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

Sponsor

University of Bridgeport (Other)

Overall Status

Unknown status

CT.gov ID

NCT03953469

Collaborator

(none)

250

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Rate Fast Blood Pressure	Dietary Supplement: Passiflora incarnata	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

250 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Aug 1, 2020

Anticipated Primary Completion Date :

May 1, 2021

Anticipated Study Completion Date :

Aug 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Placebo Group (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 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 One-time administration of 1/8 tsp solid extract Passiflora incarnata providing 900mg of Passiflora incarnata Other Names: Passionflower

Arm

Intervention/Treatment

No Intervention: Placebo Group

(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

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

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

Other Names:

Passionflower

Outcome Measures

Primary Outcome Measures

Change in blood pressure between baseline and 15 minutes [15 minutes]
Change in blood pressure between baseline and 15 minutes
Change in heart rate between baseline and 15 minutes [15 minutes]
Change in heart rate between baseline and 15 minutes

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Bridgeport

Investigators

Principal Investigator: Kimberly Sanders, ND, University of Bridgeport

Study Documents (Full-Text)

More Information

Publications

None provided.

Responsible Party:

Kimberly Sanders, Principal Investigator, Assistant Professor of Clinical Sciences, University of Bridgeport

ClinicalTrials.gov Identifier:

NCT03953469

Other Study ID Numbers:

2019-02-01

First Posted:

May 16, 2019

Last Update Posted:

Mar 26, 2020

Last Verified:

Mar 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Kimberly Sanders, Principal Investigator, Assistant Professor of Clinical Sciences, University of Bridgeport

passionflower

heart rate

blood pressure

Additional relevant MeSH terms:

Tachycardia

Study Results

No Results Posted as of Mar 26, 2020