Fish Oil and Inflammation in Overweight Subjects

Not Applicable

Completed

• Conditions: Overweight
• Interventions: Dietary Supplement: fish oil; Dietary Supplement: olive oil

• Registration Number: NCT00885053
• Lead Sponsor: Aalborg University Hospital

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.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-20
• Study First Submitted QC: 2009-04-20
• Study First Posted: 2009-04-21
• Status Verified: 2009-12
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Last Update Submitted: 2010-01-25
• Last Update Posted: 2010-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fish oil	fish oil	-
Olive oil	olive oil	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Aalborg Hospital, Aarhus University Hospital; 🇩🇰 Aalborg, Denmark