The effect of oily fish and fish oil supplementation on markers of cardiovascular health and exercise performance

Effects of fish oil supplements vs oily fish on the number, phenotype and procoagulant activity of extracellular vesicles

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13031606

Enrollment

Registered

2024-09-10

Start date

2016-08-15

Completion date

Unknown

Last updated

2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of cardiovascular disease in subjects who were at above average risk of developing CVD. Circulatory System

Interventions

This is a randomized, double-blind, placebo-controlled, parallel trial. Volunteers will be asked to attend 2 testing and 1 screening session at the University where blood will be taken, urine sample

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. >40 years old 2. BMI >20 kg/m² 3. CVD scoring tool using the Framingham Risk Score

Exclusion criteria

Exclusion criteria: 1. Infection 2. Immune disorder including HIV, autoimmune disease, or fever of unknown origin 3. Unstable medical conditions requiring immediate intervention 4. Unstable or rapidly progressive neurological diseases 5. A history of haemorrhagic or ischemic stroke within the last 3 months 6. Consuming oily fish more than once per week on average 7. Allergy, hypersensitivity, or intolerance to fish, fish oils or omega-3 fats 8. Any known food allergies 9. Pregnant or breastfeeding

Design outcomes

Primary

Measure	Time frame
Circulating extracellular vesicles (EVs) numbers are measured using Nanoparticles Tracking Analysis at baseline and after the intervention	—

Secondary

Measure	Time frame
The following secondary outcome measures are assessed at baseline and after the intervention: 1. Numbers of EV subpopulations including phosphatidylserine-positive EVs, platelet-derived EVs and endothelial-derived EVs are measured using a flow cytometer 2. Fatty acid compositions of circulating EVs and red blood cells (RBCs) are measured using gas chromatography 3. Thrombogenicity of circulating EVs is measured using a thrombin generation assay 4. Clot-forming and fibrinolytic capacity of circulating EVs are measured using clot formation assay and plasmin generation assay 5. Plasma lipid profile including triglycerides, total cholesterol, low-density lipoprotein and high-density lipoprotein, and plasma glucose levels are measured using Daytona Plus clinical chemistry analyzer	—

Measure

Time frame

The following secondary outcome measures are assessed at baseline and after the intervention: 1. Numbers of EV subpopulations including phosphatidylserine-positive EVs, platelet-derived EVs and endothelial-derived EVs are measured using a flow cytometer 2. Fatty acid compositions of circulating EVs and red blood cells (RBCs) are measured using gas chromatography 3. Thrombogenicity of circulating EVs is measured using a thrombin generation assay 4. Clot-forming and fibrinolytic capacity of circulating EVs are measured using clot formation assay and plasmin generation assay 5. Plasma lipid profile including triglycerides, total cholesterol, low-density lipoprotein and high-density lipoprotein, and plasma glucose levels are measured using Daytona Plus clinical chemistry analyzer

—

Countries

England, United Kingdom

Contacts

Public ContactGraeme Close

G.L.Close@ljmu.ac.uk+44 (0)151 904 6266

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026