Testing Potential Synergistic Effects of Albuterol and Caffeine on Metabolic Rate.
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- A change is being assessed for the combination of Albuterol and Caffeine on Metabolic rate.
研究概览
简要总结
The purpose of this study is to define a ratio of Caffeine and albuterol that gives a synergistic increase in metabolic rate.
详细描述
The study consists of 2 screening visits and 8 study visits. Screening visit 1: about 1 hour fasting from 9pm the prior night. Height and weight is measured, vital signs taken and questionnaires completed. Women will have a urine pregnancy test. Blood draw for chemistry panel and blood count.
Screening visit 2: about 1 hour, Medical history, physical examination, and electrocardiogram (a heart tracing).
Visit 1-8 about 4 hours each. 8 separate occasions, with about 7 days between each visit. ON each visit, blood pressure, pulse and temperature is recorded. A resting metabolic rate (RMR) is measured. After a baseline measurement of about 30 minutes of breathing is taken , a pill will be swallow and metabolism(measured by breathing with a clear plastic hood over the upper body to measure metabolic rate ( the oxygen inhaled and the carbon dioxide exhaled).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female between the ages of 18 to 50 years, inclusive.
- •Have a body mass index between 19 and 40 kg/M2 ( a number calculated from your height and weight), inclusive.
排除标准
- •Female who is pregnant or nursing.
- •Woman of childbearing potential and do not agree to use an effective method of contraception during the trial. Acceptable methods include abstinence, barrier methods, intrauterine devices, and hormonal methods of contraception.
- •A smoker or use nicotine.
- •Take regular medication other than birth control pills.
- •Use medications known to alter metabolic rate (some asthma medications).
研究组 & 干预措施
Albuterol 4mg
4mg of Albuterol or placebo is given in pill form
干预措施: 100mg of Caffeine (Drug)
Albuterol 2mg
2 mg of Albuterol is in a pill form or placebo
干预措施: 4mg of Albuterol (Drug)
Albuterol 2mg
2 mg of Albuterol is in a pill form or placebo
干预措施: 2mg of Albuterol (Drug)
Albuterol 2mg
2 mg of Albuterol is in a pill form or placebo
干预措施: 100mg of Caffeine (Drug)
Albuterol 2mg
2 mg of Albuterol is in a pill form or placebo
干预措施: 200mg of Caffeine (Drug)
Albuterol 2mg
2 mg of Albuterol is in a pill form or placebo
干预措施: Albuterol 2mg & Caffeine 100mg (Drug)
Albuterol 2mg
2 mg of Albuterol is in a pill form or placebo
干预措施: Albuterol 2mg and Caffeine 200mg (Drug)
Albuterol 2mg
2 mg of Albuterol is in a pill form or placebo
干预措施: Albuterol 4mg and Caffeine 100mg (Drug)
Albuterol 2mg
2 mg of Albuterol is in a pill form or placebo
干预措施: Albuterol 4mg and Caffeine 200mg (Drug)
Albuterol 4mg
4mg of Albuterol or placebo is given in pill form
干预措施: 2mg of Albuterol (Drug)
Albuterol 4mg
4mg of Albuterol or placebo is given in pill form
干预措施: 4mg of Albuterol (Drug)
Albuterol 4mg
4mg of Albuterol or placebo is given in pill form
干预措施: 200mg of Caffeine (Drug)
Albuterol 4mg
4mg of Albuterol or placebo is given in pill form
干预措施: Albuterol 2mg & Caffeine 100mg (Drug)
Albuterol 4mg
4mg of Albuterol or placebo is given in pill form
干预措施: Albuterol 2mg and Caffeine 200mg (Drug)
Albuterol 4mg
4mg of Albuterol or placebo is given in pill form
干预措施: Albuterol 4mg and Caffeine 100mg (Drug)
Albuterol 4mg
4mg of Albuterol or placebo is given in pill form
干预措施: Albuterol 4mg and Caffeine 200mg (Drug)
Caffeine 100mg
100mg of Caffeine or placebo is given in a pill form.
干预措施: 2mg of Albuterol (Drug)
Caffeine 100mg
100mg of Caffeine or placebo is given in a pill form.
干预措施: 4mg of Albuterol (Drug)
Caffeine 100mg
100mg of Caffeine or placebo is given in a pill form.
干预措施: 100mg of Caffeine (Drug)
Caffeine 100mg
100mg of Caffeine or placebo is given in a pill form.
干预措施: 200mg of Caffeine (Drug)
Caffeine 100mg
100mg of Caffeine or placebo is given in a pill form.
干预措施: Albuterol 2mg & Caffeine 100mg (Drug)
Caffeine 100mg
100mg of Caffeine or placebo is given in a pill form.
干预措施: Albuterol 2mg and Caffeine 200mg (Drug)
Caffeine 100mg
100mg of Caffeine or placebo is given in a pill form.
干预措施: Albuterol 4mg and Caffeine 100mg (Drug)
Caffeine 100mg
100mg of Caffeine or placebo is given in a pill form.
干预措施: Albuterol 4mg and Caffeine 200mg (Drug)
Caffeine 200mg
200mg of Caffeine or placebo is given in a pill form
干预措施: 2mg of Albuterol (Drug)
Caffeine 200mg
200mg of Caffeine or placebo is given in a pill form
干预措施: 4mg of Albuterol (Drug)
Caffeine 200mg
200mg of Caffeine or placebo is given in a pill form
干预措施: 100mg of Caffeine (Drug)
Caffeine 200mg
200mg of Caffeine or placebo is given in a pill form
干预措施: 200mg of Caffeine (Drug)
Caffeine 200mg
200mg of Caffeine or placebo is given in a pill form
干预措施: Albuterol 2mg & Caffeine 100mg (Drug)
Caffeine 200mg
200mg of Caffeine or placebo is given in a pill form
干预措施: Albuterol 2mg and Caffeine 200mg (Drug)
Caffeine 200mg
200mg of Caffeine or placebo is given in a pill form
干预措施: Albuterol 4mg and Caffeine 100mg (Drug)
Caffeine 200mg
200mg of Caffeine or placebo is given in a pill form
干预措施: Albuterol 4mg and Caffeine 200mg (Drug)
Albuterol 2mg & Caffeine 100mg
100mg of Caffeine in combination with Albuterol 2mg or placebo is given in a pill form.
干预措施: 4mg of Albuterol (Drug)
Albuterol 2mg & Caffeine 100mg
100mg of Caffeine in combination with Albuterol 2mg or placebo is given in a pill form.
干预措施: 100mg of Caffeine (Drug)
Albuterol 2mg & Caffeine 100mg
100mg of Caffeine in combination with Albuterol 2mg or placebo is given in a pill form.
干预措施: 200mg of Caffeine (Drug)
Albuterol 2mg & Caffeine 100mg
100mg of Caffeine in combination with Albuterol 2mg or placebo is given in a pill form.
干预措施: Albuterol 2mg & Caffeine 100mg (Drug)
Albuterol 2mg & Caffeine 100mg
100mg of Caffeine in combination with Albuterol 2mg or placebo is given in a pill form.
干预措施: Albuterol 2mg and Caffeine 200mg (Drug)
Albuterol 2mg & Caffeine 100mg
100mg of Caffeine in combination with Albuterol 2mg or placebo is given in a pill form.
干预措施: Albuterol 4mg and Caffeine 100mg (Drug)
Albuterol 2mg & Caffeine 100mg
100mg of Caffeine in combination with Albuterol 2mg or placebo is given in a pill form.
干预措施: Albuterol 4mg and Caffeine 200mg (Drug)
Albuterol 2mg and Caffeine 200mg
200mg of Caffeine in combination with Albuterol 2mg or placebo is given in a pill form.
干预措施: 2mg of Albuterol (Drug)
Albuterol 2mg and Caffeine 200mg
200mg of Caffeine in combination with Albuterol 2mg or placebo is given in a pill form.
干预措施: 4mg of Albuterol (Drug)
Albuterol 2mg and Caffeine 200mg
200mg of Caffeine in combination with Albuterol 2mg or placebo is given in a pill form.
干预措施: 100mg of Caffeine (Drug)
Albuterol 2mg and Caffeine 200mg
200mg of Caffeine in combination with Albuterol 2mg or placebo is given in a pill form.
干预措施: 200mg of Caffeine (Drug)
Albuterol 2mg and Caffeine 200mg
200mg of Caffeine in combination with Albuterol 2mg or placebo is given in a pill form.
干预措施: Albuterol 2mg & Caffeine 100mg (Drug)
Albuterol 2mg and Caffeine 200mg
200mg of Caffeine in combination with Albuterol 2mg or placebo is given in a pill form.
干预措施: Albuterol 2mg and Caffeine 200mg (Drug)
Albuterol 2mg and Caffeine 200mg
200mg of Caffeine in combination with Albuterol 2mg or placebo is given in a pill form.
干预措施: Albuterol 4mg and Caffeine 100mg (Drug)
Albuterol 2mg and Caffeine 200mg
200mg of Caffeine in combination with Albuterol 2mg or placebo is given in a pill form.
干预措施: Albuterol 4mg and Caffeine 200mg (Drug)
Albuterol 4mg and Caffeine 100mg
100mg of Caffeine in combination with Albuterol 4mg or placebo is given in a pill form.
干预措施: 2mg of Albuterol (Drug)
Albuterol 4mg and Caffeine 100mg
100mg of Caffeine in combination with Albuterol 4mg or placebo is given in a pill form.
干预措施: 4mg of Albuterol (Drug)
Albuterol 4mg and Caffeine 100mg
100mg of Caffeine in combination with Albuterol 4mg or placebo is given in a pill form.
干预措施: 100mg of Caffeine (Drug)
Albuterol 4mg and Caffeine 100mg
100mg of Caffeine in combination with Albuterol 4mg or placebo is given in a pill form.
干预措施: 200mg of Caffeine (Drug)
Albuterol 4mg and Caffeine 100mg
100mg of Caffeine in combination with Albuterol 4mg or placebo is given in a pill form.
干预措施: Albuterol 2mg & Caffeine 100mg (Drug)
Albuterol 4mg and Caffeine 100mg
100mg of Caffeine in combination with Albuterol 4mg or placebo is given in a pill form.
干预措施: Albuterol 2mg and Caffeine 200mg (Drug)
Albuterol 4mg and Caffeine 100mg
100mg of Caffeine in combination with Albuterol 4mg or placebo is given in a pill form.
干预措施: Albuterol 4mg and Caffeine 100mg (Drug)
Albuterol 4mg and Caffeine 100mg
100mg of Caffeine in combination with Albuterol 4mg or placebo is given in a pill form.
干预措施: Albuterol 4mg and Caffeine 200mg (Drug)
Albuterol 4mg and Caffeine 200mg
200mg of Caffeine in combination with Albuterol 4mg or placebo is given in a pill form.
干预措施: 2mg of Albuterol (Drug)
Albuterol 4mg and Caffeine 200mg
200mg of Caffeine in combination with Albuterol 4mg or placebo is given in a pill form.
干预措施: 4mg of Albuterol (Drug)
Albuterol 4mg and Caffeine 200mg
200mg of Caffeine in combination with Albuterol 4mg or placebo is given in a pill form.
干预措施: 100mg of Caffeine (Drug)
Albuterol 4mg and Caffeine 200mg
200mg of Caffeine in combination with Albuterol 4mg or placebo is given in a pill form.
干预措施: 200mg of Caffeine (Drug)
Albuterol 4mg and Caffeine 200mg
200mg of Caffeine in combination with Albuterol 4mg or placebo is given in a pill form.
干预措施: Albuterol 2mg & Caffeine 100mg (Drug)
Albuterol 4mg and Caffeine 200mg
200mg of Caffeine in combination with Albuterol 4mg or placebo is given in a pill form.
干预措施: Albuterol 2mg and Caffeine 200mg (Drug)
Albuterol 4mg and Caffeine 200mg
200mg of Caffeine in combination with Albuterol 4mg or placebo is given in a pill form.
干预措施: Albuterol 4mg and Caffeine 100mg (Drug)
Albuterol 4mg and Caffeine 200mg
200mg of Caffeine in combination with Albuterol 4mg or placebo is given in a pill form.
干预措施: Albuterol 4mg and Caffeine 200mg (Drug)
结局指标
主要结局
A change is being assessed for the combination of Albuterol and Caffeine on Metabolic rate.
时间窗: Participants will be followed at Baseline and the duration of the study, an expected average of 10 weeks.
The order of which 8 combinations will be determined randomly (like flipping a coin) and neither the participant nor the study personnel will know what is in the pills. The identity of the pills can be determined by breaking the code in the case of an emergency. 1. Albuterol 2mg; 2. Albuterol 4mg; 3. Caffeine 100mg; 4. Caffeine 200mg; 5. Albuterol 2mg and Caffeine 100mg; 6. Albuterol 2mg and Caffeine 200mg; 7. Albuterol 4mg and Caffeine 100mg; 8. Albuterol 4mg and Caffeine 200mg. The data will be analyzed by computing the metabolic rate. Metabolic rate is measured by breathing with a clear plastic hood over the upper body to measure the oxygen inhaled and the carbon dioxide exhaled.
次要结局
- Respiratory Quotient (RQ)(Participants will be followed at Baseline and the duration of the study, an expected average of 10 weeks.)
- Safety Assessments (lab, adverse events, physical exams and electrocardiograms)(Participants will be followed at Baseline and the duration of the study, an expected average of 10 weeks.)
- Pulse rate(Participants will be followed at Baseline and the duration of the study, an expected average of 10 weeks.)
- Temperature(Participants will be followed at Baseline and the duration of the study, an expected average of 10 weeks.)
- Blood Pressure(Baseline to 8 time points of dose)
研究者
Frank Greenway
Principal Investigator
Pennington Biomedical Research Center