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Completed

NCT Number: NCT02135965

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

2mg of Albuterol

Drug

2mg of Albuterol on metabolic rate

Other names: Albuterol

4mg of Albuterol

Drug

4mg of Albuterol on metabolic rate

Other names: Albuterol

100mg of Caffeine

Drug

100mg of caffeine on metabolic rate

Other names: Caffeine

200mg of Caffeine

Drug

200mg of Caffeine on metabolic rate

Other names: Caffeine

Albuterol 2mg & Caffeine 100mg

Drug

Albuterol 2mg and 100mg of Caffeine

Other names: Caffeine, Albuterol

Albuterol 2mg and Caffeine 200mg

Drug

Albuterol 2mg and Caffeine 200mg on metabolic rate

Other names: Albuterol, Caffeine

Albuterol 4mg and Caffeine 100mg

Drug

Albuterol 4mg and Caffeine 100mg on metabolic rate

Other names: Albuterol, Caffeine

Albuterol 4mg and Caffeine 200mg

Drug

Albuterol 4mg and Caffeine 200mg on metabolic rate

Other names: Albuterol, Caffeine

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Official study title

Testing Potential Synergistic Effects of Albuterol and Caffeine on Metabolic Rate.

Acronym: CALM

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
May 12, 2014
Registry last updated
Dec 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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