Fish Oil and Inflammation in Overweight Subjects (ADIPOMEGA)

Aalborg University Hospital

Status: Completed

Conditions: Overweight

Treatments: Dietary Supplement: olive oil; Dietary Supplement: fish oil

Study type: Interventional

Funder types: Other

Identifiers

NCT00885053

ADIPOMEGA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Fish oil

Experimental group

Treatment:

Dietary Supplement: fish oil

Olive oil

Placebo Comparator group

Treatment:

Dietary Supplement: olive oil