The Impact of Fish-oil Fatty Acids on Postprandial Vascular Reactivity
NCT ID: NCT01692431
Last Updated: 2013-10-16
Study Results
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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COMPLETED
NA
28 participants
INTERVENTIONAL
2012-09-30
2013-10-31
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
Study Groups
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DHA
High fat meal containing DHA rich oil.
DHA
High fat meal containing DHA
EPA
High fat meal containing EPA.
EPA
High fat meal containing EPA
Control
High fat meal with no/negligable omega-3 fatty acid content.
Placebo
High fat meal containing negligible EPA/DHA content
Interventions
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EPA
High fat meal containing EPA
DHA
High fat meal containing DHA
Placebo
High fat meal containing negligible EPA/DHA content
Eligibility Criteria
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Inclusion Criteria
* 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
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
35 Years
55 Years
MALE
Yes
Sponsors
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University of East Anglia
OTHER
Responsible Party
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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
Countries
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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.
Other Identifiers
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12/EE/011
Identifier Type: -
Identifier Source: org_study_id