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This study is intended to study the effects of one-time acute dosing of a solid extract of Passiflora incarnata, also known as Passionflower, on blood pressure and heart rate in students. Our hypothesis is that blood pressure levels and heart rates will decrease significantly in response to Passiflora incarnata.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Group | No Intervention | (a) Baseline blood pressure readings and one heart rate reading taken after at least 5 minutes of rest time without talking, eating, or caffeine consumption. b) will be given 1/4 tsp of blackstrap molasses placebo. Subjects may not consume caffeine or eat food during this time. (c) blood pressure readings and one heart rate will be taken 15 minutes after the baseline reading. | |
| Group II | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Passiflora incarnata | Dietary Supplement | One-time administration of 1/8 tsp solid extract Passiflora incarnata providing 900mg of Passiflora incarnata |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood pressure between baseline and 15 minutes | Change in blood pressure between baseline and 15 minutes | 15 minutes |
| Change in heart rate between baseline and 15 minutes | Change in heart rate between baseline and 15 minutes | 15 minutes |
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Inclusion Criteria: all University of Bridgeport students are invited to participate
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kimberly Sanders, ND | Contact | 2035764425 | kimbersa@bridgeport.edu | |
| Mark Mattie, MD, PhD | Contact | mmattie@bridgeport.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kimberly Sanders, ND | University of Bridgeport | Principal Investigator |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 28, 2019 | May 14, 2019 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 28, 2019 | May 14, 2019 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013610 | Tachycardia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
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There are two arms. One arm involves consuming a placebo. The second arm involves taking the Passionflower. Neither the primary investigator nor the participant will know which treatment they are taking.
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |