Clinical trial NCT00885053: Fish Oil and Inflammation in Overweight Subjects
Official title: The Effect of Acute and Short-term Intervention With Fish Oil on Overweight Subjects - Focus on Inflammation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Keywords: Inflammation
Fatty acids, Omega 3
Leukotrienes
Adiponectin
Adipose tissue
RNA, Messenger
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2009-04-21
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to investigate the effects of acute and short-term intervention with fish oil on inflammatory markers in overweight subjects.

Detailed description: Being overweight is associated with metabolic syndrome, cardiovascular disease, and diabetes mellitus (type 2). Adipose tissue can be regarded as an active organ, which produces an array of inflammatory mediators. This creates a state of chronic low-grade inflammation. Inflammation has been proven to be a key element in the development of atherosclerotic plaques.

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.

Eligibility criteria: Inclusion Criteria:

* Waist circumference ≥ 80 cm (females) or ≥ 94 cm (males)
* Postmenopausal (females)

Exclusion Criteria:

* Daily intake of fish oil capsules
* Daily intake of NSAIDs
* HbA1c ≥ 8%
* Serum creatinine ≤ 30 mL/min
* Chronic inflammatory disease
* Other serious illness
* Inability to informed consent

Primary outcomes:
measure: To assess the effect of 1 g/day of n-3 polyunsaturated fatty acids on inflammatory markers
timeFrame: After 1 day and after 6 weeks intervention
Secondary outcomes:
measure: To assess effect of 1 g n-3 polyunsaturated fatty acids (daily dose) on the fatty acid profile of plasma, leucocytes and adipose tissue.
timeFrame: After 1 day and 6 after weeks of intervention
measure: To assess the effect of 1g n-3 polyunsaturated fatty acids (daily dose) on the gene expression profile (mRNA) - especially genes involved in encoding the inflammatory response.
timeFrame: After 1 day and 6 after weeks of intervention
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg Hospital, Aarhus University Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: Libby P, Ridker PM, Maseri A. Inflammation and atherosclerosis. Circulation. 2002 Mar 5;105(9):1135-43. doi: 10.1161/hc0902.104353.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.