Assessing the Effects of Omega-3 Supplementation on Some Serum BDNF، Follistatin، Irisin Levels in Men With Coronary Artery Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Serum Irisin
研究概览
简要总结
The aim of this study is the comparison between the effects of supplementation with omega 3 or placebo for 8 weeks in serum level of BDNF، Follistatin، Irisin in patients with cardiovascular disease.
详细描述
The aim of this study is the comparison between the effects of supplementation with omega 3 or placebo for 8 weeks in serum level of BDNF، Follistatin، Irisin in patients with cardiovascular disease. In this randomized, double-blind clinical trial, placebo-controlled, single-center, and phase two trials, 42men aged 45-65 years with Coronary Artery Disease are enrolled in the study from Tehran Heart Center. After signing informed consent all individuals complete a general information form , 24-hour food recall for 3 days will be taken from the participants at the beginning and the end of the study,. Selected samples are randomly classified into 2 blocks of groups receiving supplement and placebo. The supplement group, will receive 4 g/day omega 3 fatty acid for 8 weeks and the placebo group will also receive placebo (containing 4 g of edible paraffin) (similar in terms of color, shape and size). Patients are recommended to sustain their diets and medication dose (s) during the study and also advised to maintain a constant level of physical activity. Blood samples will be collected after 8-12 hours fasting and anthropometric variables, biochemical parameters and physical activity before and after the trial will be measured.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 65 Years(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •cardiovascular disease patients 45- 65 years old,
- •patients with ≥ 50% stenosis in at least one coronary angiogram demonstrated,
- •body mass index in the range 18.5- 35,
- •avoidance of dietary supplements, vitamins and herbal products at least 3 months before and throughout the intervention,
- •willingness to participation,
排除标准
- •people who have used omega 3 supplements in last 3 months,
- •having chronic renal disease ,
- •GI disease,
- •hepatobiliary diseases,
- •hematological disorders,
- •movement disorders,
- •myopathy ,
- •hypo- or hyperthyroidism,
研究组 & 干预措施
CVD, Placebo
patients with cardiovascular disease who receive 4 cap of placebo/day
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Serum Irisin
时间窗: Change from baseline at 2 months
Serum Myostatin
时间窗: Change from baseline at 2 months
Serum Brain-Derived Neurotrophic Factor(BDNF)
时间窗: Change from baseline at 2 months
Serum Follistatin
时间窗: Change frome baseline at 2 months
次要结局
- Serum high-sensitivity C-reactive protein (hsCRP)(Change from baseline at 2 months)
