NCT03158545

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 cerebral blood flow during a series of cognitive, mathematical subtraction tasks and subjective ratings of task difficulty 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
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

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

October 10, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 18, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2017

Completed
Last Updated

September 12, 2017

Status Verified

September 1, 2017

Enrollment Period

11 months

First QC Date

May 16, 2017

Last Update Submit

September 11, 2017

Conditions

Neurovascular Coupling

Outcome Measures

Primary Outcomes (1)

  • Cerebral Blood Flow

    Near Infrared Spectroscopy Outcomes for cerebral blood flow measurment

    Participants are assessed pre and post 6 months of supplementation

Secondary Outcomes (2)

  • Cognitive Performance

    Participants are assessed pre and post 6 months of supplementation

  • Subjective Task Difficulty

    Participants are assessed pre and post 6 months of supplementation

Study Arms (3)

Olive oil Placebo

PLACEBO COMPARATOR

3 x 1 g capsules daily Placebo: olive oil

Dietary Supplement: Olive oil Placebo

EPA-rich

ACTIVE COMPARATOR

3 x 1 g capsules daily containing EPA-enriched oil

Dietary Supplement: EPA-rich

DHA-rich

ACTIVE COMPARATOR

3 x 1 g capsules daily containing DHA-enriched oil

Dietary Supplement: DHA-rich

Interventions

Olive oil PlaceboDIETARY_SUPPLEMENT

olive oil

Olive oil Placebo
EPA-richDIETARY_SUPPLEMENT

EPA-rich omega-3 oil

EPA-rich
DHA-richDIETARY_SUPPLEMENT

DHA-rich omega-3 oil

DHA-rich

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 (see Appendix I)
  • 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
  • +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 Officials

  • Philippa Jackson, PhD

    Northumbria University

    PRINCIPAL INVESTIGATOR

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
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

May 16, 2017

First Posted

May 18, 2017

Study Start

October 10, 2016

Primary Completion

September 4, 2017

Study Completion

September 4, 2017

Last Updated

September 12, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)