Condition category
Nutritional, Metabolic, Endocrine
Date applied
22/08/2012
Date assigned
05/09/2012
Last edited
17/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Philip Calder

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RHM NUT0062

Study information

Scientific title

Omega-3 fatty acids and inflammation in normal weight and obese subjects

Acronym

Study hypothesis

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

Berkshire Research Ethics Committee, 02/11/2011, ref: 11/SC/0384

Study design

Randomised placebo-controlled double-blind parallel study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/01/2012

Overall trial end date

30/06/2013

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50 normal weight and 50 moderately obese

Participant 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, Ą-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

Recruitment start date

01/02/2012

Recruitment end date

24/10/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Southampton
Southampton
SO16 6YD
United Kingdom

Sponsor information

Organisation

University Hospitals Southampton NHS Fiundation Trust (UK)

Sponsor details

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

Sponsor type

University/education

Website

http://www.uhs.nhs.uk/

Funders

Funder type

Government

Funder name

European Commission (EU)

Alternative name(s)

EC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Belgium

Results and Publications

Publication and dissemination plan

Results will be published across several papers in peer reviewed journals.

Intention to publish date

31/12/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27305954

Publication citations

Additional files

Editorial Notes

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.