The Effects of DHA- and EPA-enriched Oils on Cognitive Function and Mood

NCT ID: NCT02763514

Last Updated: 2019-01-24

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

337 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-11-30

Brief Summary

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The purpose of this study is to investigate the effects of EPA- and DHA-enriched omega-3 polyunsaturated fatty acid dietary supplements on cognitive function (episodic memory, attention, working memory, executive function), subjective mood, alertness and mental fatigue after 26 weeks daily supplementation.

Detailed Description

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Conditions

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Cognitive Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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DHA-enriched oil

3 g PronovaPure 150:500 EE EU

Group Type ACTIVE_COMPARATOR

3 g PronovaPure 150:500 EE EU

Intervention Type DIETARY_SUPPLEMENT

EPA-enriched oil

3 g PronovaPure 500:200 EE EU

Group Type ACTIVE_COMPARATOR

3 g PronovaPure 500:200 EE EU

Intervention Type DIETARY_SUPPLEMENT

Placebo

3 g Olive oil

Group Type PLACEBO_COMPARATOR

3 g Placebo

Intervention Type DIETARY_SUPPLEMENT

Interventions

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3 g PronovaPure 150:500 EE EU

Intervention Type DIETARY_SUPPLEMENT

3 g PronovaPure 500:200 EE EU

Intervention Type DIETARY_SUPPLEMENT

3 g Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
* 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
Minimum Eligible Age

25 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pronova BioPharma

INDUSTRY

Sponsor Role collaborator

Northumbria University

OTHER

Sponsor Role lead

Responsible Party

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Philippa Jackson

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United Kingdom

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.

Reference Type DERIVED
PMID: 34113957 (View on PubMed)

Other Identifiers

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44N3

Identifier Type: -

Identifier Source: org_study_id

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