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

Primary Purpose

Heart Rate Fast, Blood Pressure

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Passiflora incarnata
Sponsored by
University of Bridgeport
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Rate Fast focused on measuring passionflower, heart rate, blood pressure

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Active Comparator

    Arm Label

    Placebo Group

    Group II

    Arm Description

    (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.

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    May 9, 2019
    Last Updated
    March 24, 2020
    Sponsor
    University of Bridgeport
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03953469
    Brief Title
    Short-term Effects of Passiflora and Meditation on Blood Pressure and Heart Rate
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2020 (Anticipated)
    Primary Completion Date
    May 2021 (Anticipated)
    Study Completion Date
    August 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Bridgeport

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Rate Fast, Blood Pressure
    Keywords
    passionflower, heart rate, blood pressure

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes 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.
    Allocation
    Randomized
    Enrollment
    250 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo Group
    Arm Type
    No Intervention
    Arm Description
    (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.
    Arm Title
    Group II
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Passiflora incarnata
    Other Intervention Name(s)
    Passionflower
    Intervention Description
    One-time administration of 1/8 tsp solid extract Passiflora incarnata providing 900mg of Passiflora incarnata
    Primary Outcome Measure Information:
    Title
    Change in blood pressure between baseline and 15 minutes
    Description
    Change in blood pressure between baseline and 15 minutes
    Time Frame
    15 minutes
    Title
    Change in heart rate between baseline and 15 minutes
    Description
    Change in heart rate between baseline and 15 minutes
    Time Frame
    15 minutes

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kimberly Sanders, ND
    Phone
    2035764425
    Email
    kimbersa@bridgeport.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mark Mattie, MD, PhD
    Email
    mmattie@bridgeport.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kimberly Sanders, ND
    Organizational Affiliation
    University of Bridgeport
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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