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Testing Potential Synergistic Effects of Albuterol and Caffeine on Metabolic Rate (CALM)

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ClinicalTrials.gov Identifier: NCT02135965
Recruitment Status : Completed
First Posted : May 12, 2014
Last Update Posted : December 18, 2015
Sponsor:
Information provided by (Responsible Party):
Frank Greenway, Pennington Biomedical Research Center

Tracking Information
First Submitted Date  ICMJE May 7, 2014
First Posted Date  ICMJE May 12, 2014
Last Update Posted Date December 18, 2015
Study Start Date  ICMJE April 2009
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2014)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Testing Potential Synergistic Effects of Albuterol and Caffeine on Metabolic Rate
Official Title  ICMJE Testing Potential Synergistic Effects of Albuterol and Caffeine on Metabolic Rate.
Brief Summary The purpose of this study is to define a ratio of Caffeine and albuterol that gives a synergistic increase in metabolic rate.
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  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: 2mg of Albuterol
    2mg of Albuterol on metabolic rate
    Other Name: Albuterol
  • Drug: 4mg of Albuterol
    4mg of Albuterol on metabolic rate
    Other Name: Albuterol
  • Drug: 100mg of Caffeine
    100mg of caffeine on metabolic rate
    Other Name: Caffeine
  • Drug: 200mg of Caffeine
    200mg of Caffeine on metabolic rate
    Other Name: Caffeine
  • Drug: Albuterol 2mg & Caffeine 100mg
    Albuterol 2mg and 100mg of Caffeine
    Other Names:
    • Caffeine
    • Albuterol
  • Drug: Albuterol 2mg and Caffeine 200mg
    Albuterol 2mg and Caffeine 200mg on metabolic rate
    Other Names:
    • Albuterol
    • Caffeine
  • Drug: Albuterol 4mg and Caffeine 100mg
    Albuterol 4mg and Caffeine 100mg on metabolic rate
    Other Names:
    • Albuterol
    • Caffeine
  • Drug: Albuterol 4mg and Caffeine 200mg
    Albuterol 4mg and Caffeine 200mg on metabolic rate
    Other Names:
    • Albuterol
    • Caffeine
Study Arms  ICMJE
  • Experimental: Albuterol 2mg
    2 mg of Albuterol is in a pill form or placebo
    Interventions:
    • Drug: 2mg of Albuterol
    • Drug: 4mg of Albuterol
    • Drug: 100mg of Caffeine
    • Drug: 200mg of Caffeine
    • Drug: Albuterol 2mg & Caffeine 100mg
    • Drug: Albuterol 2mg and Caffeine 200mg
    • Drug: Albuterol 4mg and Caffeine 100mg
    • Drug: Albuterol 4mg and Caffeine 200mg
  • Experimental: Albuterol 4mg
    4mg of Albuterol or placebo is given in pill form
    Interventions:
    • Drug: 2mg of Albuterol
    • Drug: 4mg of Albuterol
    • Drug: 100mg of Caffeine
    • Drug: 200mg of Caffeine
    • Drug: Albuterol 2mg & Caffeine 100mg
    • Drug: Albuterol 2mg and Caffeine 200mg
    • Drug: Albuterol 4mg and Caffeine 100mg
    • Drug: Albuterol 4mg and Caffeine 200mg
  • Experimental: Caffeine 100mg
    100mg of Caffeine or placebo is given in a pill form.
    Interventions:
    • Drug: 2mg of Albuterol
    • Drug: 4mg of Albuterol
    • Drug: 100mg of Caffeine
    • Drug: 200mg of Caffeine
    • Drug: Albuterol 2mg & Caffeine 100mg
    • Drug: Albuterol 2mg and Caffeine 200mg
    • Drug: Albuterol 4mg and Caffeine 100mg
    • Drug: Albuterol 4mg and Caffeine 200mg
  • Experimental: Caffeine 200mg
    200mg of Caffeine or placebo is given in a pill form
    Interventions:
    • Drug: 2mg of Albuterol
    • Drug: 4mg of Albuterol
    • Drug: 100mg of Caffeine
    • Drug: 200mg of Caffeine
    • Drug: Albuterol 2mg & Caffeine 100mg
    • Drug: Albuterol 2mg and Caffeine 200mg
    • Drug: Albuterol 4mg and Caffeine 100mg
    • Drug: Albuterol 4mg and Caffeine 200mg
  • Experimental: Albuterol 2mg & Caffeine 100mg
    100mg of Caffeine in combination with Albuterol 2mg or placebo is given in a pill form.
    Interventions:
    • Drug: 4mg of Albuterol
    • Drug: 100mg of Caffeine
    • Drug: 200mg of Caffeine
    • Drug: Albuterol 2mg & Caffeine 100mg
    • Drug: Albuterol 2mg and Caffeine 200mg
    • Drug: Albuterol 4mg and Caffeine 100mg
    • Drug: Albuterol 4mg and Caffeine 200mg
  • Experimental: Albuterol 2mg and Caffeine 200mg
    200mg of Caffeine in combination with Albuterol 2mg or placebo is given in a pill form.
    Interventions:
    • Drug: 2mg of Albuterol
    • Drug: 4mg of Albuterol
    • Drug: 100mg of Caffeine
    • Drug: 200mg of Caffeine
    • Drug: Albuterol 2mg & Caffeine 100mg
    • Drug: Albuterol 2mg and Caffeine 200mg
    • Drug: Albuterol 4mg and Caffeine 100mg
    • Drug: Albuterol 4mg and Caffeine 200mg
  • Experimental: Albuterol 4mg and Caffeine 100mg
    100mg of Caffeine in combination with Albuterol 4mg or placebo is given in a pill form.
    Interventions:
    • Drug: 2mg of Albuterol
    • Drug: 4mg of Albuterol
    • Drug: 100mg of Caffeine
    • Drug: 200mg of Caffeine
    • Drug: Albuterol 2mg & Caffeine 100mg
    • Drug: Albuterol 2mg and Caffeine 200mg
    • Drug: Albuterol 4mg and Caffeine 100mg
    • Drug: Albuterol 4mg and Caffeine 200mg
  • Experimental: Albuterol 4mg and Caffeine 200mg
    200mg of Caffeine in combination with Albuterol 4mg or placebo is given in a pill form.
    Interventions:
    • Drug: 2mg of Albuterol
    • Drug: 4mg of Albuterol
    • Drug: 100mg of Caffeine
    • Drug: 200mg of Caffeine
    • Drug: Albuterol 2mg & Caffeine 100mg
    • Drug: Albuterol 2mg and Caffeine 200mg
    • Drug: Albuterol 4mg and Caffeine 100mg
    • Drug: Albuterol 4mg and Caffeine 200mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 8, 2014)
8
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02135965
Other Study ID Numbers  ICMJE PBRC 28026
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Frank Greenway, Pennington Biomedical Research Center
Study Sponsor  ICMJE Pennington Biomedical Research Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Pennington Biomedical Research Center
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP