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Testing Potential Synergistic Effects of Albuterol and Caffeine on Metabolic Rate

Information source: Pennington Biomedical Research Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Volunteers

Intervention: 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 (Drug)

Phase: Phase 0

Status: Completed

Sponsored by: Pennington Biomedical Research Center

Summary

The purpose of this study is to define a ratio of Caffeine and albuterol that gives a synergistic increase in metabolic rate.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Primary outcome: A change is being assessed for the combination of Albuterol and Caffeine on Metabolic rate.

Secondary outcome:

Respiratory Quotient (RQ)

Pulse rate

Blood Pressure

Temperature

Safety Assessments (lab, adverse events, physical exams and electrocardiograms)

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

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.

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).

Locations and Contacts

Pennington Biomedical Research Center, Baton Rouge, Louisiana 70808, United States
Additional Information

Starting date: April 2009
Last updated: May 8, 2014

Page last updated: August 23, 2015

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