Cardiovascular Risk FactorseFAIRENCT01351324
A Study of Different Types of Fatty Acid on Risk Factors for Heart Disease
A study testing Absence or presence of fish oil in people with Cardiovascular Risk Factors, run by University of Reading at 1 site in United Kingdom.
Trial summary
Experimental elevation of non-esterified fatty acids (NEFA) impairs endothelial function and insulin sensitivity but the impact of NEFA composition is unknown. The objective was to test the effect of acute elevation of NEFA enriched with either saturated fatty acids (SFA) or SFA with long-chain n-3 polyunsaturated… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factors
- What is being tested?
- Absence or presence of fish oil
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2009to May 2010
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Either homozygous for eNOS Glu298 (wildtype)or eNOS Asp298 (variant)
Who cannot join
- Smokers
- Raised fasting blood lipids
- Taking excessive fish oil supplements (>1g EPA/DHA per day)
- Taking medication known to influence blood lipids, blood pressure or blood clotting
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Elevation of Non-esterified Fatty Acids on Endothelial Function and Insulin Sensitivity: A Comparison of Saturated and Long Chain n-3 Polyunsaturated Fatty Acids During the Postprandial Phase
Experimental elevation of non-esterified fatty acids (NEFA) impairs endothelial function and insulin sensitivity but the impact of NEFA composition is unknown.
The objective was to test the effect of acute elevation of NEFA enriched with either saturated fatty acids (SFA) or SFA with long-chain n-3 polyunsaturated fatty acids (LC n-3 PUFA) on postprandial vascular function measured via flow-mediated dilatation (FMD), laser Doppler iontophoresis (LDI) and digital volume pulse (DVP), followed by a hyperinsulinaemic-euglycaemic clamp as a measure of whole body insulin sensitivity.
Read the detailed description
To investigate potential diet-gene interactions, potential subjects (n=370) were prospectively genotyped for the eNOS Glu298Asp polymorphism, of which 35 were Asp298 and 150 were Glu298 homozygotes. Three subjects in the Asp298 group were unable to participate, two were unsuitable according to selection criteria and one subject subsequently withdrew from the study. Subjects homozygous for Asp298 (n=29) and Glu298 (n=30) were therefore selected, balanced for gender, age and BMI.
- Conditions
- Cardiovascular Risk Factors
- Being tested
- Absence or presence of fish oil
- Keywords
- Endothelial function, Non-esterified fatty acids, Insulin sensitivity
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Absence or presence of fish oilDietary supplement
Oral dose of saturated fat with or without fish oil and a heparin infusion
| Study group | Role | What they receive |
|---|---|---|
| SFA | Experimental | Oral dose of palmitic acid (SFA) given as a chocolate-flavoured drink every 30 min (0-390 min) with a continuous infusion of heparin (60-390 min). Receives: Dietary Supplement: Absence or presence of fish oil |
| SFA + LC n-3 PUFA | Experimental | Oral dose of palmitic acid and DHA-rich fish oil (SFA + LC n-3 PUFA) given as a chocolate-flavoured drink every 30 min (0-390 min) together with a continuous infusion of heparin (60-390 min). Receives: Dietary Supplement: Absence or presence of fish oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow-mediated dilatation
Measured: Change from baseline to 240 min
Flow-mediated dilatation
Measured: Change from 240 min to 390 min
Secondary outcomes (8)
Digital volume pulse
Measured: Change from baseline to 240 min
Laser Doppler iontophoresis
Measured: Change from baseline to 240 min
Insulin sensitivity
Measured: 390 min
NEFA composition
Measured: Change from baseline to 240 min
Circulating endothelial function markers
Measured: Change from baseline to 240 min
Digital volume pulse
Measured: Change from 240 min to 390 min
Laser Doppler iontophoresis
Measured: Change from 240 min to 390 min
Circulating endothelial markers
Measured: Change from 240 min to 390 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2011 (estimated)
- Study startMar 2009
- Primary completionJan 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk FactorsStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Collaborators
- Biotechnology and Biological Sciences Research Council, Unilever R&D, Foundation for Research Science and Technology (New Zealand)
- Investigators
- Christine M Williams, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01351324
- Sponsor's protocol ID
- CMW-BB/E021816/1
- Acronym
- eFAIRE
- Status last verified
- Apr 2011
- First submitted
- 6 May 2011
- Last updated
- 10 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Newens KJ, Thompson AK, Jackson KG, Williams CM. Endothelial function and insulin sensitivity during acute non-esterified fatty acid elevation: Effects of fat composition and gender. Nutr Metab Cardiovasc Dis. 2015 Jun;25(6):575-81. doi: 10.1016/j.numecd.2015.03.004. Epub 2015 Mar 14.
PubMed 25921849Newens KJ, Thompson AK, Jackson KG, Wright J, Williams CM. DHA-rich fish oil reverses the detrimental effects of saturated fatty acids on postprandial vascular reactivity. Am J Clin Nutr. 2011 Sep;94(3):742-8. doi: 10.3945/ajcn.110.009233. Epub 2011 Aug 10.
PubMed 21831993
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Elevation of Non-esterified Fatty Acids on Endothelial Function and Insulin Sensitivity: A Comparison of Saturated and Long Chain n-3 Polyunsaturated Fatty Acids During the Postprandial Phase
- ClinicalTrials.gov ID
- NCT01351324
- Acronym / sponsor ID
- eFAIRE / CMW-BB/E021816/1
- Conditions
- Cardiovascular Risk Factors
- Keywords
- Endothelial function, Non-esterified fatty acids, Insulin sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Collaborators
- Biotechnology and Biological Sciences Research Council, Unilever R&D, Foundation for Research Science and Technology (New Zealand)
- Study start
- Mar 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 10 May 2011 (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.
Experimental elevation of non-esterified fatty acids (NEFA) impairs endothelial function and insulin sensitivity but the impact of NEFA composition is unknown.
The objective was to test the effect of acute elevation of NEFA enriched with either saturated fatty acids (SFA) or SFA with long-chain n-3 polyunsaturated fatty acids (LC n-3 PUFA) on postprandial vascular function measured via flow-mediated dilatation (FMD), laser Doppler iontophoresis (LDI) and digital volume pulse (DVP), followed by a hyperinsulinaemic-euglycaemic clamp as a measure of whole body insulin sensitivity.
Detailed description
To investigate potential diet-gene interactions, potential subjects (n=370) were prospectively genotyped for the eNOS Glu298Asp polymorphism, of which 35 were Asp298 and 150 were Glu298 homozygotes. Three subjects in the Asp298 group were unable to participate, two were unsuitable according to selection criteria and one subject subsequently withdrew from the study. Subjects homozygous for Asp298 (n=29) and Glu298 (n=30) were therefore selected, balanced for gender, age and BMI.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SFA | Experimental | Dietary Supplement: Absence or presence of fish oilOral dose of palmitic acid (SFA) given as a chocolate-flavoured drink every 30 min (0-390 min) with a continuous infusion of heparin (60-390 min). |
| SFA + LC n-3 PUFA | Experimental | Dietary Supplement: Absence or presence of fish oilOral dose of palmitic acid and DHA-rich fish oil (SFA + LC n-3 PUFA) given as a chocolate-flavoured drink every 30 min (0-390 min) together with a continuous infusion of heparin (60-390 min). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy
- Either homozygous for eNOS Glu298 (wildtype)or eNOS Asp298 (variant)
Key exclusion criteria (4 listed)
- Smokers
- Raised fasting blood lipids
- Taking excessive fish oil supplements (>1g EPA/DHA per day)
- Taking medication known to influence blood lipids, blood pressure or blood clotting
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 |
|---|---|---|
| Absence or presence of fish oilOral dose of saturated fat with or without fish oil and a heparin infusion | Dietary supplement | SFA, SFA + LC n-3 PUFA |
Primary outcome
Flow-mediated dilatation
Time frame: Change from baseline to 240 min
Flow-mediated dilatation
Time frame: Change from 240 min to 390 min
8 secondary outcomes
Digital volume pulse
Time frame: Change from baseline to 240 min
Laser Doppler iontophoresis
Time frame: Change from baseline to 240 min
Insulin sensitivity
Time frame: 390 min
NEFA composition
Time frame: Change from baseline to 240 min
Circulating endothelial function markers
Time frame: Change from baseline to 240 min
Digital volume pulse
Time frame: Change from 240 min to 390 min
Laser Doppler iontophoresis
Time frame: Change from 240 min to 390 min
Circulating endothelial markers
Time frame: Change from 240 min to 390 min
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 10 May 2011.
- Derived from this study: PubMed 25921849Newens KJ, Thompson AK, Jackson KG, Williams CM. Endothelial function and insulin sensitivity during acute non-esterified fatty acid elevation: Effects of fat composition and gender. Nutr Metab Cardiovasc Dis. 2015 Jun;25(6):575-81. doi: 10.1016/j.numecd.2015.03.004. Epub 2015 Mar 14.
- Derived from this study: PubMed 21831993Newens KJ, Thompson AK, Jackson KG, Wright J, Williams CM. DHA-rich fish oil reverses the detrimental effects of saturated fatty acids on postprandial vascular reactivity. Am J Clin Nutr. 2011 Sep;94(3):742-8. doi: 10.3945/ajcn.110.009233. Epub 2011 Aug 10.
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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.
Christine M Williams principal investigator
University of Reading
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Absence or presence of fish oil in people with Cardiovascular Risk Factors, run by University of Reading 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 2 inclusion and 4 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 10 May 2011. 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. 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?
Flow-mediated dilatation (time frame: Change from baseline to 240 min). The study lists 2 primary outcomes in all. 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 NCT01351324, which also lists 2 linked publications.
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 10 May 2011.