NCT01412216终止2 期
The Effects of Sedentarism on Vascular Function, Inflammation, and Insulin Resistance
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Endothelial Function
研究概览
简要总结
The purpose of this study are twofold:
- To understand the effects of physical inactivity (sedentarism) on vascular function, insulin resistance and inflammation;
- To assess the role of a dietary intervention (fish oil) in counteracting the effects of physical inactivity on vascular function and inflammation.
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
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects: Subjects must be free from any acute, chronic or debilitating medical conditions. Healthy status will be established on the basis of clinical history, electrocardiogram, clinical biochemical screening tests of blood and urine, a physical examination, and where necessary a chest radiograph.
排除标准
- •Any active acute or chronic medical problem: Any subject with symptoms of active illness (e.g., fever, leukocytosis, hypertension) will be excluded from study. The exclusion criteria will also include history or evidence for psychiatric disorders, hypertension, diabetes, coronary artery disease (CAD), renal insufficiency, thyroid disease, alcohol or drug abuse, viral hepatitis, deep venous thrombosis or anemia. Individuals with a history of psychiatric illnesses or psychiatric disorders will also be excluded, such as alcoholism, drug dependency including dependency on tobacco, major mood disorders such as major depression and manic depressive illness, schizophrenic disorders, anxiety disorders including panic disorder, generalized anxiety disorder, post traumatic stress disorder, obsessive compulsive disorder, agoraphobia, claustrophobia, paranoid personality disorder, schizoid personality disorder, schizotypal personality disorder, borderline personality disorder, and antisocial personality disorder. In addition, potential subjects with a first order relative with a history of major depressive illness, manic depressive illness, schizophrenia, agoraphobia or panic disorder will also be excluded from entry to this study. Finally, individuals who are unaware of specific psychiatric diagnoses who have a history of having been treated with antidepressant, neuroleptic medications or major tranquilizers will be excluded from study. However, a personal history of limited prior counseling or psychotherapy (e.g., for adjustment reactions) will not necessarily be exclusionary.
研究组 & 干预措施
Fish Oil (Omega-3 Fatty Acids)
Experimental
High-dose, short-duration dietary omega-3 fatty acids supplementation
干预措施: Fish Oil (Omega-3 Fatty Acids) (Dietary Supplement)
Placebo
Placebo Comparator
Placebo control
干预措施: Fish Oil (Omega-3 Fatty Acids) (Dietary Supplement)
结局指标
主要结局
Endothelial Function
时间窗: 5 days
Flow-mediated, brachial artery vasodilation (FMD)
次要结局
- Insulin Resistance(5 days)
研究者
研究点 (1)
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