Fish Oil and Inflammation in Overweight Subjects (ADIPOMEGA)
Primary Purpose
Overweight
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
fish oil
olive oil
Sponsored by

About this trial
This is an interventional prevention trial for Overweight focused on measuring Inflammation, Fatty acids, Omega 3, Leukotrienes, Adiponectin, Adipose tissue, RNA, Messenger
Eligibility 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
Sites / Locations
- Aalborg Hospital, Aarhus University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Fish oil
Olive oil
Arm Description
Outcomes
Primary Outcome Measures
To assess the effect of 1 g/day of n-3 polyunsaturated fatty acids on inflammatory markers
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.
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.
Full Information
NCT ID
NCT00885053
First Posted
April 20, 2009
Last Updated
January 25, 2010
Sponsor
Aalborg University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00885053
Brief Title
Fish Oil and Inflammation in Overweight Subjects
Acronym
ADIPOMEGA
Official Title
The Effect of Acute and Short-term Intervention With Fish Oil on Overweight Subjects - Focus on Inflammation
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Aalborg University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
Inflammation, Fatty acids, Omega 3, Leukotrienes, Adiponectin, Adipose tissue, RNA, Messenger
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fish oil
Arm Type
Experimental
Arm Title
Olive oil
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
fish oil
Intervention Description
Capsules. Approximately 1000 mg n-3 PUFA daily. One day + 6 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
olive oil
Intervention Description
Capsules. Approximately 1 g olive oil daily. One day + 6 weeks
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Aalborg Hospital, Aarhus University Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
18775919
Citation
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. doi: 10.1093/eurheartj/ehn387. Epub 2008 Sep 5.
Results Reference
background
PubMed Identifier
17965405
Citation
Balkau B, Deanfield JE, Despres 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. doi: 10.1161/CIRCULATIONAHA.106.676379.
Results Reference
background
PubMed Identifier
11877368
Citation
Libby P, Ridker PM, Maseri A. Inflammation and atherosclerosis. Circulation. 2002 Mar 5;105(9):1135-43. doi: 10.1161/hc0902.104353.
Results Reference
background
PubMed Identifier
16841861
Citation
Calder PC. n-3 polyunsaturated fatty acids, inflammation, and inflammatory diseases. Am J Clin Nutr. 2006 Jun;83(6 Suppl):1505S-1519S. doi: 10.1093/ajcn/83.6.1505S.
Results Reference
background
PubMed Identifier
15617737
Citation
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. doi: 10.1016/j.thromres.2004.09.006.
Results Reference
background
PubMed Identifier
15668184
Citation
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. doi: 10.1016/j.thromres.2004.09.007. No abstract available.
Results Reference
background
PubMed Identifier
17199721
Citation
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. doi: 10.1111/j.1463-1326.2006.00576.x.
Results Reference
background
PubMed Identifier
12588750
Citation
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. doi: 10.1161/01.atv.0000057393.97337.ae. No abstract available.
Results Reference
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Fish Oil and Inflammation in Overweight Subjects
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