unsure) * Are a smoker or consume any nicotine replacement products (e.g. chewing gum, e-cigarettes) * Food allergies or sensitivities to any of the ingredients contained in the investigational product or any other foodstuff * Pregnant, trying to get pregnant or breast feeding * Body Mass Index outside of the range 18-35 kg/m2 * High blood pressure (systolic over 159 mm Hg or diastolic over 99 mm Hg) * Currently taking blood pressure medication * Currently taking blood thinning medication (e.g. aspirin, warfarin, heparin) * Have a respiratory disorder that requires regular medication (Note: participants with asthma who only take their medication occasionally/as required are eligible for this study) * Have frequent migraines that require medication (more than or equal to 1 per month) * History or current diagnosis of drug/alcohol abuse * History of kidney or liver disease, or other severe diseases of the gastrointestinal tract (e.g. iron accumulation, iron utilization disorders, hypercalcaemia, hypercalcaemia), that are likely to interfere with metabolism/absorption/secretion of the product under investigation * History of neurological or psychiatric illness (excluding depressive illness and anxiety) * History of head trauma * Sleep disturbances and/or are taking sleep aid medication * Blood disorders (e.g. anaemia, haemophilia, thrombocytosis) * Diagnosis of type I or type II diabetes * Heart disorder, or vascular illness * Current diagnosis of depression and/or anxiety * Over- or under-active thyroid * Chronic gastrointestinal problems (e.g. Inflammatory Bowel Disease, Irritable Bowel Syndrome, celiac disease) * Any known active infections * Diagnosed with syphilis, hepatitis, the Human T - lymphotropic virus or the Human Immunodeficiency Virus * Current or past breast cancer diagnosis and/or a mastectomy * Health condition that would prevent fulfilment of the study requirements * Currently participating in or in the past 4 weeks participated in other clinical or nutrition intervention studies

Design outcomes

Primary

MeasureTime frameDescription
Cerebral Blood FlowParticipants are assessed pre and post 6 months of supplementationNear Infrared Spectroscopy Outcomes for cerebral blood flow measurment

Secondary

MeasureTime frameDescription
Cognitive PerformanceParticipants are assessed pre and post 6 months of supplementationperformance on numerical subtraction tasks
Subjective Task DifficultyParticipants are assessed pre and post 6 months of supplementationparticipants rate how mentally challenging they find the cognitive tasks

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026