Short-term Effects of Passiflora and Meditation on Blood Pressure and Heart Rate
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ClinicalTrials.gov Identifier: NCT03953469 |
Recruitment Status : Unknown
Verified March 2020 by Kimberly Sanders, University of Bridgeport.
Recruitment status was: Not yet recruiting
First Posted : May 16, 2019
Last Update Posted : March 26, 2020
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Condition or disease | Intervention/treatment | Phase |
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Heart Rate Fast Blood Pressure | Dietary Supplement: Passiflora incarnata | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated 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 |
Estimated Study Start Date : | August 2020 |
Estimated Primary Completion Date : | May 2021 |
Estimated Study Completion Date : | August 2021 |
Arm | Intervention/treatment |
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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. |
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Active Comparator: Group II
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Dietary Supplement: Passiflora incarnata
One-time administration of 1/8 tsp solid extract Passiflora incarnata providing 900mg of Passiflora incarnata
Other Name: Passionflower |
- Change in blood pressure between baseline and 15 minutes [ Time Frame: 15 minutes ]Change in blood pressure between baseline and 15 minutes
- Change in heart rate between baseline and 15 minutes [ Time Frame: 15 minutes ]Change in heart rate between baseline and 15 minutes
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Ages Eligible for Study: | Child, Adult, Older Adult |
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.
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
Contact: Kimberly Sanders, ND | 2035764425 | kimbersa@bridgeport.edu | |
Contact: Mark Mattie, MD, PhD | mmattie@bridgeport.edu |
Principal Investigator: | Kimberly Sanders, ND | University of Bridgeport |
Documents provided by Kimberly Sanders, University of Bridgeport:
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 Key Record Dates |
Last Update Posted: | March 26, 2020 |
Last Verified: | March 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
passionflower heart rate blood pressure |
Tachycardia Arrhythmias, Cardiac Heart Diseases |
Cardiovascular Diseases Cardiac Conduction System Disease Pathologic Processes |