NCT01692431

The Impact of Fish-oil Fatty Acids on Postprandial Vascular Reactivity

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: University of East Anglia · Academic / Other
• Sex: Male
• Age: 35 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The primary aim of this study is to determine the impact of individual fish oil fatty acids on vascular reactivity and to identify underlying physiological and molecular mechanism of any observed effects. In addition response to intervention according to genotype will be determined retrospectively.

Detailed description

A loss of vascular reactivity and increased vascular tone is being increasingly recognised as a significant cardiovascular disease (CVD) risk factor and highly predictive of future CVD events. A previous study by our group has shown the inclusion of a fish oil mixture administered alongside a high fat meal preserves postprandial vascular function in healthy men \[1\]. In this three arm, placebo controlled cross over study, the impact of individual fatty acids contained within fish-oil on postprandial vascular reactivity (measured at 4 hour post test meal) will be assessed for the first time. Clinical measurements of vascular function which correlate with CVD risk factors and are predictive of future CVD events will be undertaken in order to assess any potentially beneficial effects. In addition plasma samples will be taken at 0 and 4 hours to determine the change in concentration of modulators of vascular tone. Accordingly, our nutrients of interest which will be administered in the intervention arms of the study, will be present in this lipoprotein rich fraction. By exposing cells in culture to these EPA- and DHA-enriched lipoproteins, mechanisms underlying the vascular response in our human volunteers will be investigated. Finally we will measure the plasma fatty acid profile to confirm that circulating concentrations of EPA and DHA are increasing postprandially according to intake. As it is now recognised that genetic variation, in addition to being an important determinant of the risk of all known chronic diseases, plays a large part in determining an individual's response to dietary change, DNA will be extracted from whole blood taken at the clinical screening and stored for subsequent genotyping for variants likely to be important in the regulation of EPA and DHA metabolism and vascular tone. Although the current study will not be fully powered to generate definite conclusion regarding genotype\*diet interactions, it will serve to generate pilot data for future studies.

Conditions

• Cardiovascular Physiological Phenomena
• Endothelial Nitric Oxide Synthase
• Eicosapentaenoic Acid
• Docosahexaenoic Acid (All-Z Isomer)

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	EPA	High fat meal containing EPA
DIETARY_SUPPLEMENT	DHA	High fat meal containing DHA
DIETARY_SUPPLEMENT	Placebo	High fat meal containing negligible EPA/DHA content

Timeline

• Start date: 2012-09-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2012-09-25
• Last updated: 2013-10-16

Locations

1 site across 1 country: United Kingdom