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临床试验/NCT02382471
NCT02382471已完成4 期

Assessing the Effects of Omega-3 Supplementation on Some Serum BDNF، Follistatin، Irisin Levels in Men With Coronary Artery Disease

Tehran University of Medical Sciences2 个研究点 分布在 2 个国家目标入组 21 人开始时间: 2011年12月最近更新:
适应症
干预措施

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

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

Placebo Comparator

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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