The Effects of DHA- and EPA-enriched Oils on Cognitive Function and Mood
NCT ID: NCT02763514
Last Updated: 2019-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
337 participants
INTERVENTIONAL
2016-10-31
2018-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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DHA-enriched oil
3 g PronovaPure 150:500 EE EU
3 g PronovaPure 150:500 EE EU
EPA-enriched oil
3 g PronovaPure 500:200 EE EU
3 g PronovaPure 500:200 EE EU
Placebo
3 g Olive oil
3 g Placebo
Interventions
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3 g PronovaPure 150:500 EE EU
3 g PronovaPure 500:200 EE EU
3 g Placebo
Eligibility Criteria
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Inclusion Criteria
* Males and females
* Self-report of good health
Exclusion Criteria
* Habitual consumption of oily fish exceeds one fish meal per week
* 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 or may be at risk of having 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
25 Years
49 Years
ALL
Yes
Sponsors
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Pronova BioPharma
INDUSTRY
Northumbria University
OTHER
Responsible Party
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Philippa Jackson
Dr
Principal Investigators
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Philippa Jackson, PhD
Role: PRINCIPAL_INVESTIGATOR
Northumbria University
Locations
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Northumbria University
Newcastle upon Tyne, Tyne and Wear, United Kingdom
Countries
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References
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Patan MJ, Kennedy DO, Husberg C, Hustvedt SO, Calder PC, Khan J, Forster J, Jackson PA. Supplementation with oil rich in eicosapentaenoic acid, but not in docosahexaenoic acid, improves global cognitive function in healthy, young adults: results from randomized controlled trials. Am J Clin Nutr. 2021 Sep 1;114(3):914-924. doi: 10.1093/ajcn/nqab174.
Other Identifiers
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44N3
Identifier Type: -
Identifier Source: org_study_id
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