Neurovascular Coupling Clinical Trial
Official title:
Efficacy Evaluation of 26 Weeks' Dietary Supplementation With DHA- and EPA-enriched Oils on Cerebral Blood Flow in Healthy Adults
| Verified date | September 2017 |
| Source | Northumbria University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 78 |
| Est. completion date | September 4, 2017 |
| Est. primary completion date | September 4, 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 25 Years to 49 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Northumbria University | Newcastle upon Tyne | Tyne and Wear |
| Lead Sponsor | Collaborator |
|---|---|
| Northumbria University | Pronova BioPharma |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Cerebral Blood Flow | Near Infrared Spectroscopy Outcomes for cerebral blood flow measurment | Participants are assessed pre and post 6 months of supplementation | |
| Secondary | Cognitive Performance | performance on numerical subtraction tasks | Participants are assessed pre and post 6 months of supplementation | |
| Secondary | Subjective Task Difficulty | participants rate how mentally challenging they find the cognitive tasks | Participants are assessed pre and post 6 months of supplementation |