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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Prof Philip Calder
Scientific

Faculty of Medicine
University of Southampton
MP887 Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom

ORCiD logoORCID ID 0000-0002-6038-710X

Study information

Study designDouble-blind randomised parallel trial
Primary study designInterventional
Secondary study designRandomised parallel trial
Study setting(s)Hospital
Study typeOther
Participant information sheet Not availble in web format, please use contact details to request a participant information sheet
Scientific titleIncorporation of omega-3 fatty acids in healthy humans following oral dosing of dietary supplements
Study objectivesA 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) studiedOmega-3 fatty acid supplementation
InterventionPatients 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 typeSupplement
Primary outcome measureConcentration of EPA and DHA in red blood cells, measured by gas chromatography at baseline, 1, 4 and 12 weeks
Secondary outcome measuresConcentration of EPA and DHA in plasma and white blood cells, measured by gas chromatography at baseline, 1, 4 and 12 weeks
Overall study start date01/07/2015
Completion date01/08/2017

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants80
Total final enrolment80
Key inclusion criteria1. 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 criteria1. 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 enrolment18/04/2016
Date of final enrolment01/03/2017

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University Hospital Southampton NHS Foundation Trust
Southampton
SO16 6YD
United Kingdom

Sponsor information

Pronova BioPharma
Industry

Lilleakerveien 2c
Oslo
0283
Norway

ROR logo "ROR" https://ror.org/03ccpe393

Funders

Funder type

Industry

Pronova BioPharma

No information available

Results and Publications

Intention to publish date01/08/2018
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in peer reviewed journal (likely 2018)
IPD sharing planThe 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

ISRCTN96459690_PROTOCOL_V4_27May16.pdf

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.