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Fish Oil and Inflammation in Overweight Subjects (ADIPOMEGA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00885053
First Posted: April 21, 2009
Last Update Posted: January 26, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Aalborg Universitetshospital
  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
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.

  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

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 Submitted: April 20, 2009
First Posted: April 21, 2009
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