Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2009-04-30
2009-12-31
Brief Summary
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Detailed Description
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The marine n-3 polyunsaturated fatty acids (PUFAs) have beneficial effects on cardiovascular disease. These effects are partly attributed to the anti-inflammatory effect of the n-3 PUFAs.
Previous studies have shown an anti-inflammatory effect of n-3 PUFAs in overweight subjects, but the studies have been conducted with a high daily dose of n-3 PUFA. We want to examine the effect of a lower dose of 1 g n-3 PUFA/day (the dose recommended by the Danish Heart Foundation).
The study is randomized, placebo-controlled and double blinded. Fifty subjects aged 30 - 75 years (postmenopausal women; waist circumference \> 80 cm and men; waist circumference \> 94 cm) will be included.
Blood samples and fatty tissue biopsies will be collected at baseline, after 1 day and after 6 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Fish oil
fish oil
Capsules. Approximately 1000 mg n-3 PUFA daily. One day + 6 weeks
Olive oil
olive oil
Capsules. Approximately 1 g olive oil daily. One day + 6 weeks
Interventions
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fish oil
Capsules. Approximately 1000 mg n-3 PUFA daily. One day + 6 weeks
olive oil
Capsules. Approximately 1 g olive oil daily. One day + 6 weeks
Eligibility Criteria
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Inclusion Criteria
* Postmenopausal (females)
Exclusion Criteria
* Daily intake of NSAIDs
* HbA1c ≥ 8%
* Serum creatinine ≤ 30 mL/min
* Chronic inflammatory disease
* Other serious illness
* Inability to informed consent
30 Years
75 Years
ALL
Yes
Sponsors
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Aalborg University Hospital
OTHER
Responsible Party
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Department of Cardiology, Aalborg Hospital, Aarhus University Hospital, Denmark
Locations
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Aalborg Hospital, Aarhus University Hospital
Aalborg, , Denmark
Countries
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References
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Hajer GR, van Haeften TW, Visseren FL. Adipose tissue dysfunction in obesity, diabetes, and vascular diseases. Eur Heart J. 2008 Dec;29(24):2959-71. doi: 10.1093/eurheartj/ehn387. Epub 2008 Sep 5.
Balkau B, Deanfield JE, Despres JP, Bassand JP, Fox KA, Smith SC Jr, Barter P, Tan CE, Van Gaal L, Wittchen HU, Massien C, Haffner SM. International Day for the Evaluation of Abdominal Obesity (IDEA): a study of waist circumference, cardiovascular disease, and diabetes mellitus in 168,000 primary care patients in 63 countries. Circulation. 2007 Oct 23;116(17):1942-51. doi: 10.1161/CIRCULATIONAHA.106.676379.
Libby P, Ridker PM, Maseri A. Inflammation and atherosclerosis. Circulation. 2002 Mar 5;105(9):1135-43. doi: 10.1161/hc0902.104353.
Calder PC. n-3 polyunsaturated fatty acids, inflammation, and inflammatory diseases. Am J Clin Nutr. 2006 Jun;83(6 Suppl):1505S-1519S. doi: 10.1093/ajcn/83.6.1505S.
Schmidt EB, Arnesen H, de Caterina R, Rasmussen LH, Kristensen SD. Marine n-3 polyunsaturated fatty acids and coronary heart disease. Part I. Background, epidemiology, animal data, effects on risk factors and safety. Thromb Res. 2005;115(3):163-70. doi: 10.1016/j.thromres.2004.09.006.
Schmidt EB, Arnesen H, Christensen JH, Rasmussen LH, Kristensen SD, De Caterina R. Marine n-3 polyunsaturated fatty acids and coronary heart disease: Part II. clinical trials and recommendations. Thromb Res. 2005;115(4):257-62. doi: 10.1016/j.thromres.2004.09.007. No abstract available.
Browning LM, Krebs JD, Moore CS, Mishra GD, O'Connell MA, Jebb SA. The impact of long chain n-3 polyunsaturated fatty acid supplementation on inflammation, insulin sensitivity and CVD risk in a group of overweight women with an inflammatory phenotype. Diabetes Obes Metab. 2007 Jan;9(1):70-80. doi: 10.1111/j.1463-1326.2006.00576.x.
Kris-Etherton PM, Harris WS, Appel LJ; AHA Nutrition Committee. American Heart Association. Omega-3 fatty acids and cardiovascular disease: new recommendations from the American Heart Association. Arterioscler Thromb Vasc Biol. 2003 Feb 1;23(2):151-2. doi: 10.1161/01.atv.0000057393.97337.ae. No abstract available.
Other Identifiers
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ADIPOMEGA
Identifier Type: -
Identifier Source: org_study_id
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