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Tart Cherry, Metabolic Syndrome, and Cardiovascular Risk

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Врската е зачувана во таблата со исечоци
СтатусЗавршено
Спонзори
Florida State University
Соработници
Cherry Research Committee

Клучни зборови

Апстракт

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.

Датуми

Последен пат проверено: 11/30/2016
Прво доставено: 05/29/2014
Поднесено е проценето запишување: 05/29/2014
Прво објавено: 06/02/2014
Последното ажурирање е доставено: 12/05/2016
Последно ажурирање објавено: 12/07/2016
Крај на датумот на започнување на студијата: 03/31/2014
Проценет датум на примарно завршување: 09/30/2016
Проценет датум на завршување на студијата: 09/30/2016

Состојба или болест

Metabolic Syndrome
Cardiovascular Diseases
Diabetes

Интервенција / третман

Dietary Supplement: Tart Cherry

Dietary Supplement: Placebo

Фаза

Фаза 2

Групи за раце

РакаИнтервенција / третман
Experimental: Tart Cherry
12 weeks of tart cherry juice taken in two doses of 240 ml per day.
Dietary Supplement: Tart Cherry
12 weeks of tart cherry juice taken in two doses of 240 ml per day.
Placebo Comparator: Placebo
12 weeks tart cherry juice taken in two doses of 240 ml per day.
Dietary Supplement: Placebo
12 weeks of tart cherry juice taken in two doses of 240 ml per day.

Критериуми за подобност

Возраст подобни за студии 20 Years До 20 Years
Полови квалификувани за студииAll
Прифаќа здрави волонтериДа
Критериуми

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

Исход

Мерки на примарниот исход

1. Blood Pressure [12 weeks]

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

2. Arterial Stiffness [12 weeks]

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

Секундарни мерки на исходот

1. Autonomic Control of Blood Pressure [12 weeks]

By measuring blood pressure variability and baroreflex sensitivity at rest and during physiological stress.

2. Endothelial Function [12 weeks]

By measuring markers of endothelial function.

3. Endothelial-mediated Vasodilation [12 weeks]

By measuring flow-mediated dilation in the brachial artery.

4. Inflammation [12 weeks]

By measuring a marker of inflammation.

5. Oxidative Stress [12 weeks]

By measuring markers of oxidative stress.

6. Insulin Sensitivity [12 weeks]

By measuring fasting glucose, insulin, and homeostatic model assessments of insulin resistance, sensitivity, and beta cell function.

7. Atherogenic Markers [12 weeks]

By measuring adhesion factors, lipid profiles, and atherogenic risk ratios.

8. Body Composition [12 weeks]

By measuring fat mass and fat-free mass using dual-energy X-ray absorptiometry and anthropometrics.

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