Fish Oil and Inflammation in Overweight Subjects (ADIPOMEGA)
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|ClinicalTrials.gov Identifier: NCT00885053|
Recruitment Status : Completed
First Posted : April 21, 2009
Last Update Posted : January 26, 2010
|Condition or disease||Intervention/treatment||Phase|
|Overweight||Dietary Supplement: fish oil Dietary Supplement: olive oil||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Effect of Acute and Short-term Intervention With Fish Oil on Overweight Subjects - Focus on Inflammation|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||December 2009|
|Experimental: Fish oil||
Dietary Supplement: fish oil
Capsules. Approximately 1000 mg n-3 PUFA daily. One day + 6 weeks
|Placebo Comparator: Olive oil||
Dietary Supplement: olive oil
Capsules. Approximately 1 g olive oil daily. One day + 6 weeks
- To assess the effect of 1 g/day of n-3 polyunsaturated fatty acids on inflammatory markers [ Time Frame: After 1 day and after 6 weeks intervention ]
- To assess effect of 1 g n-3 polyunsaturated fatty acids (daily dose) on the fatty acid profile of plasma, leucocytes and adipose tissue. [ Time Frame: After 1 day and 6 after weeks of intervention ]
- 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. [ Time Frame: After 1 day and 6 after weeks of intervention ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00885053
|Aalborg Hospital, Aarhus University Hospital|
|Aalborg, Denmark, 9000|