NCT03464760已完成不适用
Evaluation of the Effect of Spirulina-Silicon Supplementation on the Morphological, Biomechanical and Functional Characteristics of the Arterial Wall in the Elderly
Centre Hospitalier Universitaire de Nīmes2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年1月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Arterial Pressure Waveforms between groups
研究概览
简要总结
The investigators hypothesize that spirulina-silicon supplementation will lead to an improvement in vasomotor endothelial function, followed by decreased arterial wave velocity on the aorta and central arterial pressure compared to placebo subjects.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject must have given their free and informed consent and signed the consent form
- •The subject must be a member or beneficiary of a health insurance plan
- •The subject is available for 6 months of follow-up
- •The subject must not have any pre-existing chronic illness nor any revealed during the pre-inclusion visit, either treated or requiring treatment according to current recommendations
排除标准
- •The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
- •The subject refuses to sign the consent
- •It is impossible to give the subject informed information
- •The patient is under safeguard of justice or state guardianship
- •Presence of a chronic cardio-vascular and/or metabolic illness, known or revealed by the pre-inclusion exam and requiring treatment in accordance to official recommendations (HAS)
- •Any other chronic pathology requiring medical treatment
- •History of uric acid metabolism disorders (hyperuricemia, gout, urolithiasis).
- •Subject presenting a loss of limitation of autonomy
- •Treated with hormone replacement therapy in females
- •Active smoker or drug user
- •Presence of an abnormality revealed by the pre-inclusion biological assessment of dyslipidemia justifying a prescription medication, diabetes or intolerance to glucose (insulin resistance).
- •Presence of a stenosis (greater than 50% in diameter, NASCET method) or carotid occlusion revealed by the echo-Doppler screening test.
- •Presence of an aneurysm (dilation> 30 mm) of the abdominal aorta revealed by the echo-Doppler screening test.
- •Arteriopathy of the lower limbs (toe systolic pressure (tsp) <0.7) revealed by the screening test (SysToe™ device).
- •Subject already taking a food supplement based on spirulina or silicon.
- •History of cardio-vascular disease or heart attack
- •Subject develops a chronic illness requiring medical treatment for more than 7 days or a surgical intervention leading to incapacity for more than 7 days,or a pathological event during the 14-day period before each follow-up visit, or a serious adverse event
结局指标
主要结局
Arterial Pressure Waveforms between groups
时间窗: Month 6
Applanation tonometry; m.s-1
次要结局
- Vasomotor endothelial function of females compared to males(Month 6)
- Biological markers of vascular remodeling, oxidative stress and inflammation(Month 6)
- intima-media thickness of common carotid arteries(Month 6)
- Central venous pressure(Month 6)
- Arterial Pressure Waveforms of females compared to males(Month 6)
- Vasomotor endothelial function between groups(Month 6)
- left ventricular diastolic function(Month 6)
- Bone density(Month 6)
- Arterial Pressure Waveforms between groups(Month 3)
研究者
研究点 (2)
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