Effects of Novel Coconut Inflorescence Sap (CSP; COCOZEN) on Age-related Cardiovascular Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change in systolic and diastolic brachial blood pressure
研究概览
简要总结
The goal of this intervention is to determine the efficacy of coconut sap powder (CSP) to lower arterial stiffness and blood pressure in middle-aged and older adults. Participants will be randomized to the CSP arm or Placebo arm of the study. Primary endpoints include: aortic stiffness assessed by carotid-femoral pulse wave velocity, resting brachial and (non-invasive) carotid blood pressure, and carotid stiffness (e.g. Beta stiffness index, Carotid compliance, Elastic modulus, Distensibility).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index 18-35 kg/m2
- •Brachial blood pressure <140/90
- •Nonsmoker
- •No known clinical disease, or suggestive signs or symptoms of clinical disease
- •Free of alcohol or drug dependence
排除标准
- •taking any anti-hypertensive, lipid lowering or other cardiovascular altering medications
- •Known allergies to coconut or tree nuts (i.e., cashews, almonds, or pistachios)
- •Engaging in vigorous intensity exercise
研究组 & 干预措施
Placebo
Capsules containing aspartame (1.5 g/day) were taken orally once daily for 8 weeks.
干预措施: Placebo (Dietary Supplement)
Coconut Sap Powder
Capsules containing coconut sap powder (CSP; 1.5 g/day) were taken orally once daily for 8 weeks.
干预措施: Coconut Sap Powder (CSP) (Dietary Supplement)
结局指标
主要结局
Change in systolic and diastolic brachial blood pressure
时间窗: Baseline and 8 weeks
Manual sphygmomanometer (mmHg)
Change in carotid artery stiffness - beta stiffness index
时间窗: Baseline and 8 weeks
Carotid artery Beta stiffness index (AU)
Change in carotid systolic and diastolic blood pressure
时间窗: Baseline and 8 weeks
Applanation tonometry of carotid artery (mmHg)
Change in carotid artery stiffness - distensibility
时间窗: Baseline and 8 weeks
Carotid artery distensibility (10\^-3/kilopascals)
Change in aortic stiffness
时间窗: Baseline and 8 weeks
Carotid-femoral pulse wave velocity (meters/second)
Change in carotid artery stiffness - carotid compliance
时间窗: Baseline and 8 weeks
Carotid artery carotid compliance (mmHg/mm\^2)
Change in carotid artery stiffness - elastic modulus
时间窗: Baseline and 8 weeks
Carotid artery elastic modulus (kilopascals, kPa)
Change in carotid artery stiffness - Young's modulus
时间窗: Baseline and 8 weeks
Carotid artery Young's modulus (kilopascals, kPa)
次要结局
- Change in inflammatory biomarker - tumor necrosis factor alpha(Baseline and 8 weeks)
- Change in inflammatory biomarker - high sensitivity C-reactive protein(Baseline and 8 weeks)
- Change in oxidative stress biomarkers - Catalase(Baseline and 8 weeks)
- Change in oxidative stress biomarkers - Oxidized low density lipoprotein(Baseline and 8 weeks)
- Change in inflammatory biomarker - interleukin 6(Baseline and 8 weeks)
- Change in inflammatory biomarker - interleukin 10(Baseline and 8 weeks)
- Change in inflammatory biomarker - interleukin 1 beta(Baseline and 8 weeks)
- Change in inflammatory biomarker - monocyte chemoattractant protein 1(Baseline and 8 weeks)
- Change in oxidative stress biomarkers - superoxide dismutase(Baseline and 8 weeks)
研究者
Brad Fleenor
Associate Professor
Ball State University