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

NCT ID: NCT01692431

Last Updated: 2013-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-10-31

Brief Summary

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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

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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DHA

High fat meal containing DHA rich oil.

Group Type EXPERIMENTAL

DHA

Intervention Type DIETARY_SUPPLEMENT

High fat meal containing DHA

EPA

High fat meal containing EPA.

Group Type EXPERIMENTAL

EPA

Intervention Type DIETARY_SUPPLEMENT

High fat meal containing EPA

Control

High fat meal with no/negligable omega-3 fatty acid content.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

High fat meal containing negligible EPA/DHA content

Interventions

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EPA

High fat meal containing EPA

Intervention Type DIETARY_SUPPLEMENT

DHA

High fat meal containing DHA

Intervention Type DIETARY_SUPPLEMENT

Placebo

High fat meal containing negligible EPA/DHA content

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

In order to recruit a population at a relative risk of developing CVD of \>1.5 males aged 35-55 years, who possess one of the following risk factors for CVD will be recruited through local advertisement:

* Total cholesterol \> 6mmol/L
* High density lipoprotein cholesterol (HDLC) \< 1.0mmol/L
* Systolic blood pressure \> 140 mmHg
* Diastolic blood pressure \> 90 mmHg
* Waist circumference \> 102cm

Exclusion Criteria

Current smokers, or ex-smokers ceasing \< 3 months ago

Subjects with existing or significant past medical history of vascular disease or any medical condition likely to affect the study measures e.g. vascular disease, circulatory (i.e. Reynaud's), diabetes, systemic lupus erythematosus, hepatic, renal, digestive, haematological, neurological, cancer or thyroidal disease.

Those with known allergies to the intervention foods / commercially available supplements.

Those unprepared to adhere to dietary restrictions during the trial i.e. for 3 days preceding each assessment visit (and for a 3 day run-in period) or unwilling to comply with the assessments per protocol.

Parallel participation in another research project which involves concurrent dietary intervention and/or sampling of biological fluids/material.

Having vaccinations (excluding the flu vaccination) or antibiotics within 3 months of start of trial, and those with vaccinations scheduled for during the trial.

Taking EPA or DHA containing food / dietary supplements likely to affect the study results e.g. supplements derived from marine organisms which equate to a greater than 1 gram of EPA and DHA per daily serving. Prospective participants who are willing to cease supplementation 2 month preceding, and during, the trial will be considered on a case by case basis.

Habitual consumption of more than one portion of oily fish per week (as defined as 140g of any oil fish, including salmon, trout, mackerel, sardines, pilchards, herring, kipper, eel, whitebait, etc).

Prescribed lipid lowering, medicine affecting lipoprotein metabolism or blood blotting, hypertension, vasodilators (e.g. Viagra) or antibiotic medication.

Assessed from the clinical screening.

Unsatisfactory biochemical or haematological assessment assessed by the studies clinical advisor
Minimum Eligible Age

35 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of East Anglia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne Marie Minihane, PhD

Role: PRINCIPAL_INVESTIGATOR

University of East Anglia

Locations

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Norwich Medical School

Norwich, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Armah CK, Jackson KG, Doman I, James L, Cheghani F, Minihane AM. Fish oil fatty acids improve postprandial vascular reactivity in healthy men. Clin Sci (Lond). 2008 Jun;114(11):679-86. doi: 10.1042/CS20070277.

Reference Type BACKGROUND
PMID: 18052925 (View on PubMed)

Other Identifiers

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12/EE/011

Identifier Type: -

Identifier Source: org_study_id