Healthy and moderately obese subjects Nutritional, Metabolic, Endocrine Obesity
Conditions
Interventions
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 a
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,
Sponsors
University Hospitals Southampton NHS Fiundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: 1. Aged 65 years 2. Body mass index 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
| 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 | — |
Countries
England, United Kingdom
Outcome results
None listed