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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03245749
Other study ID # RRD7/N02/A
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2003
Est. completion date March 2006

Study information

Verified date July 2021
Source University of Southampton
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

The marine long chain n-3 polyunsaturated fatty acids (LC n-3 PUFAs) eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are beneficial to cardiovascular and cognitive health and the concentration of EPA and DHA present in blood and tissue lipids is positively correlated with these effects. As a result, national and global authorities recommend regular consumption of oily fish in order to provide approximately 500 mg EPA+DHA per day in a healthy population. However, the associations between EPA and DHA intake and blood and tissue status, and therefore physiological benefits, are highly variable and the factors influencing this heterogeneity are not well understood. This study aims to investigate the effect of habitual oily fish intake as well as sex, age, BMI, and Apolipoprotein E (APOE) genotype on LC n-3 PUFA status in plasma phosphatidylcholine, non-esterified fatty acids, cholesteryl esters and triacylglycerols in order to obtain greater knowledge of the determinants of LC n-3 PUFA status with the potential to develop more robust, and perhaps subgroup specific, recommendations for EPA and DHA intake.


Recruitment information / eligibility

Status Completed
Enrollment 374
Est. completion date March 2006
Est. primary completion date September 2005
Accepts healthy volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United Kingdom University of Glasgow Glasgow
United Kingdom Newcastle University Newcastle upon Tyne
United Kingdom Univeristy of East Anglia Norwich
United Kingdom University of Reading Reading
United Kingdom University of Southampton Southampton

Sponsors (3)

Lead Sponsor Collaborator
University of Southampton Food Standards Agency, United Kingdom, Ocean Nutrition

Country where clinical trial is conducted

United Kingdom, 

References & 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;1 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 APOE genotyping APOE genotype determined from blood sample Baseline
Secondary Anthropometric measurements Height and weight to determine BMI Baseline