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Fish Oil and Inflammation in Overweight Subjects (ADIPOMEGA)

This study has been completed.
Information provided by:
Aalborg Universitetshospital Identifier:
First received: April 20, 2009
Last updated: January 25, 2010
Last verified: December 2009
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
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

Resource links provided by NLM:

Further study details as provided by Aalborg Universitetshospital:

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 ]

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 ]
  • 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 ]

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.


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

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
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Please refer to this study by its identifier: NCT00885053

Aalborg Hospital, Aarhus University Hospital
Aalborg, Denmark, 9000
Sponsors and Collaborators
Aalborg Universitetshospital
  More Information


Responsible Party: Trine Madsen / MD, Department of Cardiology, Aalborg Hospital, Aarhus University Hospital, Denmark Identifier: NCT00885053     History of Changes
Other Study ID Numbers: ADIPOMEGA
Study First Received: April 20, 2009
Last Updated: January 25, 2010

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

Additional relevant MeSH terms:
Pathologic Processes
Body Weight
Signs and Symptoms processed this record on August 23, 2017