Fish Oil and Inflammation in Overweight Subjects - Full Text View

Purpose

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.

Condition	Intervention
Overweight	Dietary Supplement: fish oil Dietary Supplement: olive oil

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	The Effect of Acute and Short-term Intervention With Fish Oil on Overweight Subjects - Focus on Inflammation

Resource links provided by NLM:

Drug Information available for: Olive oil Fish oil

U.S. FDA Resources

Further study details as provided by Aalborg Universityhospital:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Enrollment:	50
Study Start Date:	April 2009
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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

Ages Eligible for Study:	30 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00885053

Locations

Denmark
Aalborg Hospital, Aarhus University Hospital
Aalborg, Denmark, 9000

Sponsors and Collaborators

Aalborg Universityhospital

More Information

Publications:

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. Epub 2008 Sep 5. Review.

Balkau B, Deanfield JE, Després 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.

Libby P, Ridker PM, Maseri A. Inflammation and atherosclerosis. Circulation. 2002 Mar 5;105(9):1135-43. Review.

Calder PC. n-3 polyunsaturated fatty acids, inflammation, and inflammatory diseases. Am J Clin Nutr. 2006 Jun;83(6 Suppl):1505S-1519S. Review.

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. Review.

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. Review. 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.

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. Review. No abstract available.

Responsible Party:	Trine Madsen / MD, Department of Cardiology, Aalborg Hospital, Aarhus University Hospital, Denmark
ClinicalTrials.gov Identifier:	NCT00885053 History of Changes
Other Study ID Numbers:	ADIPOMEGA
Study First Received:	April 20, 2009
Last Updated:	January 25, 2010
Health Authority:	Denmark: Danish Dataprotection Agency Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Aalborg Universityhospital:

Inflammation
Fatty acids, Omega 3
Leukotrienes

Adiponectin
Adipose tissue
RNA, Messenger

Additional relevant MeSH terms:

Inflammation
Overweight
Pathologic Processes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013

Fish Oil and Inflammation in Overweight Subjects (ADIPOMEGA)