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

NCT ID: NCT03953469

Last Updated: 2020-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-31

Study Completion Date

2021-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Rate Fast Blood Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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.

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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 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.
3. blood pressure readings and one heart rate will be taken 15 minutes after the baseline reading.

Group Type ACTIVE_COMPARATOR

Passiflora incarnata

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Passiflora incarnata

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Passionflower

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Bridgeport

OTHER

Sponsor Role lead

Responsible Party

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Kimberly Sanders

Principal Investigator, Assistant Professor of Clinical Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kimberly Sanders, ND

Role: PRINCIPAL_INVESTIGATOR

University of Bridgeport

Central Contacts

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Kimberly Sanders, ND

Role: CONTACT

2035764425

Mark Mattie, MD, PhD

Role: CONTACT

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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2019-02-01

Identifier Type: -

Identifier Source: org_study_id

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