The Effects of Fish Oil Supplements During Supervised Exercise Therapy in Patients With Intermittent Claudication
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Maximal walking distance with standardised treadmill test
研究概览
简要总结
Intermittent claudication (IC) is caused by peripheral arterial disease and has a high morbidity and mortality. Etiologic factors are similar to those of cardiovascular disease. Primary treatment consists of cardiovascular risk management and improvement of functional capacity with supervised exercise therapy (SET). A potential additional therapy is the administration of fish oil supplements containing high amounts of omega-3 Poly Unsaturated Fatty Acids (PUFAs). In earlier clinical and experimental trials omega-3 PUFA's improved hemorheological parameters such as erythrocyte deformability and aggregation, and a number of cardiovascular risk factors. Hemorheological parameters determine the blood flow in the microcirculation, which is of main importance in patients with IC since the macrocirculation is compromised. Inflammation is considered an important etiologic factor in the pathogenesis of atherosclerosis and contributes to peripheral arterial disease Since omega-3 PUFAs also have a strong anti-inflammatory effect, they might be effective in patients with IC by lowering the inflammatory response. In addition, visceral fat rather than obesity in general has been recognised as an etiologic and prognostic factor in atherosclerosis.
We hypothesise that the administration of omega-3 PUFA's in patients with IC has a synergistic effect with SET and improves walking distance after SET, by improving hemorheological parameters resulting in a better microcirculation. Second, we hypothesise that omega-3 PUFA's result in a less proinflammatory of whole blood in response to ex vivo stimulation with endotoxin. Third, we hypothesise that omega-3 PUFA's and SET result in a decrease in visceral fat mass.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed intermittent claudication
- •Ankle Brachial Index < 0.8 at rest or > 0.15 decrease after exercise
- •Able to perform standardised treadmill walking test for 2 min
- •Written informed consent
排除标准
- •Unable to fill out a questionnaire (cognitive impairment or insufficient knowledge of the Dutch language)
- •Heart failure or unstable cardiac status (angina pectoris class III or IV or recent myocardial infarction < 3 months)
- •Any illness with rapid evolution or a life expectancy < 3 months
- •Recent cerebrovascular accident (< 3 months)
- •Current use of fish oil supplements or > 2 times a week dietary fish
- •Pregnancy
- •Fish, soybean or peanut allergy
- •Contra indications for the use of omega-3 fatty acids
- •Use of oral anticoagulants (coumarin derivatives)
研究组 & 干预措施
Supervised Exercise Therapy
Standard treatment: Supervised Exercise Therapy during 12 weeks
干预措施: Omega-3 fatty acids (Drug)
结局指标
主要结局
Maximal walking distance with standardised treadmill test
时间窗: After 12 weeks of supervised exercise therapy
次要结局
- Hemorheological parameters(After 12 weeks of supervised exercise therapy)
- Ex vivo cytokine production after stimulation with lipopolysaccharide(After 12 weeks of supervised exercise therapy)
- Assessment of the microcirculation with side stream dark field technology(After 12 weeks of supervised exercise therapy)
- Visceral fat mass(After 12 weeks of supervised exercise therapy)
研究者
Alexander P.J. Houdijk
Dr.
Medical Center Alkmaar