Plain English Summary
Background and study aims
Omega-3 fatty acids are essential in the diet, as the body is unable to make them itself (essential fatty acids). Although they can be found in plant sources, the most important omega-3 fatty acids are eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), which are only found in certain types of fish. There is a wide variety of different omega-3 supplements of the market, which provide EPA and DHA in different forms. Omega-3 fatty acids from foods and from supplements need to be digested in the small intestine. Emulsification is an early part of the digestive process and makes the omega-3 fatty acids more soluble. Limited emulsification may limit omega-3 fatty acid uptake into the body (bioavailability). The components within some omega-3 supplements may help with the emulsification process. We think that having a mix of glycerides might help in this way. This is what we will test in this study. The appearance in the blood of EPA and DHA will be compared after taking omega-3 fats in two different forms, with one of these being the special mix of glycerides, and the other one being in ethyl ester form which is the common form of many omega-3 supplements today. The aim of the study is to find out whether having the mix of glycerides within an omega-3 supplement affects the way the fatty acids incorporate into blood fats.
Who can participate?
Healthy men and women aged 50 to 70 years
What does the study involve?
Participants will receive two different omega-3 supplements in random order. They will take each supplement on a single occasion separated by about two weeks. They will be fasted when they take each supplement. Blood samples will be collected several times up to 12 hours after taking each supplement. The amount of EPA and DHA in the blood will be compared in order to see if there is a difference between the two supplements.
What are the possible benefits and risks of participating?
There is no immediate direct benefit to those taking part. There is a very small chance of infection and a chance of bleeding and bruising at the site of insertion of the needle for collecting the blood sample.
Where is the study run from?
University of Southampton (UK)
When is the study starting and how long is it expected to run for?
August 2019 to October 2019
Who is funding the study?
BASF AS (Norway)
Who is the main contact?
Prof. Philip Calder
pcc@soton.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Prof Philip Calder
ORCID ID
http://orcid.org/0000-0002-6038-710X
Contact details
Faculty of Medicine
University of Southampton
MP887 Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
02381205250
pcc@soton.ac.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
CTN800218102
Study information
Scientific title
Influence of an omega-3 fatty acid triglyceride formulation on EPA and DHA appearance in human plasma after single dosing
Acronym
Study hypothesis
An omega-3 supplement containing a mix of glycerides will enhance bioavailability of the omega-3 fatty acids EPA and DHA
Ethics approval
Approved 01/07/2019, NHS HRA London – Brighton and Sussex Research Ethics Committee (Boardroom, Sussex House, Royal Sussex County Hospital, 1 Abbey Road, Brighton, BN2 1ES; 020 797 22567; NRESCommittee.SECoast-BrightonandSussex@nhs.net), ref: 19/LO/0939
Study design
Double-blind random order cross-over trial
Primary study design
Interventional
Secondary study design
Randomised cross over trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Omega-3 fatty acid supplementation
Intervention
Patients are manually randomised to the order in which they will take the two supplements by the hospital research pharmacist. The two supplements are:
1. Omega-3 ethyl esters providing 500 mg EPA + 200 mg DHA
2. Omega-3 glyceride formulation providing 500 mg EPA + 200 mg DHA
The first supplement (4 capsules) will be taken in the fasting state. Blood samples will be collected at 0, 1, 2, 3, 4, 5, 6, 8 and 12 hours. This will be repeated about two weeks later with the second supplement.
Randomisation will be performed by a University Hospital Southampton research pharmacist using the alea system.
Intervention type
Supplement
Phase
Drug names
Primary outcome measure
Concentration of EPA and DHA in plasma measured by gas chromatography at different time points up to 12 hours
Secondary outcome measures
Tolerability will be assessed simply by monitoring adverse events. Subjects will spend 2 x 12 hour days for clinic visits and adverse events will be monitored across each of these visits.
Overall trial start date
01/07/2018
Overall trial end date
31/10/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Healthy males and females
2. Age 50 to 70 years
3. Body mass index 20 to 35 kg/m2
5. Not eating more than one oily fish meal per week
6. Willing to adhere to the study protocol
7. Able to provide written informed consent
8. Omega-3 index (EPA+DHA in red blood cells) ≤ 6.5 at screening visit
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
20
Participant exclusion criteria
1. Diabetic (type 1 or type 2)
2. Vegetarian or vegan and unwilling to consume capsules with a beef gelatine coating
3. Use of prescribed medicine to control inflammation
4. Smokers
5. Alcohol consumption > 14 units per week
5. Chronic gastrointestinal problems (e.g. IBD, IBS, celiac disease, cancer)
6. Allergic to fish
7. Use of fish oil or other oil supplement
8. Participation in another clinical trial (currently or in the 12 weeks prior to study entry)
9. Pregnancy or lactation
10. Blood donations during 3 months prior to or during the study period
Recruitment start date
01/08/2019
Recruitment end date
30/09/2019
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University Hospital Southam,pton NHS Foundation Trust
Tremona Road
Southampton
SO16 6YD
United Kingdom
Sponsor information
Organisation
BASF AS
Sponsor details
Lilleakerveien 2c
Oslo
0283
Norway
+47 9927-2623
Svein.Olaf.Hustvedt@basf.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
BASF AS (Norway)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in peer reviewed journal
IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date
Intention to publish date
01/04/2020
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list