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

NCT ID: NCT01735357

Last Updated: 2019-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Olive oil (BP specification)

5g per day

Group Type PLACEBO_COMPARATOR

Placebo - olive oil (BP specification)

Intervention Type DIETARY_SUPPLEMENT

DHA-rich oil

Fish oil supplement (total = 5g/day) providing 3.1g/day of DHA triacylglycerol, blended with olive oil

Group Type EXPERIMENTAL

DHA-rich triacylglycerol oil

Intervention Type DIETARY_SUPPLEMENT

EPA-rich oil

Fish oil supplement (total = 5g/day) providing 2.9g/day of EPA triacylglycerol, blended with olive oil

Group Type EXPERIMENTAL

EPA-rich triacylglycerol oil

Intervention Type DIETARY_SUPPLEMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

EPA-rich triacylglycerol oil

Intervention Type DIETARY_SUPPLEMENT

Placebo - olive oil (BP specification)

Intervention Type DIETARY_SUPPLEMENT

DHA-rich triacylglycerol oil

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

King's College London

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr Wendy Hall

Lecturer in Nutritional Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Wendy L Hall, PhD

Role: PRINCIPAL_INVESTIGATOR

King's College London

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Diabetes & Nutritional Sciences Division, King's College London

London, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 27105870 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EDT

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.