N/A N=40 Randomized Triple-blind Prevention

Fish Oil-derived N-3 Polyunsaturated Fatty Acids and Extracellular Vesicles

Extracellular Vesicles; Generation and Function

Bottom Line

View on ClinicalTrials.gov: NCT03203512 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2022

Primary outcome: Primary: Numbers of Circulating Total EVs in Platelet-free Plasma (PFP) Detected by Nanoparticle Tracking Analysis (NTA) — -2.9*10^10; 7.5*10^9 vesicles per ml blood — p=<0.001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Fish oil capsules (Dietary_supplement); High-oleic safflower oil capsules (Dietary_supplement)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: University of Reading
Primary completion: Nov 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Numbers of Circulating Total EVs in Platelet-free Plasma (PFP) Detected by Nanoparticle Tracking Analysis (NTA)	-2.910^10; 7.510^9	<0.001 sig
PRIMARY Numbers of Total Phosphatidylserine Positive EVs (PS+EVs) in Platelet-free Plasma (PFP) Detected by Flow Cytometry (FCM)	-1.210^7; -3.010^5	=0.001 sig
PRIMARY Characterisation of Circulating EVs Subpopulation in PFP Detected by Fluorescence FCM	-6.010^6; -3.010^5; -5.510^5; 2.910^5	=0.002 sig
SECONDARY Pro-thrombotic Activities of Circulating EVs in PFP (Lag Time for Thrombin Generation)	2.5; 1.2	<0.001 sig
SECONDARY Pro-thrombotic Activities of Circulating EVs in PFP (Peak Thrombin Concentration)	-16.2; -1.6	<0.001 sig
SECONDARY Pro-thrombotic Activities of Circulating EVs in PFP (Time to Peak Thrombin Concentration)	4.6; 0.3	<0.001 sig
SECONDARY Pro-thrombotic Activities of Circulating EVs in PFP (Velocity Index)	-1.1; -0.2	=0.015 sig
SECONDARY Pro-thrombotic Activities of Circulating EVs in PFP (Endogenous Thrombin Potential)	-437.2; -60.8	<0.001 sig
SECONDARY Ex Vivo Agonist-stimulated Platelet Activation Detected by Plate-based Platelet Aggregation Assay	-0.17; -0.078; -0.36; 0.16; 0.20; 0.058	>0.05
SECONDARY Ex Vivo Agonist-stimulated Platelet Activation Detected by Plate-based Platelet Aggregation Assay (CRP-XL Log EC50)	-0.39; 0.032	>0.05
SECONDARY Pro-thrombotic Activities of Platelet-derived Extracellular Vesicles (PDEVs) Prepared From the Supernatants of Stimulated Platelets (Endpoint and Maximum of Thrombus Formation)	-14.3; 9.9; -1.3; 20.6	>0.05
SECONDARY Pro-thrombotic Activities of Platelet-derived Extracellular Vesicles (PDEVs) Prepared From the Supernatants of Stimulated Platelets (Area Under Curve)	-945; 2502	>0.05
SECONDARY Circulating EV Total Lipids Analysis	0.9; -0.1; 1.0; -0.02; 0.2; 0.04	<0.001 sig
SECONDARY Plasma Total Phospholipids Analysis	2.9; -0.1; 2.4; -0.1; 0.2; -0.1	<0.001 sig
SECONDARY Concentrations of Lipid Profile in Plasma	-0.1; 0.03; 0.1; -0.1; 0.1; -0.02	=0.016 sig
SECONDARY Concentrations of TC/HDL-C Ratio in Plasma	-0.04; -0.1	=0.285
SECONDARY Blood Pressure	-6.7; 3.4; -2.9; 0.9	<0.001 sig

Summary

N-3 polyunsaturated fatty acids (n-3 PUFA), which are abundant in oily fish and fish oils, have been suggested to play a role in reducing the risk of cardiovascular diseases (CVDs) by modifying a wide range of risk factors, such as blood fats, blood clotting, blood vessel function and inflammation. Extracellular vesicles (EVs) are small particles released from various cells when they are activated or damaged. High numbers of EVs in the blood have been associated with a higher risk of CVDs, and it is thought that this is because they carry 'bioactive' components which can affect many processes involved in CVDs. However, very few clinical trials have investigated the relationships between the consumption of n-3 PUFA and circulating EVs. This study aims to investigate the effects of dietary n-3 PUFA on the generation and functional activities of EVs, which would provide new insight into the benefits of n-3 PUFA on cardiovascular health.

Eligibility Criteria

Inclusion Criteria

Aged 40-70 years
Non-smoker
At moderate risk of cardiovascular diseases
The risk will be evaluated by an online calculator called "QRISK2". This online calculator (https://qrisk.org/2016/), which use traditional risk factors (age, systolic blood pressure, smoking status and ratio of total serum cholesterol to high-density lipoprotein cholesterol) together with body mass index, ethnicity, measures of deprivation, family history, will provide a percentage of risk of having a heart attack or stroke within the next 10 years.
Subjects with 10%-20% will be regarded as being at moderate risk

Exclusion Criteria

BMI: 8 mmol/L)
Diabetes (diagnosed or fasting glucose concentration >7 mmol/L) or other endocrine disorders
Angina, stroke, or any vascular disease in the past 12 months
Renal, gastrointestinal, respiratory, liver or bowel disease
Inflammatory disease
Take drug treatment for hypertension, hyperlipidaemia, inflammation, depression or thyropathy.
Take aspirin, ibuprofen or other nonsteroidal anti-inflammatory drugs (NSAIDs) > 4 times per month, or once in the week preceding the study
Take any other anti-platelet or anti-coagulant drugs, like triflusal, clopidogrel and warfarin.
Have allergies
Smoking (including e-cigarettes and nicotine products)
Alcohol misuse or intakes >21 units/wk for men and >15 units/wk for women or have a history of alcohol misuse
Regularly consume oily fish and/or dietary supplements
Planning to start or on a weight reducing regimen
Intense aerobic exercise (>20 min, three times a week)
Females who are pregnant, lactating, or if of reproductive age and not using a reliable form of contraception (including abstinence)
Have participated in another clinical trial within the last three months

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03203512). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.