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

NCT03953469 | Unknown

• 1 other identifier: 2019-02-01
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Rate Fast; Blood Pressure

Keywords

passionflower; heart rate; blood pressure

Outcome Measures

Primary Outcomes (2)

• Change in blood pressure between baseline and 15 minutes

  Change in blood pressure between baseline and 15 minutes

  15 minutes

• Change in heart rate between baseline and 15 minutes

  Change in heart rate between baseline and 15 minutes

  15 minutes

Study Arms (2)

Placebo Group

NO INTERVENTION

(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 II

ACTIVE COMPARATOR

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.

Dietary Supplement: Passiflora incarnata

Interventions

Passiflora incarnata DIETARY_SUPPLEMENT

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

Also known as: Passionflower

Group II

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Bridgeport: lead

MeSH Terms

Conditions

Tachycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kimberly Sanders, ND

  University of Bridgeport

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kimberly Sanders, ND

CONTACT

2035764425; kimbersa@bridgeport.edu

Mark Mattie, MD, PhD

CONTACT

mmattie@bridgeport.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Assistant Professor of Clinical Sciences

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: May 16, 2019
• Study Start: August 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: August 1, 2021
• Last Updated: March 26, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share