Tart Cherry, Metabolic Syndrome, and Cardiovascular Risk
2016年12月6日 更新者:Bahram Arjmandi、Florida State University
Tart Cherry Improves Cardiovascular Risk Factors Associated With Metabolic Syndrome
The hypothesis of this study is that the daily consumption of 480 ml tart cherry juice for twelve weeks will improve blood pressure and arterial stiffness by improving endothelial-mediated vasodilation and vascular sympathetic activity and favorably altering biochemical markers associated with cardiovascular risk.
28 men and women between the ages of 20 and 40 who have three of the five features of metabolic syndrome as defined by the Adult Treatment Panel III will be included in the study.
After a two-week run-in phase, eligible men and women will be randomly assigned to one of two treatment groups: 1) 480 ml tart cherry juice or 2) 480 ml control drink daily for twelve weeks.
After an initial telephone screening, all participants will be requested to report to the study site for their first visit.
On the first visit (screening), participants will be provided with verbal and written explanation of the project.
They will then be asked to sign an informed consent form, followed by measuring waist circumference, resting brachial blood pressure, fasting serum triglycerides, high density lipoprotein cholesterol, and glucose levels to confirm metabolic syndrome.
Baseline assessments will be performed for medical history, medication use, dietary intake, and physical activity.
Qualified participants will be scheduled for their second visit two weeks later (actual baseline data collection) and randomly assigned to their treatment group.
On the second (baseline) visit between the hours of 7-10 A.M., blood pressure and vascular function will be measured followed by blood draw.
Anthropometrics will be measured.
Participants will be provided with their assigned treatment and will receive standard instructions on how to fill out daily diaries for their treatment, and for food and physical activity records.
Blood pressure, vascular function, blood draw, and anthropometric, body composition, diet, and physical activity assessments will be repeated at 6- (third visit), and 12-week (final visit) intervals.
All cardiovascular measurements will be performed between 7:00 to 10:00 A.M., in a quiet temperature-controlled room in the supine position after an overnight fast and 12 hours after the abstinence of caffeine and/or 24 hours after the last bout of moderate to heavy physical activity.
研究概览
研究类型
介入性
注册 (实际的)
26
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Florida
-
Tallahassee、Florida、美国、32306
- Department of Nutrition, Food and Exercise Sciences, Center for Advancing Exercise and Nutrition Research on Aging, Florida State University
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
20年 至 60年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Three of the following five features at the screening visit:
- Waist circumference of ≥ 40 inches for men and 35 inches for women
- Serum triglycerides ≥ 150 mg/dL
- Serum high density lipoprotein cholesterol levels < 40 mg/dL for men and <50 mg/dL for women
- Blood pressure ≥ 130/85 mm Hg
- Fasting blood glucose level ≥ 110 mg/dL
Exclusion Criteria:
- Taking hypoglycemic, antihypertensive or cholesterol-lowering medications
- Diagnosed cardiovascular disease
- Uncontrolled hypertension (≥ 160/100 mmHg)
- Diabetes mellitus
- Other active chronic diseases such as cancer, asthma, glaucoma, thyroid, kidney, liver and pancreatic disease
- Participating in a weight loss program
- Heavy smokers (> 20 cigarettes per day)
- Heavy drinkers (> 12 alcoholic drinks per week)
- Abnormal menstrual cycle
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Tart Cherry
12 weeks of tart cherry juice taken in two doses of 240 ml per day.
|
12 weeks of tart cherry juice taken in two doses of 240 ml per day.
|
|
安慰剂比较:Placebo
12 weeks tart cherry juice taken in two doses of 240 ml per day.
|
12 weeks of tart cherry juice taken in two doses of 240 ml per day.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
血压
大体时间:12周
|
通过测量静息和生理压力(握力运动和运动后肌肉缺血)时的肱动脉和主动脉血压。
|
12周
|
|
动脉硬化
大体时间:12周
|
通过测量静息和生理压力(握力运动和运动后肌肉缺血)时的动脉硬度和增强指数。
|
12周
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
氧化应激
大体时间:12周
|
通过测量氧化应激的标志物。
|
12周
|
|
身体构成
大体时间:12周
|
通过使用双能 X 射线吸收测定法和人体测量学测量脂肪量和去脂量。
|
12周
|
|
自主控制血压
大体时间:12周
|
通过测量静息和生理压力期间的血压变异性和压力反射敏感性。
|
12周
|
|
内皮介导的血管舒张
大体时间:12周
|
通过测量肱动脉中的流量介导的扩张。
|
12周
|
|
致动脉粥样化标志物
大体时间:12周
|
通过测量粘附因子、脂质分布和致动脉粥样硬化风险比。
|
12周
|
|
Endothelial Function
大体时间:12 weeks
|
By measuring markers of endothelial function.
|
12 weeks
|
|
Inflammation
大体时间:12 weeks
|
By measuring a marker of inflammation.
|
12 weeks
|
|
Insulin Sensitivity
大体时间:12 weeks
|
By measuring fasting glucose, insulin, and homeostatic model assessments of insulin resistance, sensitivity, and beta cell function.
|
12 weeks
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Sarah A. Johnson, PhD, RDN、Department of Food Science and Human Nutrition, Colorado State University
- 首席研究员:Bahram H. Arjmandi, PhD, RD、Department of Nutrition, Food and Exercise Sciences, Center for Advancing Exercise and Nutrition Research on Aging, Florida State University
- 首席研究员:Arturo Figueroa, MD, PhD、Department of Nutrition, Food and Exercise Sciences, Florida State University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年4月1日
初级完成 (实际的)
2016年10月1日
研究完成 (实际的)
2016年10月1日
研究注册日期
首次提交
2014年5月30日
首先提交符合 QC 标准的
2014年5月30日
首次发布 (估计)
2014年6月3日
研究记录更新
最后更新发布 (估计)
2016年12月8日
上次提交的符合 QC 标准的更新
2016年12月6日
最后验证
2016年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.