Incorporation of omega-3 fatty acids in healthy humans
| ISRCTN | ISRCTN96459690 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96459690 |
| Secondary identifying numbers | CTN00715201 |
- Submission date
- 13/02/2017
- Registration date
- 14/02/2017
- Last edited
- 17/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
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 are 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). Conversely pre-emulsification may promote omega-3 fatty acid uptake into the body. A self-microemulsifying drug delivery system (SMEDDS) promotes emulsification after oral consumption. In this study, the appearance in the blood of EPA and DHA will be compared after taking omega-3 fats in emulsified or SMEDDS forms. The aim of this study is to find out whether the self-emulsification of the supplement affects the way the fatty acids incorporate into blood fats and blood cells.
Who can participate?
Healthy men and women aged 18 to 65
What does the study involve?
Participants are randomly allocated to take one of four omega-3 supplements daily for 12 weeks (either emulsified or SMEDDS forms and at different doses). Participants make clinic visits at the start of the study and at weeks 1, 4 and 12. Blood samples are collected at each clinic visit. The amount of EPA and DHA in the blood and in blood cells are compared in order to see if there is a difference between the 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?
July 2015 to August 2017
Who is funding the study?
Pronova BioPharma
Who is the main contact?
Prof. Philip Calder
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 |
|---|
Study information
| Study design | Double-blind randomised parallel trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not availble in web format, please use contact details to request a participant information sheet |
| Scientific title | Incorporation of omega-3 fatty acids in healthy humans following oral dosing of dietary supplements |
| Study objectives | A self-microemulsifying drug delivery system (SMEDDS) will enhance bioavailability of the omega-3 fatty acids EPA and DHA. |
| Ethics approval(s) | South Central - Hampshire A Research Ethics Committee, 11/01/2016, ref: 15/SC/0775 |
| Health condition(s) or problem(s) studied | Omega-3 fatty acid supplementation |
| Intervention | Patients are manually randomised by the hospital research pharmacist to one of four groups: 1. Omega-3 ethyl esters providing 230 mg EPA + 190 mg DHA 2. SMEDDS Omega-3 ethyl esters providing 230 mg EPA + 190 mg DHA 3. Omega-3 ethyl esters providing 90 mg EPA + 300 mg DHA 4. SMEDDS Omega-3 ethyl esters providing 90 mg EPA + 300 mg DHA Supplements (3/day) will be taken orally before breakfast. Duration of treatment will be three months. Blood samples will be collected at 0 (samples at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours), 1, 4 and 12 weeks. |
| Intervention type | Supplement |
| Primary outcome measure | Concentration of EPA and DHA in red blood cells, measured by gas chromatography at baseline, 1, 4 and 12 weeks |
| Secondary outcome measures | Concentration of EPA and DHA in plasma and white blood cells, measured by gas chromatography at baseline, 1, 4 and 12 weeks |
| Overall study start date | 01/07/2015 |
| Completion date | 01/08/2017 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 80 |
| Total final enrolment | 80 |
| Key inclusion criteria | 1. Healthy males and females 2. Age 18 to 65 years 3. Body mass index 20 to 35 kg/m2 4. Not consuming fish oil or similar supplements 5. Not eating more than one oily fish meal per week 6. Willing to adhere to the study protocol 7. Being able to provide written informed consent 8. Omega-3 index (EPA+DHA in red blood cells_ < 6.5 at screening |
| Key exclusion criteria | 1. Being diabetic (type 1 or type 2) 2. Being vegetarian or vegan and unwilling to consume capsules with a beef gelatine coating 3. Use of prescribed medicine to control inflammation 4. Smokers 5. Chronic gastrointestinal problems (e.g. IBD, IBS, celiac disease, cancer) 6. Allergic to fish 7. Allergic to soybean 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 11. Omega-3 index (EPA+DHA in red blood cells > 6.5 at screening |
| Date of first enrolment | 18/04/2016 |
| Date of final enrolment | 01/03/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
SO16 6YD
United Kingdom
Sponsor information
Industry
Lilleakerveien 2c
Oslo
0283
Norway
"ROR" |
https://ror.org/03ccpe393 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/08/2018 |
|---|---|
| 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 (likely 2018) |
| 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 | 01/11/2018 | Yes | No | |
| Protocol file | version 4 | 27/05/2016 | 16/02/2023 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
17/02/2023: Total final enrolment and IPD sharing statement added.
16/02/2023: Protocol uploaded (not peer reviewed).
12/09/2018: Publication reference added.
