Plain English Summary
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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RHM NUT0061
Study information
Scientific title
Incorporation of omega-3 fatty acids from different chemical forms into blood lipid pools in healthy humans
Acronym
Study hypothesis
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
Southampton and South west Hampshire Research Ethics Committee, 02/06/2011, ref: 11/SC/0049
Study design
Randomised placebo-controlled double-blind parallel study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Drug names
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 trial start date
01/01/2012
Overall trial end date
31/12/2012
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
100
Participant 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
Recruitment start date
01/01/2012
Recruitment end date
31/12/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Southampton General Hospital
Southampton
SO16 6YD
United Kingdom
Sponsor information
Organisation
Southampton University Hospitals NHS Trust (UK)
Sponsor details
Research & Development Offices
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Vifor Pharma (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27424661