The Effect of Acute and Short-term Intervention With Fish Oil on Overweight Subjects - Focus on Inflammation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- To assess the effect of 1 g/day of n-3 polyunsaturated fatty acids on inflammatory markers
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Waist circumference ≥ 80 cm (females) or ≥ 94 cm (males)
- •Postmenopausal (females)
排除标准
- •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
结局指标
主要结局
To assess the effect of 1 g/day of n-3 polyunsaturated fatty acids on inflammatory markers
时间窗: After 1 day and after 6 weeks intervention
次要结局
- 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)