Comparison of Synthetic and Natural Caffeine on Hemodynamic Parameters in Young, Healthy Volunteers: A Randomized, Double Blind, Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Peripheral systolic blood pressure
研究概览
简要总结
The purpose of this study determine the difference in hemodynamic effects of synthetic and natural caffeine consumption in healthy individuals through blood pressure (central and peripheral) assessment. Participants will randomly be assigned to consume either one 8oz cup of coffee containing 400mg of caffeine (increased caffeine using concentrated coffee) or one 8oz cup of coffee-flavored drink with approximately 400mg synthetic caffeine from capsules dissolved in it.
详细描述
The purpose of this study is to assess the difference in effects of consuming synthetic versus natural caffeine on hemodynamic parameters in healthy subjects. This study will determine the difference in hemodynamic effects of synthetic and natural caffeine consumption in healthy individuals through blood pressure (central and peripheral) assessment. The participants in this study are healthy adults who will be introduced to a risk that may be more than they would encounter through their normal daily activities. This study seeks to add to the literature by evaluating the difference in impact of synthetic compared to natural caffeine on central blood pressure.
This protocol has the following aims:
- Investigators hypothesize there will be a (baseline adjusted [ΔBP]) difference in BP (peripheral and central) between the natural and synthetic caffeine arms in healthy volunteers post consumption.
- Investigators hypothesize there will be (baseline adjusted [ΔCO]) no difference in CO between the natural and synthetic caffeine arms in healthy volunteers post consumption.
- Investigators hypothesize there will be (baseline adjusted [ΔSVR]) no difference in SVR between the natural and synthetic caffeine arms in healthy volunteers hours post consumption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females
- •Active duty military service members
- •DoD beneficiaries
- •Participants must be willing to refrain from caffeine use 72 hours prior to study days one and five
排除标准
- •Cardiovascular risk factors: Heart rhythm other than normal sinus, history of atrial or ventricular arrhythmia, family history of premature sudden cardiac death before the age of 60, left ventricular hypertrophy, acute myocardial ischemia, atherosclerosis, hypertension, and palpitations. This will be determined through the questionnaire responses of the participant and thorough chart review.
- •Blood pressure at initial screening appointment or at baseline on study Day One greater than 130/80 and if 130-139/80-89, FRS risk greater than 10%.
- •Presence of any known medical condition, confirmed through participant interview up to the discretion of the research team. Examples of these are:
- •Hypertension
- •Thyroid disease
- •Type 1 or 2 Diabetes Mellitus
- •Recurrent headaches
- •Any psychiatric condition or neurological disorder including seizures
- •History of alcohol or drug abuse in the previous five years
- •Ever been diagnosed or told they have or had renal or hepatic dysfunction
- •Tobacco use
- •Concurrent use of any medication taken in an amount greater than twice a week, to include herbal products or supplements, not to include hormonal contraceptives. If less than or equal to two days per week, the investigator will determine if the subject is to be included or excluded based on the available literature for that medication.
- •Pregnant or lactating females will be excluded from participation with urine dipstick tests used to rule out pregnancy (pregnancy test performed before each treatment session, days one, five)
- •All non-English speaking/writing subjects and those that do not understand the study or consent process will be excluded from the study due to unavailability of medical qualified translator at all times during the study.
- •If the subject refuses to sign the informed consent document or HIPAA Authorization, they will be excluded as well.
- •Allergy to any substance in the study design.
- •Any other medical reason that at the discretion of the investigators would pose a risk to the health of the subject.
研究组 & 干预措施
Natural Caffeine
Subjects will be their own control and will have repeated measures after the consumption of a drink with 400mg of natural caffeine. Blood pressure measurements will be taken at baseline, then hourly for four hours.
干预措施: Natural Caffeine (Dietary Supplement)
Synthetic Caffeine
Subjects will be their own control and will have repeated measures after the consumption of a drink with 400mg of synthetic caffeine. Blood pressure measurements will be taken at baseline, then hourly for four hours.
干预措施: Synthetic Caffeine (Dietary Supplement)
结局指标
主要结局
Peripheral systolic blood pressure
时间窗: Four hours
Two peripheral systolic blood pressure measurements will be taken prior to the consumption of the assigned study drink. Repeated peripheral systolic blood pressure readings will occur twice at each time point hourly for a period of four hours. For each measurement, participant will be asked to rest for five minutes.
次要结局
- Cardiac output(Four hours)
- Change in peripheral diastolic blood pressure(Four hours)
研究者
Elizabeth Tesch
PGY-1 Pharmacy Resident
David Grant U.S. Air Force Medical Center