Incorporation of omega-3 fatty acids
| ISRCTN | ISRCTN18364209 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18364209 |
| Secondary identifying numbers | CTN800218102 |
- Submission date
- 11/07/2019
- Registration date
- 12/07/2019
- Last edited
- 16/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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
Contact information
Scientific
Faculty of Medicine
University of Southampton
MP887 Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
 ORCID ID |
0000-0002-6038-710X |
|---|---|
| Phone | 02381205250 |
| pcc@soton.ac.uk |
Study information
| Study design | Double-blind random order cross-over trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Influence of an omega-3 fatty acid triglyceride formulation on EPA and DHA appearance in human plasma after single dosing |
| Study objectives | An omega-3 supplement containing a mix of glycerides will enhance bioavailability of the omega-3 fatty acids EPA and DHA |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/07/2018 |
| Completion date | 31/10/2019 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 20 |
| Total final enrolment | 20 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/08/2019 |
| Date of final enrolment | 30/09/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Southampton
SO16 6YD
United Kingdom
Sponsor information
Industry
Lilleakerveien 2c
Oslo
0283
Norway
| Phone | +47 9927-2623 |
|---|---|
| Svein.Olaf.Hustvedt@basf.com | |
| Website | https://www.basf.com/no/en/who-we-are/BASF-in-Norway.html |
"ROR" |
https://ror.org/03ccpe393 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/04/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in peer reviewed journal |
| IPD sharing plan | The anonymised datasets generated during and/or analysed during the current study are available upon request from Philip Calder (pcc@soton.ac.uk). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 13/10/2020 | 14/10/2020 | Yes | No |
| Protocol file | version 3 | 05/03/2019 | 16/02/2023 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
16/02/2023: Protocol file uploaded (not peer reviewed) and IPD sharing statement added.
14/10/2020: Publication reference and total final enrolment number added.
12/07/2019: Trial’s existence confirmed by NHS HRA London – Brighton and Sussex Research Ethics Committee.
