ISRCTN ISRCTN46532656
DOI https://doi.org/10.1186/ISRCTN46532656
Secondary identifying numbers RHM NUT0061
Submission date
03/08/2012
Registration date
08/08/2012
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
We are carrying out a study to compare the appearance in the blood of two omega-3 fats, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), as a result of the taking supplements providing omega-3 fats in different chemical forms. Our goal is to find out whether the chemical form of the supplement affects the incorporation of the fatty acids into blood fats and blood cells. If the different chemical forms are incorporated to different extents or at different rates this may influence their ability to affect health. Thus this information will be important to consumers, to supplement manufacturers, and to government and other regulatory authorities.

Who can participate?
100 healthy men and women aged 18 to 45 years.

What does the study involve?
Participants will be randomly allocated to take one of five supplements daily for 12 weeks (either omega-3 fats in one of four chemical forms or a placebo [dummy] supplement). Participants will make clinic visits at the start of the study and at weeks 1, 2, 4, 8 and 12. Blood will be collected at each clinic visit. At the end of the study, we will compare the amount of EPA and DHA in the blood and in blood cells in order to see if there is a difference between the supplements.

What are the possible benefits and risks of participating?
There will be 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?
Study recruitment started in January 2012 and participants were enrolled for 12 weeks.

Who is funding the study?
Vifor Pharma (Switzerland).

Who is the main contact?
Professor Philip Calder
pcc@soton.ac.uk

Contact information

Prof Philip Calder
Scientific

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

Study information

Study designRandomised placebo-controlled double-blind parallel study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeOther
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleIncorporation of omega-3 fatty acids from different chemical forms into blood lipid pools in healthy humans
Study objectivesThe appearance of Eicosapentaenoic acid (EPA) and Docosahexaenoic acid (DHA) in plasma lipids and blood cells will differ according to chemical formulation of the parent oil.
Ethics approval(s)Southampton and South west Hampshire Research Ethics Committee, 02/06/2011, ref: 11/SC/0049
Health condition(s) or problem(s) studiedHealthy subjects
InterventionParticipants were allocated to one of the following groups:
1. Placebo
2. Omega-3 ethyl esters
3. Omega-3 free fatty acids
4. Omega-3 triglycerides (standard formulation)
5. Omega-3 triglycerides (interesterified formulation)

All forms of supplement provide 1.1 g EPA plus 0.4 g DHA daily. Supplements will be taken orally. The duration of treatment will be 3 months. Blood samples will be taken during supplementation at 0, 1, 2, 4, 8 and 12 weeks.
Intervention typeSupplement
Primary outcome measureChange in EPA content of plasma phospholipids from study entry to week 12
Secondary outcome measures1. Change in EPA content of each of the other plasma lipid pools and of mononuclear cells and red blood cells from study entry to week 12
2. Change in DHA content of each of the plasma lipid pools and of mononuclear cells and red blood cells from study entry to week 12
3. Change over time in blood concentrations of inflammatory markers
Overall study start date01/01/2012
Completion date31/12/2012

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants100
Total final enrolment100
Key inclusion criteria1. Healthy
2. Aged 18 to 45 years
3. Body mass index 20 to 32 kg/m2
4. Not consuming fish oil or other oil 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
Key exclusion criteria1. Aged < 18 or > 45 years
2. Body mass index < 20 or > 32 kg/m2
3. Being diabetic (type 1 or type 2)
4. Use of prescribed medicine to control inflammation
5. Chronic gastrointestinal problems (e.g. IBD, IBS, celiac disease, cancer)
6. Allergic to fish
7. Participation in another clinical trial
8. Use of fish oil or other oil supplements
Date of first enrolment01/01/2012
Date of final enrolment31/12/2012

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Southampton General Hospital
Southampton
SO16 6YD
United Kingdom

Sponsor information

Southampton University Hospitals NHS Trust (UK)
Hospital/treatment centre

Research & Development Offices
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
England
United Kingdom

Website http://www.uhs.nhs.uk/
ROR logo "ROR" https://ror.org/0485axj58

Funders

Funder type

Industry

Vifor Pharma (Switzerland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planNot provided at time of registration
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 01/09/2016 Yes No
Protocol file version 2 14/04/2011 16/02/2023 No No

Additional files

ISRCTN46532656_PROTOCOL_V2_14Apr11.pdf

Editorial Notes

17/02/2023: Total final enrolment and IPD sharing statement added.
16/02/2023: Protocol file uploaded (not peer reviewed).
27/04/2018: Publication reference corrected.
14/06/2017: Publication reference added.