Condition category
Nutritional, Metabolic, Endocrine
Date applied
11/07/2019
Date assigned
12/07/2019
Last edited
12/07/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

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

https://www.basf.com/no/en/who-we-are/BASF-in-Norway.html

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

Publication citations

Additional files

Editorial Notes

12/07/2019: Trial’s existence confirmed by NHS HRA London – Brighton and Sussex Research Ethics Committee.