Incorporation of omega-3 fatty acids
| 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
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
Scientific
Southampton General Hospital
Faculty of Medicine
Tremona Road
Southampton
SO16 6YD
United Kingdom
Study information
| Study design | Randomised placebo-controlled double-blind parallel study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Incorporation of omega-3 fatty acids from different chemical forms into blood lipid pools in healthy humans |
| Study objectives | The 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) studied | Healthy subjects |
| Intervention | Participants 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 type | Supplement |
| Primary outcome measure | Change in EPA content of plasma phospholipids from study entry to week 12 |
| Secondary outcome measures | 1. 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 date | 01/01/2012 |
| Completion date | 31/12/2012 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 100 |
| Key inclusion criteria | 1. 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 criteria | 1. 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 enrolment | 01/01/2012 |
| Date of final enrolment | 31/12/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
SO16 6YD
United Kingdom
Sponsor information
Hospital/treatment centre
Research & Development Offices
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
England
United Kingdom
| Website | http://www.uhs.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/0485axj58 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Not provided at time of registration |
| 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 | 01/09/2016 | Yes | No | |
| Protocol file | version 2 | 14/04/2011 | 16/02/2023 | No | No |
Additional files
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.
