Department of Nutrition, Food and Exercise Sciences, Center for Advancing Exercise and Nutrition Research on Aging, Florida State University
Tallahassee, Florida, 32306, United States
NCT Number: NCT02154100
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.
Looking for future studies?
Notify Me20 year–60 year
All sexes
Interventional
Phase 2
Tallahassee, Florida, 32306, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 12 weeks
By measuring brachial and aortic blood pressure at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).
Time frame: 12 weeks
By measuring arterial stiffness and augmentation index at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).
Time frame: 12 weeks
By measuring blood pressure variability and baroreflex sensitivity at rest and during physiological stress.
Time frame: 12 weeks
By measuring markers of endothelial function.
Time frame: 12 weeks
By measuring flow-mediated dilation in the brachial artery.
Time frame: 12 weeks
By measuring a marker of inflammation.
Time frame: 12 weeks
By measuring markers of oxidative stress.
Time frame: 12 weeks
By measuring fasting glucose, insulin, and homeostatic model assessments of insulin resistance, sensitivity, and beta cell function.
Time frame: 12 weeks
By measuring adhesion factors, lipid profiles, and atherogenic risk ratios.
Time frame: 12 weeks
By measuring fat mass and fat-free mass using dual-energy X-ray absorptiometry and anthropometrics.
Florida State University
Other
Tart Cherry Improves Cardiovascular Risk Factors Associated With Metabolic Syndrome
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03528031
Behavior, Behavior, Animal
Loma Linda, California, United States
View Trial DetailsNCT03543644
Body Weight, Cardiovascular Diseases
Toronto, Ontario, Canada
View Trial DetailsNCT03191227
Behavior, Behavior, Animal
View Trial DetailsNCT02358109
Behavior, Cardiovascular Diseases
Granada, Andalusia, Spain
View Trial Details