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

Not Applicable

Completed

• Conditions: Cognitive Function
• Interventions: Dietary Supplement: 3 g Placebo

• Registration Number: NCT02763514
• Lead Sponsor: Northumbria University

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 cognitive function (episodic memory, attention, working memory, executive function), subjective mood, alertness and mental fatigue after 26 weeks daily supplementation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-20
• Study First Submitted QC: 2016-05-04
• Study First Posted: 2016-05-05
• Study Start: 2016-10
• Primary Completion: 2018-11-30
• Study Completion: 2018-11-30
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-22
• Last Update Posted: 2019-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 337

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	3 g Placebo	3 g Olive oil

Primary Outcome Measures

Name	Time	Method
Episodic memory	26 weeks	An overall score for Episodic memory will be derived by calculating the average score from 6 separate standardised task outcomes (Zimmediate word recall accuracy + Zdelayed word recall accuracy + Zword recognition accuracy + Zpicture recognition accuracy - Zimmediate word recall errors - Zdelayed word recall errors)/6
Subjective fatigue	26 weeks	Subjective fatigue will be derived from the Fatigue subscale of the Profile of Mood States questionnaire

Secondary Outcome Measures

Name	Time	Method
Subjective alertness	26 weeks	Subjective alertness will be derived from an Alertness visual analogue scale presented following cognitive task performance
Subjective mental fatigue	26 weeks	Subjective mental fatigue will be derived from a Mental Fatigue visual analogue scale presented following cognitive task performance
Simple reaction time	26 weeks
Numeric Working memory	26 weeks	Accuracy (%)
Subjective confusion	26 weeks	Subjective confusion will be derived from the Confusion subscale of the Profile of Mood States questionnaire
Subjective overall mood disturbance	26 weeks	Subjective overall mood disturbance is derived from the overall score of the Profile of Mood States questionnaire
Rapid visual information processing	26 weeks	Accuracy (%)
Verbal fluency	26 weeks	Number correct
Subjective vigour	26 weeks	Subjective vigour will be derived from the Vigour subscale of the Profile of Mood States questionnaire
Subjective anger	26 weeks	Subjective anger will be derived from the Anger subscale of the Profile of Mood States questionnaire
Subjective tension	26 weeks	Subjective tension will be derived from the Tension subscale of the Profile of Mood States questionnaire
Stroop task	26 weeks	Accuracy (%)

Trial Locations

Locations (1)

Northumbria University; 🇬🇧 Newcastle upon Tyne, Tyne And Wear, United Kingdom