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

Study Overview
=================
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.

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

Conditions
-----------------
Cognitive Function

Intervention / Treatment
-----------------
* Dietary Supplement: 3 g PronovaPure 150:500 EE EU
* Dietary Supplement: 3 g PronovaPure 500:200 EE EU
* Dietary Supplement: 3 g Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 49 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DHA-enriched oil<br>3 g PronovaPure 150:500 EE EU | Dietary Supplement: 3 g PronovaPure 150:500 EE EU<br> <br> |
| Active Comparator: EPA-enriched oil<br>3 g PronovaPure 500:200 EE EU | Dietary Supplement: 3 g PronovaPure 500:200 EE EU<br> <br> |
| Placebo Comparator: Placebo<br>3 g Olive oil | Dietary Supplement: 3 g Placebo<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Subjective fatigue | Subjective fatigue will be derived from the Fatigue subscale of the Profile of Mood States questionnaire | 26 weeks | 

Secondary Outcome Measures

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