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Tart Cherry, Metabolic Syndrome, and Cardiovascular Risk

Primary Purpose

Metabolic Syndrome, Cardiovascular Diseases, Diabetes

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tart Cherry
Placebo
Sponsored by
Florida State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring Metabolic Syndrome, Arterial Stiffness, Blood Pressure, Endothelial Function, Tart Cherries

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tart Cherry

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Blood Pressure
By measuring brachial and aortic blood pressure at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).
Arterial Stiffness
By measuring arterial stiffness and augmentation index at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).

Secondary Outcome Measures

Autonomic Control of Blood Pressure
By measuring blood pressure variability and baroreflex sensitivity at rest and during physiological stress.
Endothelial Function
By measuring markers of endothelial function.
Endothelial-mediated Vasodilation
By measuring flow-mediated dilation in the brachial artery.
Inflammation
By measuring a marker of inflammation.
Oxidative Stress
By measuring markers of oxidative stress.
Insulin Sensitivity
By measuring fasting glucose, insulin, and homeostatic model assessments of insulin resistance, sensitivity, and beta cell function.
Atherogenic Markers
By measuring adhesion factors, lipid profiles, and atherogenic risk ratios.
Body Composition
By measuring fat mass and fat-free mass using dual-energy X-ray absorptiometry and anthropometrics.

Full Information

First Posted
May 30, 2014
Last Updated
December 6, 2016
Sponsor
Florida State University
Collaborators
Cherry Research Committee
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1. Study Identification

Unique Protocol Identification Number
NCT02154100
Brief Title
Tart Cherry, Metabolic Syndrome, and Cardiovascular Risk
Official Title
Tart Cherry Improves Cardiovascular Risk Factors Associated With Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University
Collaborators
Cherry Research Committee

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Cardiovascular Diseases, Diabetes
Keywords
Metabolic Syndrome, Arterial Stiffness, Blood Pressure, Endothelial Function, Tart Cherries

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tart Cherry
Arm Type
Experimental
Arm Description
12 weeks of tart cherry juice taken in two doses of 240 ml per day.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
12 weeks tart cherry juice taken in two doses of 240 ml per day.
Intervention Type
Dietary Supplement
Intervention Name(s)
Tart Cherry
Intervention Description
12 weeks of tart cherry juice taken in two doses of 240 ml per day.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
12 weeks of tart cherry juice taken in two doses of 240 ml per day.
Primary Outcome Measure Information:
Title
Blood Pressure
Description
By measuring brachial and aortic blood pressure at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).
Time Frame
12 weeks
Title
Arterial Stiffness
Description
By measuring arterial stiffness and augmentation index at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Autonomic Control of Blood Pressure
Description
By measuring blood pressure variability and baroreflex sensitivity at rest and during physiological stress.
Time Frame
12 weeks
Title
Endothelial Function
Description
By measuring markers of endothelial function.
Time Frame
12 weeks
Title
Endothelial-mediated Vasodilation
Description
By measuring flow-mediated dilation in the brachial artery.
Time Frame
12 weeks
Title
Inflammation
Description
By measuring a marker of inflammation.
Time Frame
12 weeks
Title
Oxidative Stress
Description
By measuring markers of oxidative stress.
Time Frame
12 weeks
Title
Insulin Sensitivity
Description
By measuring fasting glucose, insulin, and homeostatic model assessments of insulin resistance, sensitivity, and beta cell function.
Time Frame
12 weeks
Title
Atherogenic Markers
Description
By measuring adhesion factors, lipid profiles, and atherogenic risk ratios.
Time Frame
12 weeks
Title
Body Composition
Description
By measuring fat mass and fat-free mass using dual-energy X-ray absorptiometry and anthropometrics.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bahram H. Arjmandi, PhD, RD
Organizational Affiliation
Department of Nutrition, Food and Exercise Sciences, Center for Advancing Exercise and Nutrition Research on Aging, Florida State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arturo Figueroa, MD, PhD
Organizational Affiliation
Department of Nutrition, Food and Exercise Sciences, Florida State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sarah A. Johnson, PhD, RDN
Organizational Affiliation
Department of Food Science and Human Nutrition, Colorado State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nutrition, Food and Exercise Sciences, Center for Advancing Exercise and Nutrition Research on Aging, Florida State University
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32306
Country
United States

12. IPD Sharing Statement

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Tart Cherry, Metabolic Syndrome, and Cardiovascular Risk

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