Tart Cherry, Metabolic Syndrome, and Cardiovascular Risk
| Status: | Recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease, Endocrine |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology |
| Healthy: | No |
| Age Range: | 20 - 40 |
| Updated: | 4/21/2016 |
| Start Date: | April 2014 |
| Contact: | Sarah A. Johnson, PhD, RD, CSO |
| Email: | sba07@fsu.edu |
| Phone: | 850-644-4889 |
Tart Cherry Improves Cardiovascular Risk Factors Associated With Metabolic Syndrome
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.
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.
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
We found this trial at
1
site
Tallahassee, Florida 32306
Principal Investigator: Bahram H. Arjmandi, PhD, RD
Phone: 850-644-4889
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