Cardiovascular Physiological PhenomenaFOFANCT01692431
The Impact of Fish-oil Fatty Acids on Postprandial Vascular Reactivity
A study testing EPA and DHA in people with Cardiovascular Physiological Phenomena and Endothelial Nitric Oxide Synthase, run by University of East Anglia at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Physiological Phenomena, Endothelial Nitric Oxide Synthase, Eicosapentaenoic Acid
- What is being tested?
- EPA and DHA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2012to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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)
- Being tested
- EPA, DHA, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPADietary supplement
High fat meal containing EPA
DHADietary supplement
High fat meal containing DHA
PlaceboDietary supplement
High fat meal containing negligible EPA/DHA content
| Study group | Role | What they receive |
|---|---|---|
| DHA | Experimental | High fat meal containing DHA rich oil. Receives: Dietary Supplement: DHA |
| EPA | Experimental | High fat meal containing EPA. Receives: Dietary Supplement: EPA |
| Control | Placebo comparator | High fat meal with no/negligable omega-3 fatty acid content. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline at 4 hours postprandially
Secondary outcomes (1)
Pulse Wave Velocity
Pulse Wave Velocity (PWV) analysis will also be utilised in order to measure arterial stiffness. PWV analysis will allow several non-invasive measurements to be taken simultaneously including PWV, which is an established index of arterial stiffness, and augmentation index, an indirect measure of arterial stiffness which is dependent on wave-reflections and independent of pulse pressure. PWV and associated measures will be measured using methodology developed by Skidmore medical. PWV is measured in m/sec while augmentation index is measured as a % of augmentation (of central aortic pressure by a reflected pulse wave).
Measured: Change from baseline at 4 hours postprandially
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Physiological PhenomenaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of East Anglia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Marie Minihane, PhD, Principal investigator, University of East Anglia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01692431
- Sponsor's protocol ID
- 12/EE/011
- Acronym
- FOFA
- Status last verified
- Oct 2013
- First submitted
- 17 Sep 2012
- Last updated
- 16 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18052925
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Fish-oil Fatty Acids on Postprandial Vascular Reactivity
- ClinicalTrials.gov ID
- NCT01692431
- Acronym / sponsor ID
- FOFA / 12/EE/011
- Conditions
- Cardiovascular Physiological Phenomena, Endothelial Nitric Oxide Synthase, Eicosapentaenoic Acid, Docosahexaenoic Acid (All-Z Isomer)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of East AngliaUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 25 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DHA | Experimental | Dietary Supplement: DHAHigh fat meal containing DHA rich oil. |
| EPA | Experimental | Dietary Supplement: EPAHigh fat meal containing EPA. |
| Control | Placebo comparator | Dietary Supplement: PlaceboHigh fat meal with no/negligable omega-3 fatty acid content. |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EPAHigh fat meal containing EPA | Dietary supplement | EPA |
| DHAHigh fat meal containing DHA | Dietary supplement | DHA |
| PlaceboHigh fat meal containing negligible EPA/DHA content | Dietary supplement | Control |
Primary outcome
Endopat
Time frame: Change from baseline at 4 hours postprandially
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.
1 secondary outcome
Pulse Wave Velocity
Time frame: Change from baseline at 4 hours postprandially
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2013.
- Background: PubMed 18052925Armah 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Marie Minihane, PhD principal investigator
University of East Anglia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EPA and DHA in people with Cardiovascular Physiological Phenomena and Endothelial Nitric Oxide Synthase, run by University of East Anglia at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endopat (time frame: Change from baseline at 4 hours postprandially). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01692431, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2013.