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

NCT01735357 | Completed

• 1 other identifier: EDT
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Eicosapentaenoic acid; Docosahexaenoic acid; Cardiovascular risk; Platelet function; Endothelial function; Vascular function; young males

Outcome Measures

Primary Outcomes (2)

• 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.

  6 weeks

• 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+).

  6 weeks

Secondary Outcomes (17)

• Capillary density

  6 weeks

• Arterial stiffness

  6 weeks

• Blood Pressure (BP) and Heart Rate (HR)

  6 weeks

• Plasma isoprostane concentrations

  6 weeks

• Plasma Nitrate and Nitrites (NOx) concentrations

  6 weeks

Study Arms (3)

Olive oil (BP specification)

PLACEBO COMPARATOR

5g per day

Dietary Supplement: Placebo - olive oil (BP specification)

DHA-rich oil

EXPERIMENTAL

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

Dietary Supplement: DHA-rich triacylglycerol oil

EPA-rich oil

EXPERIMENTAL

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

Dietary Supplement: EPA-rich triacylglycerol oil

Interventions

EPA-rich triacylglycerol oil DIETARY_SUPPLEMENT

EPA-rich oil

Placebo - olive oil (BP specification) DIETARY_SUPPLEMENT

Olive oil (BP specification)

DHA-rich triacylglycerol oil DIETARY_SUPPLEMENT

DHA-rich oil

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College London: lead

Study Sites (1)

Diabetes & Nutritional Sciences Division, King's College London

London, SE1 9NH, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 27105870 DERIVED

Related Links

• Related Info

Study Officials

• Wendy L Hall, PhD

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in Nutritional Sciences

Study Record Dates

• First Submitted: November 20, 2012
• First Posted: November 28, 2012
• Study Start: June 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: September 16, 2019

Record last verified: 2019-09

Locations

GB (1)