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

Memory Consolidation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03592251
• Other study ID #: 44N6
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• 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 overnight verbal and visual memory consolidation as well as morning alertness before and after 26 weeks of supplementation

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• 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 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

Related Conditions & MeSH terms

• Memory Consolidation

Intervention

Dietary Supplement:
• Olive Oil Placebo
6 months placebo supplementation
• EPA-rich
6 months placebo supplementation
• DHA-rich
6 months placebo supplementation

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Northumbria University	BASF

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Computerised Location Learning task	Delayed recall accuracy	26 months
Primary	Verbal Learning task	Delayed recall accuracy	26 months
Secondary	Computerised Location Learning task	Learning index	26 months
Secondary	Verbal Learning task	Learning index	26 months
Secondary	Peg and Ball/Tower of London task	Planning time (ms)	pre, Mid and post dose measures
Secondary	Peg and Ball/Tower of London task	Completion time (ms)	pre, Mid and post dose measures
Secondary	Peg and Ball/Tower of London task	Errors (number)	pre, Mid and post dose measures
Secondary	Simple reaction time task	reaction time speed from a simple reaction task	26 months
Secondary	Digit vigilance task	accuracy (%)	26 months
Secondary	Digit vigilance task	Reaction time (ms)	26 months
Secondary	Subjective Alertness	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)	26 months