NCT03245749

Brief Summary

The purpose of this study is to investigate the effect of habitual oily fish intake, sex, age, BMI, and APOE genotype on plasma long chain n-3 fatty acid composition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
374

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2003

Typical duration for all trials

Geographic Reach
1 country

5 active sites

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

June 1, 2003

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
11.4 years until next milestone

First Submitted

Initial submission to the registry

August 7, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 10, 2017

Completed
Last Updated

July 8, 2021

Status Verified

July 1, 2021

Enrollment Period

2.3 years

First QC Date

August 7, 2017

Last Update Submit

July 4, 2021

Conditions

Plasma Omega-3 Status

Keywords

omega-3 statusblood lipidsEicosapentaenoic acid (EPA)Docosahexaenoic acid (DHA)

Outcome Measures

Primary Outcomes (1)

  • Plasma long chain n-3 polyunsaturated fatty acid concentrations

    Concentrations of eicosapentaenoic acid (EPA), docosapentaenoic acid (DPA) and docosahexaenoic acid (DHA) in plasma phosphatidylcholine, non-esterified fatty acids, cholesteryl esters and triacylglycerols

    Baseline

Secondary Outcomes (2)

  • APOE genotyping

    Baseline

  • Anthropometric measurements

    Baseline

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Individuals residing in Southampton, East Anglia, Glasgow and Newcastle

You may not qualify if:

  • Diagnosed endocrine dysfunction including diabetes
  • Fasting glucose concentration \> 6.5 mmol/L
  • Myocardial infarction in the previous 2 years
  • The use of medication that may interfere with lipid metabolism
  • Fasting total cholesterol of \> 8.0 mmol/L
  • TG of \> 3.0 mmol/L
  • Currently following a weight loss diet
  • Taking n-3 fatty acid supplements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Glasgow

Glasgow, United Kingdom

Location

Newcastle University

Newcastle upon Tyne, United Kingdom

Location

Univeristy of East Anglia

Norwich, United Kingdom

Location

University of Reading

Reading, United Kingdom

Location

University of Southampton

Southampton, United Kingdom

Location

Related Publications (1)

  • Fisk HL, Irvine M, Miles EA, Lietz G, Mathers JC, Packard CJ, Armah CK, Kofler BM, Curtis PJ, Minihane AM, Calder PC. Association of oily fish intake, sex, age, BMI and APOE genotype with plasma long-chain n-3 fatty acid composition. Br J Nutr. 2018 Jul;120(1):23-32. doi: 10.1017/S000711451800106X. Epub 2018 May 6.

    PMID: 29729672RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood and plasma samples

Study Officials

  • Philip C Calder

    University of Southampton

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2017

First Posted

August 10, 2017

Study Start

June 1, 2003

Primary Completion

September 1, 2005

Study Completion

March 1, 2006

Last Updated

July 8, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

GB(5)