Clinical trial NCT02135965: Testing Potential Synergistic Effects of Albuterol and Caffeine on Metabolic Rate
Official title: Testing Potential Synergistic Effects of Albuterol and Caffeine on Metabolic Rate.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2014-05-12
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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).

Eligibility criteria: 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).

Primary outcomes:
measure: A change is being assessed for the combination of Albuterol and Caffeine on Metabolic rate.
timeFrame: Participants will be followed at Baseline and the duration of the study, an expected average of 10 weeks.
Secondary outcomes:
measure: Respiratory Quotient (RQ)
timeFrame: Participants will be followed at Baseline and the duration of the study, an expected average of 10 weeks.
measure: Pulse rate
timeFrame: Participants will be followed at Baseline and the duration of the study, an expected average of 10 weeks.
measure: Blood Pressure
timeFrame: Baseline to 8 time points of dose
measure: Temperature
timeFrame: Participants will be followed at Baseline and the duration of the study, an expected average of 10 weeks.
measure: Safety Assessments (lab, adverse events, physical exams and electrocardiograms)
timeFrame: Participants will be followed at Baseline and the duration of the study, an expected average of 10 weeks.
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
References: