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临床试验/NCT02154100
NCT02154100已完成2 期

Tart Cherry Improves Cardiovascular Risk Factors Associated With Metabolic Syndrome

Florida State University1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2014年4月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
26
试验地点
1
主要终点
Blood Pressure

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Placebo

Placebo Comparator

12 weeks tart cherry juice taken in two doses of 240 ml per day.

干预措施: Placebo (Dietary Supplement)

Tart Cherry

Experimental

12 weeks of tart cherry juice taken in two doses of 240 ml per day.

干预措施: Tart Cherry (Dietary Supplement)

结局指标

主要结局

Blood Pressure

时间窗: 12 weeks

By measuring brachial and aortic blood pressure at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).

Arterial Stiffness

时间窗: 12 weeks

By measuring arterial stiffness and augmentation index at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).

次要结局

  • Autonomic Control of Blood Pressure(12 weeks)
  • Endothelial Function(12 weeks)
  • Endothelial-mediated Vasodilation(12 weeks)
  • Inflammation(12 weeks)
  • Oxidative Stress(12 weeks)
  • Insulin Sensitivity(12 weeks)
  • Atherogenic Markers(12 weeks)
  • Body Composition(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bahram Arjmandi

Professor

Florida State University

研究点 (1)

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