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NCT02154100 · ClinicalTrials.gov registry record · Phase 2
Tart Cherry, Metabolic Syndrome, and Cardiovascular Risk
A Phase 2 study, sponsored by Florida State University.
- Completed
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
NCT02154100 is a Phase 2 study that has completed, run by Florida State University. The registered enrollment target is 26 participants.
The verdict
NCT02154100, a Phase 2 study, has completed, sponsored by Florida State University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
Study 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
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT Tart Cherry
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2014-04 |
| Est. Completion | 2016-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02154100
The ClinicalTrials.gov registry entry for NCT02154100 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Florida State University, which has 219 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02154100 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02154100 about?
NCT02154100 is a clinical study titled "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 cardi...
What is the current status of trial NCT02154100?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2014-04. Estimated completion is 2016-10.
What interventions are being tested in trial NCT02154100?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Tart Cherry (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT02154100?
This trial is sponsored by Florida State University, which has 219 total clinical trials registered on ClinicalTrials.gov.
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