Fish Oil and Inflammation in Overweight Subjects

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Acute and Short-term Intervention With Fish Oil on Overweight Subjects - Focus on Inflammation

Conditions
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Overweight

Intervention / Treatment
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* Dietary Supplement: fish oil
* Dietary Supplement: olive oil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fish oil<br> | Dietary Supplement: fish oil<br>* Capsules. Approximately 1000 mg n-3 PUFA daily. One day + 6 weeks<br>|
| Placebo Comparator: Olive oil<br> | Dietary Supplement: olive oil<br>* Capsules. Approximately 1 g olive oil daily. One day + 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the effect of 1 g/day of n-3 polyunsaturated fatty acids on inflammatory markers |  | After 1 day and after 6 weeks intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess effect of 1 g n-3 polyunsaturated fatty acids (daily dose) on the fatty acid profile of plasma, leucocytes and adipose tissue. |  | 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. |  | After 1 day and 6 after weeks of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammation, Fatty acids, Omega 3, Leukotrienes, Adiponectin, Adipose tissue, RNA, Messenger