Tart Cherry, Metabolic Syndrome, and Cardiovascular Risk

Diabetes Clinical Trial

Official title:

Tart Cherry Improves Cardiovascular Risk Factors Associated With Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02154100
• Other study ID #: RF02406
• Status: Completed
• Phase: Phase 2
• First received: May 30, 2014
• Last updated: December 6, 2016
• Start date: April 2014
• Est. completion date: October 2016

Study information

• Verified date: December 2016
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes
• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Dietary Supplement:
• Tart Cherry
12 weeks of tart cherry juice taken in two doses of 240 ml per day.
• Placebo
12 weeks of tart cherry juice taken in two doses of 240 ml per day.

Locations

Country	Name	City	State
United States	Department of Nutrition, Food and Exercise Sciences, Center for Advancing Exercise and Nutrition Research on Aging, Florida State University	Tallahassee	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Florida State University	Cherry Research Committee

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure	By measuring brachial and aortic blood pressure at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).	12 weeks	No
Primary	Arterial Stiffness	By measuring arterial stiffness and augmentation index at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).	12 weeks	No
Secondary	Autonomic Control of Blood Pressure	By measuring blood pressure variability and baroreflex sensitivity at rest and during physiological stress.	12 weeks	No
Secondary	Endothelial Function	By measuring markers of endothelial function.	12 weeks	No
Secondary	Endothelial-mediated Vasodilation	By measuring flow-mediated dilation in the brachial artery.	12 weeks	No
Secondary	Inflammation	By measuring a marker of inflammation.	12 weeks	No
Secondary	Oxidative Stress	By measuring markers of oxidative stress.	12 weeks	No
Secondary	Insulin Sensitivity	By measuring fasting glucose, insulin, and homeostatic model assessments of insulin resistance, sensitivity, and beta cell function.	12 weeks	No
Secondary	Atherogenic Markers	By measuring adhesion factors, lipid profiles, and atherogenic risk ratios.	12 weeks	No
Secondary	Body Composition	By measuring fat mass and fat-free mass using dual-energy X-ray absorptiometry and anthropometrics.	12 weeks	No

External Links

•   Department of Nutrition, Food and Exercise Sciences, Florida State University