Omega-3 fatty acids and inflammatio

Not Applicable

Completed

• Conditions: Healthy and moderately obese subjects; Obesity; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN96712688
• Lead Sponsor: niversity Hospitals Southampton NHS Fiundation Trust (UK)

Brief Summary

2016 Results article in http://www.ncbi.nlm.nih.gov/pubmed/27305954 Effects on lysophospholipid metabolism 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35958557/ Obesity-associated tissue remodelling (added 15/08/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35247847/ (added 16/02/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-09-05
• Study Completion: 2013-06-30
• Last Update Posted: 27 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 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<br> 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<br> 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<br>

Secondary Outcome Measures

Name	Time	Method
<br> 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<br> 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<br> 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<br>