CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 42 enrolled
Drug / intervention
Fish oil capsules +1 moredietary
Likely dose
Fish oil 1.8 g/day n-3 PUFA (360 mg EPA + 270 mg DHA) for 12 weeksAI-extracted
Key inclusion· 4
  • Age 40–70 years
  • Non-smoker
  • At moderate cardiovascular risk (QRISK2 10–20%)
  • Risk assessment via QRISK2 calculator scoring 10–20% for 10-year cardiovascular event risk
Key exclusion· 16
  • BMI <18.5 kg/m²
  • Anaemia: haemoglobin <12.5 g/L (men) or <11.5 g/L (women)
  • Hyperlipidaemia: total cholesterol >8 mmol/L
  • Diabetes or fasting glucose >7 mmol/L

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03203512
NCT03203512N/ACompleted

Effects of Fish Oil-derived N-3 Polyunsaturated Fatty Acids on the Generation and Functional Activities of Extracellular Vesicles

University of Reading·interventional·Posted Jun 29, 2017·Updated Nov 7, 2022

In Brief

A clinical study evaluating Fish oil capsules and High-oleic safflower oil capsules for Extracellular Vesicles; Generation and Function. Completed, enrolled 42 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJun 29, 2017
Enrollment StartFeb 16, 2018
Primary CompletionNov 30, 2019
Study CompletionMar 30, 2021
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 9.0 years ago

Interventions

Fish oil capsulesdietary

Each serving contains 360mg eicosapentaenoic acid (EPA), 270mg docosahexaenoic acid (DHA) and total supplement is 1.8 g per day n-3 PUFA for 12 weeks

High-oleic safflower oil capsulesdietary

High-oleic safflower oil capsules for 12 weeks