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Completed

NCT Number: NCT02154100

Tart Cherry, Metabolic Syndrome, and Cardiovascular Risk

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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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Nutrition, Food and Exercise Sciences, Center for Advancing Exercise and Nutrition Research on Aging, Florida State University

Tallahassee, Florida, 32306, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tart Cherry

Dietary Supplement

12 weeks of tart cherry juice taken in two doses of 240 ml per day.

Placebo

Dietary Supplement

12 weeks of tart cherry juice taken in two doses of 240 ml per day.

Primary outcomes

  1. Blood Pressure

    Time frame: 12 weeks

    By measuring brachial and aortic blood pressure at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).

  2. Arterial Stiffness

    Time frame: 12 weeks

    By measuring arterial stiffness and augmentation index at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).

Secondary outcomes

  1. Autonomic Control of Blood Pressure

    Time frame: 12 weeks

    By measuring blood pressure variability and baroreflex sensitivity at rest and during physiological stress.

  2. Endothelial Function

    Time frame: 12 weeks

    By measuring markers of endothelial function.

  3. Endothelial-mediated Vasodilation

    Time frame: 12 weeks

    By measuring flow-mediated dilation in the brachial artery.

  4. Inflammation

    Time frame: 12 weeks

    By measuring a marker of inflammation.

  5. Oxidative Stress

    Time frame: 12 weeks

    By measuring markers of oxidative stress.

  6. Insulin Sensitivity

    Time frame: 12 weeks

    By measuring fasting glucose, insulin, and homeostatic model assessments of insulin resistance, sensitivity, and beta cell function.

  7. Atherogenic Markers

    Time frame: 12 weeks

    By measuring adhesion factors, lipid profiles, and atherogenic risk ratios.

  8. Body Composition

    Time frame: 12 weeks

    By measuring fat mass and fat-free mass using dual-energy X-ray absorptiometry and anthropometrics.

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Collaborators

  • Cherry Research Committee

Registry information

Official study title

Tart Cherry Improves Cardiovascular Risk Factors Associated With Metabolic Syndrome

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 3, 2014
Registry last updated
Dec 8, 2016

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.

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