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

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03953469
• Other study ID #: 2019-02-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2020
• Est. completion date: August 2021

Study information

• Verified date: March 2020
• Source: University of Bridgeport
• Contact: Kimberly Sanders, ND
• Phone: 2035764425
• Email: kimbersa[@]bridgeport.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: August 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Blood Pressure
• Heart Rate Fast
• Tachycardia

Intervention

Dietary Supplement:
• Passiflora incarnata
One-time administration of 1/8 tsp solid extract Passiflora incarnata providing 900mg of Passiflora incarnata

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Bridgeport

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in blood pressure between baseline and 15 minutes	Change in blood pressure between baseline and 15 minutes	15 minutes
Primary	Change in heart rate between baseline and 15 minutes	Change in heart rate between baseline and 15 minutes	15 minutes