Short-term Effects of Passiflora and Meditation on Blood Pressure and Heart Rate

Study Overview
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Brief Summary
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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.

Official Title
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Investigating the Short-term Effects of Passiflora Incarnate and Mobile Audio-guided Meditation on Blood Pressure and Heart Rate in Naturopathic Medical Students

Conditions
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Heart Rate Fast, Blood Pressure

Intervention / Treatment
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* Dietary Supplement: Passiflora incarnata


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all University of Bridgeport students are invited to participate Exclusion Criteria: Those taking hypertensive medication Those taking anti-anxiety medication, including MAOI medication Those taking blood-thinning medication Those who are pregnant Those who could be pregnant Those who will have surgery 2 weeks before the research date Those who are scheduled to have surgery 2 weeks after the research date Those who have consumed caffeine, food/tyramine containing foods, stimulant medication, cold medicine, decongestant medicine, antihistamine medicine, cough suppressants, alcoholic beverages, or stimulant energy drinks within 2 hours before the study period.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Placebo Group<br>(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. | |
| Active Comparator: Group II<br>Baseline blood pressure readings and one heart rate reading taken after at least 5 minutes of rest time without talking, eating food, or caffeine consumption. 15 minutes after examination - will be given 1/8 tsp (900mg) of Passiflora incarnata solid extract by Wise Woman Herbals mixed with 1/8 tsp of blackstrap molasses to mask the taste. blood pressure readings and one heart rate will be taken 15 minutes after the baseline reading. | Dietary Supplement: Passiflora incarnata<br>* One-time administration of 1/8 tsp solid extract Passiflora incarnata providing 900mg of Passiflora incarnata<br>* Other names: Passionflower;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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passionflower, heart rate, blood pressure