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

Not Applicable

• Conditions: Blood Pressure; Heart Rate Fast
• Interventions: Dietary Supplement: Passiflora incarnata

• Registration Number: NCT03953469
• Lead Sponsor: University of Bridgeport

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-09
• Study First Submitted QC: 2019-05-15
• Study First Posted: 2019-05-16
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-24
• Last Update Posted: 2020-03-26
• Study Start: 2020-08
• Primary Completion: 2021-05
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

all University of Bridgeport students are invited to participate

Exclusion Criteria

1. Those taking hypertensive medication
2. Those taking anti-anxiety medication, including MAOI medication
3. Those taking blood-thinning medication
4. Those who are pregnant
5. Those who could be pregnant
6. Those who will have surgery 2 weeks before the research date
7. Those who are scheduled to have surgery 2 weeks after the research date
8. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II	Passiflora incarnata	1. 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. 2. 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. 3. blood pressure readings and one heart rate will be taken 15 minutes after the baseline reading.

Primary Outcome Measures

Name	Time	Method
Change in heart rate between baseline and 15 minutes	15 minutes	Change in heart rate between baseline and 15 minutes
Change in blood pressure between baseline and 15 minutes	15 minutes	Change in blood pressure between baseline and 15 minutes