Fish Oil and Inflammation in Overweight Subjects (ADIPOMEGA)

This study has been completed.
Sponsor:
Information provided by:
Aalborg Universitetshospital
ClinicalTrials.gov Identifier:
NCT00885053
First received: April 20, 2009
Last updated: January 25, 2010
Last verified: December 2009
  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:


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 ] [ 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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
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 Universitetshospital:
Inflammation
Fatty acids, Omega 3
Leukotrienes
Adiponectin
Adipose tissue
RNA, Messenger

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

ClinicalTrials.gov processed this record on October 22, 2014