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

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

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

Study Overview

• Status: Completed
• Conditions: Memory Consolidation
• Intervention / Treatment: Dietary supplement: EPA-rich; Dietary supplement: DHA-rich; Dietary supplement: Olive Oil Placebo

• Study Type: Interventional
• Enrollment (Actual): 168
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Tyne And Wear
    • Newcastle upon Tyne, Tyne And Wear, United Kingdom, NE1 8ST
      • Northumbria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 49 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Olive oil Placebo; 3 x 1 g capsules daily Placebo: olive oil	Dietary supplement: EPA-rich; 6 months placebo supplementation; Dietary supplement: DHA-rich; 6 months placebo supplementation
Active Comparator: EPA-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	Dietary supplement: DHA-rich; 6 months placebo supplementation; Dietary supplement: Olive Oil Placebo; 6 months placebo supplementation
Active Comparator: DHA-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	Dietary supplement: EPA-rich; 6 months placebo supplementation; Dietary supplement: Olive Oil Placebo; 6 months placebo supplementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Computerised Location Learning task	Delayed recall accuracy	26 months
Verbal Learning task	Delayed recall accuracy	26 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Computerised Location Learning task	Learning index	26 months
Verbal Learning task	Learning index	26 months
Peg and Ball/Tower of London task	Planning time (ms)	pre, Mid and post dose measures
Peg and Ball/Tower of London task	Completion time (ms)	pre, Mid and post dose measures
Peg and Ball/Tower of London task	Errors (number)	pre, Mid and post dose measures
Simple reaction time task	reaction time speed from a simple reaction task	26 months
Digit vigilance task	accuracy (%)	26 months
Digit vigilance task	Reaction time (ms)	26 months
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

Collaborators and Investigators

• Sponsor: Northumbria University
• Collaborators: BASF

Publications and helpful links

General Publications

• Patan MJ, Kennedy DO, Husberg C, Hustvedt SO, Calder PC, Khan J, Forster J, Jackson PA. Supplementation with oil rich in eicosapentaenoic acid, but not in docosahexaenoic acid, improves global cognitive function in healthy, young adults: results from randomized controlled trials. Am J Clin Nutr. 2021 Sep 1;114(3):914-924. doi: 10.1093/ajcn/nqab174.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): November 30, 2018
• Study Completion (Actual): November 30, 2018

Study Registration Dates

• First Submitted: May 29, 2018
• First Submitted That Met QC Criteria: July 9, 2018
• First Posted (Actual): July 19, 2018

Study Record Updates

• Last Update Posted (Actual): January 24, 2019
• Last Update Submitted That Met QC Criteria: January 23, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 44N6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No