Omega-3 fatty acids and inflammation
| ISRCTN | ISRCTN96712688 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96712688 |
| Secondary identifying numbers | RHM NUT0062 |
- Submission date
- 22/08/2012
- Registration date
- 05/09/2012
- Last edited
- 16/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims:
We are carrying out a study of 50 healthy normal weight subjects and 50 moderately obese subjects to compare the anti-inflammatory effects of omega-3 fats, to see if they work differently in normal weight and obese people. We will measure inflammatory chemicals in the bloodstream and in fat tissue of the study participants in two different settings.
Who can participate?
The study will recruit 50 normal weight healthy men and women aged 18 to 65 years and 50 moderately obese men and women aged 18 to 65 years.
What does the study involve?
Participants will firstly take part in three clinic visits where they will consume a standard high fat meal or the high fat meal and an omega-3 supplement. The first will be in the first six hours after eating a standard high fat meal or the high fat meal along with an omega-3 supplement. Only blood samples will be collected in this part of the study. The second will be after taking a daily omega-3 supplement of a control supplement for a period is 12 weeks. In this part of the study both blood samples and a small piece of fat tissue from the lower abdomen will be collected. Our goal is to find out whether omega-3 fats have the same anti-inflammatory effects in normal weight and moderately obese people. Finally participants will have another clinic visit to consume the same standard high fat meal as before with collection of blood samples over six hours. The purpose of this is to see if the period of 12 weeks of taking the omega-3 supplement has altered the way the participants respond to the meal. This information will be important to consumers, to supplement manufacturers, and to government and other regulatory authorities.
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 blood samples and the fat tissue.
Where is the study run from?
University of Southampton (UK)
When is study starting and how long is it expected to run for?
January 2012 to June 2016
Who is funding the study?
European Commission (Belgium)
Who is the main contact?
Prof. Philip Calder
pcc@soton.ac.uk
Contact information
Scientific
University of Southampton
Faculty of Medicine
Southampton General Hospital
IDS Building
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) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Omega-3 fatty acids and inflammation in normal weight and obese subjects |
| Study objectives | 1. The post-prandial inflammatory response will be exaggerated in obese compared with normal weight subjects 2. Marine omega-3 fatty acids with a meal will reduce the post-prandial inflammatory response to a high fat meal in both normal weight and obese subjects 3. Chronic intake of marine omega-3 fatty acids will reduce inflammation in both normal weight and obese subjects 4. Chronic intake of marine omega-3 fatty acids will reduce the post-prandial inflammatory response to a high fat meal in both normal weight and obese subjects |
| Ethics approval(s) | Berkshire Research Ethics Committee, 02/11/2011, ref: 11/SC/0384 |
| Health condition(s) or problem(s) studied | Healthy and moderately obese subjects |
| Intervention | Placebo or marine omega-3 fats (1.8 g/day) to be taken as oral supplements. In phase 1 the supplements will be taken once with a standard high fat meal and blood samples wil be taken after 0, 1,2, 3, 4 and 6 hours. In phase 2 the supplements will be taken daily during supplementation for 12 weeks. Blood and fat tissue samples will be taken after 0 and 12 weeks. |
| Intervention type | Supplement |
| Primary outcome measure | 1. Blood inflammatory markers (a range of cytokines and chemokines) in response to a standard high fat meal measured by immunoassay at several time points up to 6 hours after the meal 2. Change from week 0 (study entry) in blood inflammatory markers (a range of cytokines and chemokines) measured by immunoassay after 12 weeks of consumption of omega-3 fatty acids or placebo 3. Change from week 0 (study entry) in fat tissue inflammation (infiltrating macrophages measured by immunohistochemistry and inflammatory markers measured as messenger RNA levels by RT-PCR) after 12 weeks of consumption of omega-3 fatty acids or placebo |
| Secondary outcome measures | 1. Blood lipids (triglycerides, fatty acids), glucose and various hormones (insulin, incretins) in response to a standard high fat meal measured at several time points up to 6 hours after the meal 2. Blood omega-3 fatty acids in response to a standard high fat meal measured by gas chromatography at several time points up to 6 hours after the meal 3. Change from week 0 (study entry) in blood omega-3 fatty acids measured by gas chromatography after 12 weeks of consumption of omega-3 fatty acids or placebo |
| Overall study start date | 01/01/2012 |
| Completion date | 30/06/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 50 normal weight and 50 moderately obese |
| Total final enrolment | 100 |
| Key inclusion criteria | 1. Male or female 2. Aged 18 to 65 years 3. Body mass index 18.5 to 25 or 30 to 40 kg/m2 4. If body mass index is 30 to 40 kg/m2 waist circumference is > 94 cm for men or > 80 cm for women 5. Not consuming fish oil or other oil supplements 6. Not eating more than one oily fish meal per week 7. Willing to adhere to the study protocol 8. Being able to provide written informed consent |
| Key exclusion criteria | 1. Aged < 18 or > 65 years 2. Body mass index < 18.5, 25-29.9 or > 40 kg/m2 3. If body mass index is 30 to 40 kg/m2 waist circumference is < 94 cm for men or < 80 cm for women 4. Diagnosed diabetes 5. Use of prescribed medicine to control inflammation 6. Use of prescribed medication to control blood lipids (e.g. statins, fibrates (fenofibrate), Omacor) 7. Use of prescribed medication to control blood pressure (ACE inhibitors, angiotensin 2 receptor blockers, calcium channel blockers, Ñ-inhibitors, thiozide diuretics) 8. Use of fish oil or other oil supplements 9. Chronic gastrointestinal problems (e.g. IBD, celiac disease, cancer) 10. Pregnant or planning to become pregnant within the study period 11. Participation in another clinical trial |
| Date of first enrolment | 01/02/2012 |
| Date of final enrolment | 24/10/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
SO16 6YD
United Kingdom
Sponsor information
University/education
Research & Development Office
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
Government
Government organisation / National government
- Alternative name(s)
- European Union, Comisión Europea, Europäische Kommission, EU-Kommissionen, Euroopa Komisjoni, Ευρωπαϊκής Επιτροπής, Европейската комисия, Evropské komise, Commission européenne, Choimisiúin Eorpaigh, Europskoj komisiji, Commissione europea, La Commissione europea, Eiropas Komisiju, Europos Komisijos, Európai Bizottságról, Europese Commissie, Komisja Europejska, Comissão Europeia, Comisia Europeană, Európskej komisii, Evropski komisiji, Euroopan komission, Europeiska kommissionen, EC, EU
Results and Publications
| Intention to publish date | 31/12/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository, Available on request |
| Publication and dissemination plan | Results will be published across several papers in peer reviewed journals. |
| IPD sharing plan | Some of the datasets generated during and/or analysed during the current study are stored in a publicly available repository (GEO; https://www.ncbi.nlm.nih.gov/geo/) under accession code GSE162653 (https://www.ncbi.nlm.nih.gov/geo/query/acc.cgi?acc=GSE162653). Other 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 | Effects on lysophospholipid metabolism | 01/08/2016 | Yes | No | |
| Results article | Obesity-associated tissue remodelling | 25/07/2022 | 15/08/2022 | Yes | No |
| Protocol file | version 3 | 07/12/2012 | 16/02/2023 | No | No |
| Results article | 02/03/2022 | 16/02/2023 | Yes | No |
Additional files
Editorial Notes
16/02/2023: Publication reference and IPD sharing statement added. Protocol file uploaded (not peer reviewed).
15/08/2022: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
17/06/2016: Publication reference added.
21/03/2016: The recruitment dates have been updated from 01/01/2012-30/06/2013 to 01/02/2012-20/10/2013. The publication and dissemination plan and availability of participant level data have also been updated and the methods of measurement have been added to the outcome measures.
