Tart Cherry, Metabolic Syndrome, and Cardiovascular Risk
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ClinicalTrials.gov Identifier: NCT02154100 |
Recruitment Status :
Completed
First Posted : June 3, 2014
Last Update Posted : December 8, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Metabolic Syndrome Cardiovascular Diseases Diabetes | Dietary Supplement: Tart Cherry Dietary Supplement: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 26 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Tart Cherry Improves Cardiovascular Risk Factors Associated With Metabolic Syndrome |
Study Start Date : | April 2014 |
Actual Primary Completion Date : | October 2016 |
Actual Study Completion Date : | October 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: Tart Cherry
12 weeks of tart cherry juice taken in two doses of 240 ml per day.
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Dietary Supplement: Tart Cherry
12 weeks of tart cherry juice taken in two doses of 240 ml per day. |
Placebo Comparator: Placebo
12 weeks tart cherry juice taken in two doses of 240 ml per day.
|
Dietary Supplement: Placebo
12 weeks of tart cherry juice taken in two doses of 240 ml per day. |
- 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).
- 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).
- Autonomic Control of Blood Pressure [ Time Frame: 12 weeks ]By measuring blood pressure variability and baroreflex sensitivity at rest and during physiological stress.
- Endothelial Function [ Time Frame: 12 weeks ]By measuring markers of endothelial function.
- Endothelial-mediated Vasodilation [ Time Frame: 12 weeks ]By measuring flow-mediated dilation in the brachial artery.
- Inflammation [ Time Frame: 12 weeks ]By measuring a marker of inflammation.
- Oxidative Stress [ Time Frame: 12 weeks ]By measuring markers of oxidative stress.
- Insulin Sensitivity [ Time Frame: 12 weeks ]By measuring fasting glucose, insulin, and homeostatic model assessments of insulin resistance, sensitivity, and beta cell function.
- Atherogenic Markers [ Time Frame: 12 weeks ]By measuring adhesion factors, lipid profiles, and atherogenic risk ratios.
- Body Composition [ Time Frame: 12 weeks ]By measuring fat mass and fat-free mass using dual-energy X-ray absorptiometry and anthropometrics.

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Ages Eligible for Study: | 20 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02154100
United States, Florida | |
Department of Nutrition, Food and Exercise Sciences, Center for Advancing Exercise and Nutrition Research on Aging, Florida State University | |
Tallahassee, Florida, United States, 32306 |
Principal Investigator: | Bahram H. Arjmandi, PhD, RD | Department of Nutrition, Food and Exercise Sciences, Center for Advancing Exercise and Nutrition Research on Aging, Florida State University | |
Principal Investigator: | Arturo Figueroa, MD, PhD | Department of Nutrition, Food and Exercise Sciences, Florida State University | |
Principal Investigator: | Sarah A. Johnson, PhD, RDN | Department of Food Science and Human Nutrition, Colorado State University |
Responsible Party: | Bahram Arjmandi, Professor, Florida State University |
ClinicalTrials.gov Identifier: | NCT02154100 |
Other Study ID Numbers: |
RF02406 |
First Posted: | June 3, 2014 Key Record Dates |
Last Update Posted: | December 8, 2016 |
Last Verified: | December 2016 |
Metabolic Syndrome Arterial Stiffness Blood Pressure Endothelial Function Tart Cherries |
Cardiovascular Diseases Metabolic Syndrome Syndrome Disease Pathologic Processes |
Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |