Tart Cherry, Metabolic Syndrome, and Cardiovascular Risk
Condition: Metabolic Syndrome; Cardiovascular Diseases; Diabetes
MeSH terms: Cardiovascular Diseases; Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    


Intervention name(s): Tart Cherry; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Metabolic Syndrome; Arterial Stiffness; Blood Pressure; Endothelial Function; Tart Cherries