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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
Sponsor:
Information provided by:
Aalborg Universitetshospital

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.

Condition or disease Intervention/treatment Phase
Overweight Dietary Supplement: fish oil Dietary Supplement: olive oil Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : April 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]


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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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


Locations
Denmark
Aalborg Hospital, Aarhus University Hospital
Aalborg, Denmark, 9000
Sponsors and Collaborators
Aalborg Universitetshospital

Publications:

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
First Posted: April 21, 2009    Key Record Dates
Last Update Posted: January 26, 2010
Last Verified: December 2009

Keywords provided by Aalborg Universitetshospital:
Inflammation
Fatty acids, Omega 3
Leukotrienes
Adiponectin
Adipose tissue
RNA, Messenger

Additional relevant MeSH terms:
Inflammation
Overweight
Pathologic Processes
Body Weight
Signs and Symptoms