26 Weeks' Dietary Supplementation With DHA- and EPA-enriched Oils on Memory Consolidation in Healthy Adults

Not Applicable

Completed

• Conditions: Memory Consolidation
• Interventions: Dietary Supplement: Olive Oil Placebo; Dietary Supplement: EPA-rich; Dietary Supplement: DHA-rich

• Registration Number: NCT03592251
• 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 overnight verbal and visual memory consolidation as well as morning alertness before and after 26 weeks of supplementation

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-01
• Study First Submitted: 2018-05-29
• Study First Submitted QC: 2018-07-09
• Study First Posted: 2018-07-19
• Primary Completion: 2018-11-30
• Study Completion: 2018-11-30
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-23
• Last Update Posted: 2019-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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 n-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
EPA-rich	Olive Oil Placebo	3 x 1 g capsules daily containing a SMEDDS formulation of an EPA-enriched oil totalling 900 mg EPA and 360 mg of DHA
Olive oil Placebo	DHA-rich	3 x 1 g capsules daily Placebo: olive oil
Olive oil Placebo	EPA-rich	3 x 1 g capsules daily Placebo: olive oil
EPA-rich	DHA-rich	3 x 1 g capsules daily containing a SMEDDS formulation of an EPA-enriched oil totalling 900 mg EPA and 360 mg of DHA
DHA-Rich	EPA-rich	3 x 1 g capsules daily containing a SMEDDS formulation of an DHA-enriched oil totalling 900 mg DHA and 270 mg of EPA
DHA-Rich	Olive Oil Placebo	3 x 1 g capsules daily containing a SMEDDS formulation of an DHA-enriched oil totalling 900 mg DHA and 270 mg of EPA

Primary Outcome Measures

Name	Time	Method
Verbal Learning task	26 months	Delayed recall accuracy
Computerised Location Learning task	26 months	Delayed recall accuracy

Secondary Outcome Measures

Name	Time	Method
Peg and Ball/Tower of London task	pre, Mid and post dose measures	Errors (number)
Simple reaction time task	26 months	reaction time speed from a simple reaction task
Computerised Location Learning task	26 months	Learning index
Verbal Learning task	26 months	Learning index
Digit vigilance task	26 months	Reaction time (ms)
Subjective Alertness	26 months	Subjective ratings of alertness upon waking on a visual analogue scale (0-100 with 100 denoting the most alert the participant has ever felt in their life)

Trial Locations

Locations (1)

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