Clinical trial NCT03245749: Effect of Oily Fish Intake, Sex, Age, BMI, and APOE Genotype on Plasma Long Chain n-3 Fatty Acid Composition
Official title: Effect of Oily Fish Intake, Sex, Age, BMI, and APOE Genotype on Plasma Long Chain n-3 Fatty Acid Composition
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Plasma Omega-3 Status
Keywords: omega-3 status
blood lipids
Eicosapentaenoic acid (EPA)
Docosahexaenoic acid (DHA)
Lead sponsor: University of Southampton
Sponsor class: OTHER
Collaborators: name: Food Standards Agency, United Kingdom
name: Ocean Nutrition
First posted: 2017-08-10
Enrollment: 374
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals residing in Southampton, East Anglia, Glasgow and Newcastle

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Plasma long chain n-3 polyunsaturated fatty acid concentrations
timeFrame: Baseline
Secondary outcomes:
measure: APOE genotyping
timeFrame: Baseline
measure: Anthropometric measurements
timeFrame: Baseline
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: University of Glasgow
city: Newcastle upon Tyne
country: United Kingdom
facility: Newcastle University
city: Norwich
country: United Kingdom
facility: Univeristy of East Anglia
city: Reading
country: United Kingdom
facility: University of Reading
city: Southampton
country: United Kingdom
facility: University of Southampton
Study officials:
affiliation: University of Southampton
name: Philip C Calder
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.