Effect of Phenolic Acids on the Human Vasculature
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Efficacy by oral administration of phenolic acid in improving endothelial function
研究概览
简要总结
This study evaluates effects of different doses of phenolic acids on healthy volunteers.
详细描述
It has been suggested that consumption of food rich in phenolic acids can help to improve vascular health, measured by flow mediated dilation (FMD).
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 as 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 10 days before 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
- •Body mass index (BMI) outside 18-32 kg/m2 range
研究组 & 干预措施
86.6 mg hydrolyzed green coffee extract
hydrolyzed green coffee extract as interventions
干预措施: 86.6 mg hydrolyzed green coffee extract (Other)
Placebo
Placebo
干预措施: Placebo (Other)
43.3 mg hydrolyzed green coffee extract
hydrolyzed green coffee extract as interventions
干预措施: 43.3 mg hydrolyzed green coffee extract (Other)
173 mg hydrolyzed green coffee extract
hydrolyzed green coffee extract as interventions
干预措施: 173 mg hydrolyzed green coffee extract (Other)
结局指标
主要结局
Efficacy by oral administration of phenolic acid in improving endothelial function
时间窗: 6 hours
Average change from baseline in %FMD at any time point post treatment. Responses will be calculated as the percentage change in brachial artery diameter from baseline.
次要结局
- Elimination half-life(6 hours)
- Tmax(6 hours)
- AUC(Area Under Curve) of the concentration/time curve(6 hours)