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

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ClinicalTrials.gov Identifier: NCT03953469
Recruitment Status : Not yet recruiting
First Posted : May 16, 2019
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
Kimberly Sanders, 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, along with a 10 minute audio-guided mobile meditation on naturopathic medical students after taking a classroom examination. Our hypothesis is that blood pressure levels and heart rates will decrease significantly in response to both Passiflora incarnata and the meditation.

Condition or disease Intervention/treatment Phase
Heart Rate Fast Blood Pressure Dietary Supplement: Passiflora incarnata Behavioral: Audio-Guided Meditation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: There are three arms. One arm involves having no intervention done, which both the primary investigator and the participant will realize since they will not be consuming anything or listening to a meditation. The second arm involves taking a placebo and doing the meditation, which neither the primary investigator nor the participant will know. The third arm involves taking the Passionflower and doing the meditation, which neither the primary investigator nor the participant will know.
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
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Passiflora

Arm Intervention/treatment
No Intervention: Group I
  1. Baseline blood pressure readings and one heart rate reading taken after at least 5 minutes of rest time without talking, eating, or caffeine consumption.
  2. This group will not be given any intervention. Subjects will sit quietly for 15 minutes and can read a book, surf the internet, etc. Subjects may not consume caffeine, eat food, or listen to any meditation during this time.
  3. blood pressure readings and one heart rate will be taken 15 minutes after the baseline reading.
Active Comparator: Group II
  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 classroom examination - will be given 1/4 tsp of blackstrap molasses placebo and a 10 minute audio-guided mobile meditation session via the Headspace App. Subjects may not consume caffeine or eat food during this time.
  3. blood pressure readings and one heart rate will be taken 15 minutes after the baseline reading.
Behavioral: Audio-Guided Meditation
10 minute audio-guided meditation via HeadSpace mobile application

Experimental: Group III
  1. Baseline blood pressure readings and one heart rate reading taken after at least 5 minutes of rest time without talking, eating, 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 and a 10 minute audio-guided mobile meditation session via the Headspace App. Subjects may not consume caffeine or eat food during this time.
  3. 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 Name: Passionflower




Primary Outcome Measures :
  1. Change in blood pressure between baseline and 15 minutes [ Time Frame: 15 minutes ]
  2. Change in heart rate between baseline and 15 minutes [ Time Frame: 15 minutes ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: all naturopathic medical students are invited to participate

(1) Participants must have a smartphone with access to the Headspace application and headphones to listen to the session

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 do not have a smartphone or access to Headspace application
  9. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03953469


Contacts
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Contact: Kimberly Sanders, ND 2035764425 kimbersa@bridgeport.edu
Contact: Mark Mattie, MD, PhD mmattie@bridgeport.edu

Sponsors and Collaborators
University of Bridgeport
Investigators
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Principal Investigator: Kimberly Sanders, ND University of Bridgeport
  Study Documents (Full-Text)

Documents provided by Kimberly Sanders, University of Bridgeport:
Study Protocol  [PDF] March 28, 2019
Informed Consent Form  [PDF] March 28, 2019


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Responsible Party: Kimberly Sanders, Principal Investigator, Assistant Professor of Clinical Sciences, University of Bridgeport
ClinicalTrials.gov Identifier: NCT03953469     History of Changes
Other Study ID Numbers: 2019-02-01
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kimberly Sanders, University of Bridgeport:
passionflower
meditation
heart rate
blood pressure
Additional relevant MeSH terms:
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Tachycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes