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

Cognitive Function Clinical Trial

Official title:

Efficacy Evaluation of 26 Weeks' Dietary Supplementation With DHA- and EPA-enriched Oils on Cognitive Function and Mood in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02763514
• Other study ID #: 44N3
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: November 30, 2018

Study information

• Verified date: January 2019
• Source: Northumbria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 337
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2018
• 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

• 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

Related Conditions & MeSH terms

• Cognitive Function

Intervention

Dietary Supplement:
• 3 g PronovaPure 150:500 EE EU

• 3 g PronovaPure 500:200 EE EU

• 3 g Placebo

Locations

Country	Name	City	State
United Kingdom	Northumbria University	Newcastle upon Tyne	Tyne And Wear

Sponsors (2)

Lead Sponsor	Collaborator
Northumbria University	Pronova BioPharma

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Omega-3 index	Omega-3 index is expressed as the sum of EPA and DHA as a percentage of total red blood cell fatty acids	26 weeks
Primary	Episodic memory	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	26 weeks
Primary	Subjective fatigue	Subjective fatigue will be derived from the Fatigue subscale of the Profile of Mood States questionnaire	26 weeks
Secondary	Subjective overall mood disturbance	Subjective overall mood disturbance is derived from the overall score of the Profile of Mood States questionnaire	26 weeks
Secondary	Subjective vigour	Subjective vigour will be derived from the Vigour subscale of the Profile of Mood States questionnaire	26 weeks
Secondary	Subjective confusion	Subjective confusion will be derived from the Confusion subscale of the Profile of Mood States questionnaire	26 weeks
Secondary	Subjective anger	Subjective anger will be derived from the Anger subscale of the Profile of Mood States questionnaire	26 weeks
Secondary	Subjective tension	Subjective tension will be derived from the Tension subscale of the Profile of Mood States questionnaire	26 weeks
Secondary	Subjective alertness	Subjective alertness will be derived from an Alertness visual analogue scale presented following cognitive task performance	26 weeks
Secondary	Subjective mental fatigue	Subjective mental fatigue will be derived from a Mental Fatigue visual analogue scale presented following cognitive task performance	26 weeks
Secondary	Numeric Working memory	Reaction time (ms)	26 weeks
Secondary	Numeric Working memory	Accuracy (%)	26 weeks
Secondary	Simple reaction time		26 weeks
Secondary	Stroop task	Reaction time (ms)	26 weeks
Secondary	Stroop task	Accuracy (%)	26 weeks
Secondary	Rapid visual information processing	Reaction time (ms)	26 weeks
Secondary	Rapid visual information processing	Accuracy (%)	26 weeks
Secondary	Verbal fluency	Number correct	26 weeks