Investigating the Short-term Effects of Passiflora Incarnate and Mobile Audio-guided Meditation on Blood Pressure and Heart Rate in Naturopathic Medical Students
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 主要终点
- Change in heart rate between baseline and 15 minutes
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •all University of Bridgeport students are invited to participate
排除标准
- •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.
研究组 & 干预措施
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 II
- 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.
干预措施: Passiflora incarnata (Dietary Supplement)
结局指标
主要结局
Change in heart rate between baseline and 15 minutes
时间窗: 15 minutes
Change in heart rate between baseline and 15 minutes
Change in blood pressure between baseline and 15 minutes
时间窗: 15 minutes
Change in blood pressure between baseline and 15 minutes
次要结局
未报告次要终点
研究者
Kimberly Sanders
Principal Investigator, Assistant Professor of Clinical Sciences
University of Bridgeport