NCT03592251

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 19, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

January 24, 2019

Status Verified

January 1, 2019

Enrollment Period

1.3 years

First QC Date

May 29, 2018

Last Update Submit

January 23, 2019

Conditions

Memory Consolidation

Outcome Measures

Primary Outcomes (2)

  • Computerised Location Learning task

    Delayed recall accuracy

    26 months

  • Verbal Learning task

    Delayed recall accuracy

    26 months

Secondary Outcomes (9)

  • Computerised Location Learning task

    26 months

  • Verbal Learning task

    26 months

  • Peg and Ball/Tower of London task

    pre, Mid and post dose measures

  • Peg and Ball/Tower of London task

    pre, Mid and post dose measures

  • Peg and Ball/Tower of London task

    pre, Mid and post dose measures

  • +4 more secondary outcomes

Study Arms (3)

Olive oil Placebo

PLACEBO COMPARATOR

3 x 1 g capsules daily Placebo: olive oil

Dietary Supplement: EPA-richDietary Supplement: DHA-rich

EPA-rich

ACTIVE COMPARATOR

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: Olive Oil PlaceboDietary Supplement: DHA-rich

DHA-Rich

ACTIVE COMPARATOR

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: Olive Oil PlaceboDietary Supplement: EPA-rich

Interventions

Olive Oil PlaceboDIETARY_SUPPLEMENT

6 months placebo supplementation

DHA-RichEPA-rich
EPA-richDIETARY_SUPPLEMENT

6 months placebo supplementation

DHA-RichOlive oil Placebo
DHA-richDIETARY_SUPPLEMENT

6 months placebo supplementation

EPA-richOlive oil Placebo

Eligibility Criteria

Age25 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 25 to 49 years inclusive
  • Males and females
  • Self-report of good health

You may not qualify if:

  • 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
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northumbria University

Newcastle upon Tyne, Tyne and Wear, NE1 8ST, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 34113957DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2018

First Posted

July 19, 2018

Study Start

August 1, 2017

Primary Completion

November 30, 2018

Study Completion

November 30, 2018

Last Updated

January 24, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)