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| Name | Class |
|---|---|
| Cherry Research Committee | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tart Cherry | Experimental | 12 weeks of tart cherry juice taken in two doses of 240 ml per day. |
|
| Placebo | Placebo Comparator | 12 weeks tart cherry juice taken in two doses of 240 ml per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tart Cherry | Dietary Supplement | 12 weeks of tart cherry juice taken in two doses of 240 ml per day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure | By measuring brachial and aortic blood pressure at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia). | 12 weeks |
| Arterial Stiffness | By measuring arterial stiffness and augmentation index at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia). | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Autonomic Control of Blood Pressure | By measuring blood pressure variability and baroreflex sensitivity at rest and during physiological stress. | 12 weeks |
| Endothelial Function | By measuring markers of endothelial function. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bahram H. Arjmandi, PhD, RD | Department of Nutrition, Food and Exercise Sciences, Center for Advancing Exercise and Nutrition Research on Aging, Florida State University | Principal Investigator |
| Arturo Figueroa, MD, PhD | Department of Nutrition, Food and Exercise Sciences, Florida State University | Principal Investigator |
| Sarah A. Johnson, PhD, RDN | Department of Food Science and Human Nutrition, Colorado State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nutrition, Food and Exercise Sciences, Center for Advancing Exercise and Nutrition Research on Aging, Florida State University | Tallahassee | Florida | 32306 | United States |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D002318 | Cardiovascular Diseases |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| Placebo | Dietary Supplement | 12 weeks of tart cherry juice taken in two doses of 240 ml per day. |
|
| 12 weeks |
| Endothelial-mediated Vasodilation | By measuring flow-mediated dilation in the brachial artery. | 12 weeks |
| Inflammation | By measuring a marker of inflammation. | 12 weeks |
| Oxidative Stress | By measuring markers of oxidative stress. | 12 weeks |
| Insulin Sensitivity | By measuring fasting glucose, insulin, and homeostatic model assessments of insulin resistance, sensitivity, and beta cell function. | 12 weeks |
| Atherogenic Markers | By measuring adhesion factors, lipid profiles, and atherogenic risk ratios. | 12 weeks |
| Body Composition | By measuring fat mass and fat-free mass using dual-energy X-ray absorptiometry and anthropometrics. | 12 weeks |
| D009750 |
| Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |