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HealthyNCT01735357

Differential Effects of Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) on Platelet, Endothelial and Vascular Function

A study testing EPA-rich triacylglycerol oil and DHA-rich triacylglycerol oil in people with Healthy, run by King's College London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study was to determine whether supplementation with oils enriched with long chain n-3 PUFA, either EPA or DHA, had a differential effect on platelet, endothelial and vascular function. Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
EPA-rich triacylglycerol oil and DHA-rich triacylglycerol oil
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
1 siteUnited Kingdom
Study dates
Jun 2009to Apr 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 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy males
  • No smokers
  • Aged 18-45y old
  • Able to understand the information sheet and comply with all the trial procedures
  • Having given written consent to take part in the study prior to participation.

Who cannot join

  • Reported history of CVD (myocardial infarction, angina, venous thrombosis, stroke, dyslipidemia), diabetes (or fasting glucose ≥ 6.1 mmol/L), cancer, kidney, liver or bowel disease.
  • Presence of gastrointestinal disorder or use of drug, which is likely to alter gastrointestinal motility or nutrient absorption.
  • Current smokers; history of substance abuse or alcoholism (previous weekly alcohol intake >60 units/week); current self-reported weekly alcohol intake exceeding 28 units
  • Recent use of hypolipidaemic, antihypertensive, antiplatelet or antithrombotic mediations
  • Platelet count above or below the normal range or any history indicative of a congenital or acquired platelet or haemostatic defect.
  • Allergy or intolerance to any component of study capsules
Show all 11Show fewer
  • Unwilling to restrict consumption of any source of fish oil for the length of the study
  • Subjects reporting consumption of >1 portion oily fish per week
  • Weight change of >3 kg in preceding 2 months; BMI <18 and >32 kg/m2
  • Blood pressure>160/90 mmHg
  • Fasting blood cholesterol > 6.5 mmol/L; fasting triacylglycerol concentrations > 2.0 mmol/L

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Diabetes & Nutritional Sciences Division, King's College London

    London, SE1 9NH

Other trials in United Kingdom

About this study

Official title: Investigation Into Incorporation of (n-3) Polyunsaturated Fatty Acids Into Erythrocyte Membranes and Clearance, and Effects on Platelet Function, Arterial Function and Endothelial Repair

The purpose of this study was to determine whether supplementation with oils enriched with long chain n-3 PUFA, either EPA or DHA, had a differential effect on platelet, endothelial and vascular function.

Read the detailed description

Relatively few studies have made a head-to-head comparison of DHA (22:6n-3) with EPA (20:5n-3). The understanding of this differential effect may be of great interest in populations with low EPA intake such as vegetarians, who may choose to supplement their dietary intake of long-chain n-3 PUFA in the form of DHA-rich algal oil.

This study aimed to investigate the effect of supplementation with oils rich in either EPA or DHA (3g/day, 6 weeks) in healthy young males on platelet, endothelial and vascular function, as well as other CVD risk factors. The primary outcomes were platelet monocyte aggregates and endothelial progenitor cells - novel markers of platelet and endothelial function, measured by flow cytometry, Secondary outcomes included capillary density, measured by capillaroscopy to assess changes in microvascular function, pulse wave analysis, digital volume pulse and ambulatory blood pressure. Other secondary outcomes included lipid profiles (TAG, cholesterol, NEFA), glycaemic control (HOMA, QUICKI) and oxidative stress (isoprostane). The omega-3 index (erythrocyte EPA+DHA) was used as a marker of compliance.

Conditions
Healthy
Being tested
EPA-rich triacylglycerol oil, Placebo - olive oil (BP specification), DHA-rich triacylglycerol oil
Keywords
Eicosapentaenoic acid, Docosahexaenoic acid, Cardiovascular risk, Platelet function, Endothelial function, Vascular function, young males

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EPA-rich triacylglycerol oilDietary supplement

  • Placebo - olive oil (BP specification)Dietary supplement

  • DHA-rich triacylglycerol oilDietary supplement

Study groups in NCT01735357
Study groupRoleWhat they receive
Olive oil (BP specification)Placebo comparator5g per day
Receives: Dietary Supplement: Placebo - olive oil (BP specification)
DHA-rich oilExperimentalFish oil supplement (total = 5g/day) providing 3.1g/day of DHA triacylglycerol, blended with olive oil
Receives: Dietary Supplement: DHA-rich triacylglycerol oil
EPA-rich oilExperimentalFish oil supplement (total = 5g/day) providing 2.9g/day of EPA triacylglycerol, blended with olive oil
Receives: Dietary Supplement: EPA-rich triacylglycerol oil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Platelet Monocyte Aggregates (PMA)

    The endothelium plays a vital role in the regulation of blood flow, thrombosis and inflammation. Endothelium-derived anti-adhesive and anti-aggregant substances, including prostacyclin and nitric oxide, are known to inhibit platelet activation. Endothelial dysfunction or vessel wall injury lead to the activation of platelets, of which platelet-monocyte-aggregates (PMA) are a sensitive marker, and were shown to inversely correlate with markers of EF in patients with stable CHD. The measurement of PMA by flow cytometry is a method which reduces ex vivo platelet activation to its minimum and is believed to represent platelet activation in vivo.

    Measured: 6 weeks

  2. Endothelial Progenitor Cell (EPC) counts

    EPCs are a subgroup of circulating progenitor cells that are recruited from the bone marrow to repair the injured vasculature. They have been associated with a reduced CVD risk and may serve as markers of endothelial function because they represent a greater capacity for the endothelium to repair itself. Two populations of EPCs were measured by flow cytometry, described as 'early EPC' (KDR+/CD34+/CD133+) and 'late EPCs' (KDR+/CD34+/CD31+).

    Measured: 6 weeks

Secondary outcomes (17)

  1. Capillary density

    Capillary rarefaction has been associated to CVD risk factors such as hypertension, smoking and obesity. The cutaneous circulation has emerged as an accessible and representative vascular bed to look at microvascular dysfunction. Capillary density was measured by a Capiscope (kk technologies)

    Measured: 6 weeks

  2. Arterial stiffness

    Pulse wave analysis (PWA) was used to measure indices of arterial stiffness, including peripheral and central augmentation index, as well as central systolic and diastolic blood pressure. Digital volume pulse (DVP) was used to measure reflection and stiffness indices.

    Measured: 6 weeks

  3. Blood Pressure (BP) and Heart Rate (HR)

    Resting HR and BP were measured in the seated and supine position after 15 minute rest, on the days of both baseline and endpoint visits. In addition, ambulatory BP and HR (24h, daytime, nighttime) was measured 2-3 days prior to each visit.

    Measured: 6 weeks

  4. Plasma isoprostane concentrations

    8-iso-prostaglandin-F2α (8-IsoP-F2α), a prostaglandin F2-like compound biosynthesized nonenzymatically by a free-radical oxygenation of arachidonic acid, was measured in plasma in order to assess oxidative stress.

    Measured: 6 weeks

  5. Plasma Nitrate and Nitrites (NOx) concentrations

    Plasma NOx was measured as a circulating marker of endothelial function.

    Measured: 6 weeks

  6. Serum total cholesterol concentration

    Measured: 6 weeks

  7. Serum Triacylglycerol concentrations

    Measured: 6 weeks

  8. Serum high density lipoprotein concentration

    Measured: 6 weeks

  9. Serum low density lipoprotein concentration

    Measured: 6 weeks

  10. Serum non esterified fatty acids (NEFA) concentration

    Measured: 6 weeks

  11. Serum Apolipoprotein B concentration

    Measured: 6 weeks

  12. Plasma glucose concentration

    Measured: 6 weeks

  13. Plasma insulin concentration

    Measured: 6 weeks

  14. Serum adiponectin concentration

    Measured: 6 weeks

  15. Serum resistin concentration

    Measured: 6 weeks

  16. Erythrocyte phospholipid fatty acid profiles

    The EPA and DHA content of erythrocyte lipids were used as a marker of compliance.

    Measured: 6 weeks

  17. Fatty acid profile of plasma non esterified fatty acid fraction

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Nov 2012 (estimated)
  2. Study startJun 2009
  3. Primary completionApr 2010
  4. Study completionApr 2010

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01735357
Sponsor's protocol ID
EDT
Status last verified
Sep 2019
First submitted
20 Nov 2012
Last updated
16 Sep 2019
Results posted
No
Data monitoring committee
No

Publications

  • Cottin SC, Alsaleh A, Sanders TA, Hall WL. Lack of effect of supplementation with EPA or DHA on platelet-monocyte aggregates and vascular function in healthy men. Nutr Metab Cardiovasc Dis. 2016 Aug;26(8):743-51. doi: 10.1016/j.numecd.2016.03.004. Epub 2016 Mar 15.

    PubMed 27105870

Questions about this trial

What is this clinical trial studying?

A study testing EPA-rich triacylglycerol oil and DHA-rich triacylglycerol oil in people with Healthy, run by King's College London 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 5 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 Sep 2019. 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?

Platelet Monocyte Aggregates (PMA) (time frame: 6 weeks). 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 NCT01735357, 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 Sep 2019.

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