NCT03520452已完成不适用
Effect of Chlorogenic Acids on the Human Vasculature
Société des Produits Nestlé (SPN)2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2018年3月14日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Efficacy by oral administration of chlorogenic acid in improving endothelial function
研究概览
简要总结
This study evaluates effects of different doses of chlorogenic acids on vascular health.
详细描述
It has been suggested that consumption of food rich in chlorogenic acids can help to improve vascular health, measured by flow mediated dilation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or postmenopausal female healthy volunteers aged 45-65 years old
- •Willing and able to sign written informed consent prior to trial entry
- •Healthy as determined by the medical history and physical examination
排除标准
- •Premenopausal women
- •Current smokers
- •Abnormal blood pressure, defined as follow: systolic <90 or >140 mmHg and diastolic <60 or >90 mmHg
- •Regular consumption of cholesterol-lowering medication
- •Regular consumption of antihypertensive medication
- •Regular consumption of any vasoactive medication that cannot be discontinued for at least 4 half-lives before the FMD assessment
- •Any food allergies
- •Any intakes of multivitamin-tablets and other supplemental compounds within 10 days of the study start and throughout the study
- •Inability to refrain from coffee/tea and alcohol consumption for 12 h prior to study visits
- •Acute or chronic major psychiatric illness or other major illness that in the opinion of the investigator would make the subjects' participation in the study unsafe or prevent them from fully complying with the study procedures
- •Use of medication to treat psychiatric illness (depression) within 3 months prior to the study
- •Recent significant weight loss or gain (>6% of body weight) in the past 3 months
- •Body mass index (BMI) outside 18-32 kg/m2 range
- •Alcohol intake > 280g/week (21-28 glasses per week)
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Other)
302 mg green coffee extract
Experimental
Green coffee extract
干预措施: Green coffee extract (Other)
604 mg green coffee extract
Experimental
Green coffee extract
干预措施: Green coffee extract (Other)
906 mg green coffee extract
Experimental
Green coffee extract
干预措施: Green coffee extract (Other)
结局指标
主要结局
Efficacy by oral administration of chlorogenic acid in improving endothelial function
时间窗: 24 hours
The primary outcome will be the average change from baseline (i.e. predose) in the %Flow Mediated Dilation
次要结局
- Tmax(24 hours)
- Cmax of the different chlorogenic acid metabolites(24 hours)
- Area Under Curve of the concentration/time curve(24 hours)
- elimination half-life.(24 hours)
研究者
研究点 (2)
Loading locations...
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