The effect of oily fish and fish oil supplementation on markers of cardiovascular health and exercise performance
| ISRCTN | ISRCTN13031606 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13031606 |
- Submission date
- 30/08/2024
- Registration date
- 10/09/2024
- Last edited
- 10/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Evidence from observational studies, prospective cohort studies and randomized clinical intervention studies indicate that moderate doses of long-chain n-3 polyunsaturated fatty acids (LC n-3 PUFA) significantly decrease the risk of fatal coronary heart disease (CHD). The exact mechanisms through which LC n-3 PUFA affects CHD are not well established but may include a decrease in fasting and postprandial triacylglycerol levels, a decrease in arrhythmias, modulation of platelet aggregation and decreased synthesis of pro-inflammatory agents and improved vascular function. In addition, there is a strong positive correlation between patients with cardiovascular disease and low mood/depression. Omega-3 highly unsaturated fatty acids (HUFAs) were recently reported in a meta-analytic review published by the British Journal of Psychiatry to have an effect size of .061 in reducing clinical symptoms of depression. The UK recommendation is that people eat at least two portions (with a portion being 140 g) of fish per week, one of which should be oily fish. Despite recommendations and sufficient availability, the majority of the UK population does not consume enough fish, particularly oily fish, and should be encouraged to increase consumption. However, it is unknown whether the benefits of eating fish come from the omega-3 fatty alone, or in combination with other macro and micronutrients within the fish. This research aims to investigate the health benefits of oily fish consumption, at a level achievable in the diet, compared to omega-3 supplementation on markers of cardiovascular health and exercise performance.
Who can participate?
Participants are required to be >40 years old, BMI >20 kg/m² and CVD scoring tool using the Framingham Risk Score
What does the study involve?
The study involves 2 testing sessions and 1 screening session where blood and urine samples are collected, and functional cognition measures and cardiovascular measures are carried out, as well as a submaximal exercise test.
Participants are assigned into one of three groups:
Group 1: placebo supplement + oily fish
Group 2: fish oil supplement + white fish
Group 3: placebo supplement + white fish
At the end of 12 weeks, participants returned to the University for a repeat session of testing.
Blood samples were used to assess:
Omega-3 index,– University of Southampton
Blood lipid profiles, number and procoagulant activity of extracellular vesicles – University of Reading
What are the possible benefits and risks of participating?
Participants will find out their blood lipid profile, and omega-3 index as well as their current fitness level.
Where is the study run from?
The School of Sport and Exercise Sciences, Liverpool John Moores University (UK)
When is the study starting and how long is it expected to run for?
July 2015 to March 2021
Who is funding the study?
British Broadcasting Corporation (UK)
Who is the main contact?
Prof Parveen Yaqoob, p.yaqoob@reading.ac.uk
Contact information
Public, Scientific, Principal Investigator
Liverpool John Moores University, School of Sport and Exercise Sciences, Tom Reilly Building, Byrom Street
Liverpool
L3 3AF
United Kingdom
 ORCID ID |
0000-0002-7210-9553 |
|---|---|
| Phone | +44 (0)151 904 6266 |
| G.L.Close@ljmu.ac.uk |
Scientific, Principal Investigator
Vice-Chancellor's Office, Whiteknights House, University of Reading
Reading
RG6 6UR
United Kingdom
| ORCID ID |
0000-0002-6716-7599 |
|---|---|
| Phone | +44 (0)118 378 8716 - 7113 |
| p.yaqoob@reading.ac.uk |
Study information
| Study design | Randomized double-blind placebo-controlled parallel trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Home, University/medical school/dental school |
| Study type | Prevention, Quality of life |
| Participant information sheet | Not available in web format. Please use contact details to request a participant information sheet |
| Scientific title | Effects of fish oil supplements vs oily fish on the number, phenotype and procoagulant activity of extracellular vesicles |
| Study objectives | Fish oil is more effective than oily fish in reducing the number and of thrombogenic activity of extracellular vesicles |
| Ethics approval(s) |
Approved 31/07/2015, LJMU’s Research Ethics Committee (Research and Innovation Services 1st Floor, Exchange Station, Tithebarn St, Liverpool, L2 2QP, United Kingdom; +44 (0)151 904 6467; researchethics@ljmu.ac.uk), ref: S16SPS041 |
| Health condition(s) or problem(s) studied | Prevention of cardiovascular disease in subjects who were at above average risk of developing CVD. |
| Intervention | 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 samples collected, and functional cognition measures and cardiovascular measures carried out, as well as a submaximal exercise test. Volunteers will then be asked to eat 2 portions of fish per week and take a supplement daily for 12 weeks. Participants will be randomized into one of three groups: Group 1: placebo supplement + oily fish Group 2: fish oil supplement + white fish Group 3: placebo supplement + white fish Fish oil capsules are provided as 2.2 g/d of n-3 PUFA ethyl esters. Two oily fish meals contain 1.44 g/d of n-3 PUFA (one meal containing salmon and the other mackerel). At the end of 12 weeks, participants will return to the University for a repeat session of testing (blood, urine and functional measures). |
| Intervention type | Behavioural |
| Primary outcome measure | Circulating extracellular vesicles (EVs) numbers are measured using Nanoparticles Tracking Analysis at baseline and after the intervention |
| Secondary outcome measures | 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 |
| Overall study start date | 31/07/2015 |
| Completion date | 09/03/2021 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 40 Years |
| Upper age limit | 73 Years |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 42 |
| Key inclusion criteria | 1. >40 years old 2. BMI >20 kg/m² 3. CVD scoring tool using the Framingham Risk Score |
| Key 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 |
| Date of first enrolment | 15/08/2016 |
| Date of final enrolment | 01/12/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Mount Pleasant
Liverpool
L3 5UX
United Kingdom
Sponsor information
Industry
Leila Finikarides, BBC Trust Me I'm A Doctor, London Broadcasting House, 5th Floor Zone E, Portland Place, now at the Winton Centre for Evidence and Risk Communication, Cambridge
London
W1A 1AA
United Kingdom
| Phone | 01223 337733 |
|---|---|
| lf426@cam.ac.uk | |
| Website | https://www.bbc.co.uk/programmes/b04j9gny and wintoncentre@maths.cam.ac.uk |
"ROR" |
https://ror.org/01qepzr42 |
Funders
Funder type
Other
Government organisation / For-profit companies (industry)
- Alternative name(s)
- BBC Worldwide, BBC Research and Development, BBC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/09/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publicly available repository in the University of Reading data repository https://doi.org/10.17864/1947.001350 |
Editorial Notes
10/09/2024: Trial's existence confirmed by LJMU’s Research Ethics Committee
