Testing Potential Synergistic Effects of Albuterol and Caffeine on Metabolic Rate (CALM)
December 17, 2015 updated by: Frank Greenway, Pennington Biomedical Research Center
Testing Potential Synergistic Effects of Albuterol and Caffeine on Metabolic Rate.
The purpose of this study is to define a ratio of Caffeine and albuterol that gives a synergistic increase in metabolic rate.
Study Overview
Status
Completed
Conditions
Detailed Description
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).
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Louisiana
-
Baton Rouge, Louisiana, United States, 70808
- Pennington Biomedical Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Albuterol 2mg
2 mg of Albuterol is in a pill form or placebo
|
2mg of Albuterol on metabolic rate
Other Names:
4mg of Albuterol on metabolic rate
Other Names:
100mg of caffeine on metabolic rate
Other Names:
200mg of Caffeine on metabolic rate
Other Names:
Albuterol 2mg and 100mg of Caffeine
Other Names:
Albuterol 2mg and Caffeine 200mg on metabolic rate
Other Names:
Albuterol 4mg and Caffeine 100mg on metabolic rate
Other Names:
Albuterol 4mg and Caffeine 200mg on metabolic rate
Other Names:
|
|
Experimental: Albuterol 4mg
4mg of Albuterol or placebo is given in pill form
|
2mg of Albuterol on metabolic rate
Other Names:
4mg of Albuterol on metabolic rate
Other Names:
100mg of caffeine on metabolic rate
Other Names:
200mg of Caffeine on metabolic rate
Other Names:
Albuterol 2mg and 100mg of Caffeine
Other Names:
Albuterol 2mg and Caffeine 200mg on metabolic rate
Other Names:
Albuterol 4mg and Caffeine 100mg on metabolic rate
Other Names:
Albuterol 4mg and Caffeine 200mg on metabolic rate
Other Names:
|
|
Experimental: Caffeine 100mg
100mg of Caffeine or placebo is given in a pill form.
|
2mg of Albuterol on metabolic rate
Other Names:
4mg of Albuterol on metabolic rate
Other Names:
100mg of caffeine on metabolic rate
Other Names:
200mg of Caffeine on metabolic rate
Other Names:
Albuterol 2mg and 100mg of Caffeine
Other Names:
Albuterol 2mg and Caffeine 200mg on metabolic rate
Other Names:
Albuterol 4mg and Caffeine 100mg on metabolic rate
Other Names:
Albuterol 4mg and Caffeine 200mg on metabolic rate
Other Names:
|
|
Experimental: Caffeine 200mg
200mg of Caffeine or placebo is given in a pill form
|
2mg of Albuterol on metabolic rate
Other Names:
4mg of Albuterol on metabolic rate
Other Names:
100mg of caffeine on metabolic rate
Other Names:
200mg of Caffeine on metabolic rate
Other Names:
Albuterol 2mg and 100mg of Caffeine
Other Names:
Albuterol 2mg and Caffeine 200mg on metabolic rate
Other Names:
Albuterol 4mg and Caffeine 100mg on metabolic rate
Other Names:
Albuterol 4mg and Caffeine 200mg on metabolic rate
Other Names:
|
|
Experimental: Albuterol 2mg & Caffeine 100mg
100mg of Caffeine in combination with Albuterol 2mg or placebo is given in a pill form.
|
4mg of Albuterol on metabolic rate
Other Names:
100mg of caffeine on metabolic rate
Other Names:
200mg of Caffeine on metabolic rate
Other Names:
Albuterol 2mg and 100mg of Caffeine
Other Names:
Albuterol 2mg and Caffeine 200mg on metabolic rate
Other Names:
Albuterol 4mg and Caffeine 100mg on metabolic rate
Other Names:
Albuterol 4mg and Caffeine 200mg on metabolic rate
Other Names:
|
|
Experimental: Albuterol 2mg and Caffeine 200mg
200mg of Caffeine in combination with Albuterol 2mg or placebo is given in a pill form.
|
2mg of Albuterol on metabolic rate
Other Names:
4mg of Albuterol on metabolic rate
Other Names:
100mg of caffeine on metabolic rate
Other Names:
200mg of Caffeine on metabolic rate
Other Names:
Albuterol 2mg and 100mg of Caffeine
Other Names:
Albuterol 2mg and Caffeine 200mg on metabolic rate
Other Names:
Albuterol 4mg and Caffeine 100mg on metabolic rate
Other Names:
Albuterol 4mg and Caffeine 200mg on metabolic rate
Other Names:
|
|
Experimental: Albuterol 4mg and Caffeine 100mg
100mg of Caffeine in combination with Albuterol 4mg or placebo is given in a pill form.
|
2mg of Albuterol on metabolic rate
Other Names:
4mg of Albuterol on metabolic rate
Other Names:
100mg of caffeine on metabolic rate
Other Names:
200mg of Caffeine on metabolic rate
Other Names:
Albuterol 2mg and 100mg of Caffeine
Other Names:
Albuterol 2mg and Caffeine 200mg on metabolic rate
Other Names:
Albuterol 4mg and Caffeine 100mg on metabolic rate
Other Names:
Albuterol 4mg and Caffeine 200mg on metabolic rate
Other Names:
|
|
Experimental: Albuterol 4mg and Caffeine 200mg
200mg of Caffeine in combination with Albuterol 4mg or placebo is given in a pill form.
|
2mg of Albuterol on metabolic rate
Other Names:
4mg of Albuterol on metabolic rate
Other Names:
100mg of caffeine on metabolic rate
Other Names:
200mg of Caffeine on metabolic rate
Other Names:
Albuterol 2mg and 100mg of Caffeine
Other Names:
Albuterol 2mg and Caffeine 200mg on metabolic rate
Other Names:
Albuterol 4mg and Caffeine 100mg on metabolic rate
Other Names:
Albuterol 4mg and Caffeine 200mg on metabolic rate
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
A change is being assessed for the combination of Albuterol and Caffeine on Metabolic rate.
Time Frame: 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.
|
Participants will be followed at Baseline and the duration of the study, an expected average of 10 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Respiratory Quotient (RQ)
Time Frame: Participants will be followed at Baseline and the duration of the study, an expected average of 10 weeks.
|
The respiratory quotient (RQ) is calculated from a ratio indicating the relation of the volume of carbon dioxide given off in respiration to that of the oxygen consumed.
|
Participants will be followed at Baseline and the duration of the study, an expected average of 10 weeks.
|
|
Pulse rate
Time Frame: Participants will be followed at Baseline and the duration of the study, an expected average of 10 weeks.
|
Pulse is the rate at which the heart beats.
The pulse is usually called heart rate, which is the number of times the heart beats each minute.
|
Participants will be followed at Baseline and the duration of the study, an expected average of 10 weeks.
|
|
Blood Pressure
Time Frame: Baseline to 8 time points of dose
|
When the heart beats, it contracts and pushes blood through the arteries to the rest of your body.
This force creates pressure on the arteries.
This is called systolic blood pressure or the top number.
A systolic blood pressure or the bottom number indicates the pressure in the arteries when the heart rests between beats.
|
Baseline to 8 time points of dose
|
|
Temperature
Time Frame: Participants will be followed at Baseline and the duration of the study, an expected average of 10 weeks.
|
An oral temperature is when the thermometer is placed in the mouth to measure the body heat.
|
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)
Time Frame: Participants will be followed at Baseline and the duration of the study, an expected average of 10 weeks.
|
Labs, adverse events, physical exams and electrocardiograms (ECG or EKG) are assessed to make sure nothing is out of normal range.
|
Participants will be followed at Baseline and the duration of the study, an expected average of 10 weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
May 7, 2014
First Submitted That Met QC Criteria
May 8, 2014
First Posted (Estimate)
May 12, 2014
Study Record Updates
Last Update Posted (Estimate)
December 18, 2015
Last Update Submitted That Met QC Criteria
December 17, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Purinergic Antagonists
- Purinergic Agents
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Reproductive Control Agents
- Phosphodiesterase Inhibitors
- Purinergic P1 Receptor Antagonists
- Central Nervous System Stimulants
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Tocolytic Agents
- Albuterol
- Caffeine
Other Study ID Numbers
- PBRC 28026
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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