Clinical trial NCT02154100: Tart Cherry, Metabolic Syndrome, and Cardiovascular Risk
Official title: Tart Cherry Improves Cardiovascular Risk Factors Associated With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metabolic Syndrome
Cardiovascular Diseases
Diabetes
Keywords: Metabolic Syndrome
Arterial Stiffness
Blood Pressure
Endothelial Function
Tart Cherries
Lead sponsor: Florida State University
Sponsor class: OTHER
Collaborators: name: Cherry Research Committee
First posted: 2014-06-03
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Blood Pressure
timeFrame: 12 weeks
measure: Arterial Stiffness
timeFrame: 12 weeks
Secondary outcomes:
measure: Autonomic Control of Blood Pressure
timeFrame: 12 weeks
measure: Endothelial Function
timeFrame: 12 weeks
measure: Endothelial-mediated Vasodilation
timeFrame: 12 weeks
measure: Inflammation
timeFrame: 12 weeks
measure: Oxidative Stress
timeFrame: 12 weeks
measure: Insulin Sensitivity
timeFrame: 12 weeks
measure: Atherogenic Markers
timeFrame: 12 weeks
measure: Body Composition
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Department of Nutrition, Food and Exercise Sciences, Center for Advancing Exercise and Nutrition Research on Aging, Florida State University
state: Florida
Study officials:
affiliation: Department of Nutrition, Food and Exercise Sciences, Center for Advancing Exercise and Nutrition Research on Aging, Florida State University
name: Bahram H. Arjmandi, PhD, RD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nutrition, Food and Exercise Sciences, Florida State University
name: Arturo Figueroa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Food Science and Human Nutrition, Colorado State University
name: Sarah A. Johnson, PhD, RDN
role: PRINCIPAL_INVESTIGATOR
References: