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

NCT01692431 | Completed

• 1 other identifier: 12/EE/011
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Endopat

  EndoPat is an easy to use and rapid technique which has been validated against other clinically accepted measures of endothelial function such as Flow Mediated Dilation and Coronary Blood Flow measured by angiography alongside acetylcholine infusion. EndoPat has also been shown to correlate with multiple known CVD risk factors and to be predictive of future cardiovascular events. In addition, EndoPat will be utilised alongside oral administration of nitroglycerin in order to establish if peripheral arterial tone is altered in response to EPA or DHA in a non-Nitric Oxide dependent manner. EndoPAT produces a reactive hyperaemic index score which is indicative of the endothelial's capacity to produce NO, which itself is indicative of general endothelial function. EndoPAT will be assessed using a standardised methodology developed by Itamar Medical, which involves measuring changes in dilation in response to induced hyperaemia.

  Change from baseline at 4 hours postprandially

Secondary Outcomes (1)

• Pulse Wave Velocity

  Change from baseline at 4 hours postprandially

Study Arms (3)

DHA

EXPERIMENTAL

High fat meal containing DHA rich oil.

Dietary Supplement: DHA

EPA

EXPERIMENTAL

High fat meal containing EPA.

Dietary Supplement: EPA

Control

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

EPA DIETARY_SUPPLEMENT

High fat meal containing EPA

EPA

DHA DIETARY_SUPPLEMENT

High fat meal containing DHA

DHA

Placebo DIETARY_SUPPLEMENT

High fat meal containing negligible EPA/DHA content

Control

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of East Anglia: lead

Study Sites (1)

Norwich Medical School

Norwich, NR47TJ, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 18052925 BACKGROUND

Study Officials

• Anne Marie Minihane, PhD

  University of East Anglia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2012
• First Posted: September 25, 2012
• Study Start: September 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: October 16, 2013

Record last verified: 2013-10

Locations

GB (1)