Testing Potential Synergistic Effects of Albuterol and Caffeine on Metabolic Rate

Healthy Volunteers Clinical Trial

— CALM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02135965
• Other study ID #: PBRC 28026
• Status: Completed
• Phase: Phase 0
• First received: May 7, 2014
• Last updated: December 17, 2015
• Start date: April 2009
• Est. completion date: August 2011

Study information

• Verified date: December 2015
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• 2mg of Albuterol
2mg of Albuterol on metabolic rate
• 4mg of Albuterol
4mg of Albuterol on metabolic rate
• 100mg of Caffeine
100mg of caffeine on metabolic rate
• 200mg of Caffeine
200mg of Caffeine on metabolic rate
• Albuterol 2mg & Caffeine 100mg
Albuterol 2mg and 100mg of Caffeine
• Albuterol 2mg and Caffeine 200mg
Albuterol 2mg and Caffeine 200mg on metabolic rate
• Albuterol 4mg and Caffeine 100mg
Albuterol 4mg and Caffeine 100mg on metabolic rate
• Albuterol 4mg and Caffeine 200mg
Albuterol 4mg and Caffeine 200mg on metabolic rate

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A change is being assessed for the combination of Albuterol and Caffeine on Metabolic rate.	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.	No
Secondary	Respiratory Quotient (RQ)	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.	Yes
Secondary	Pulse rate	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.	Yes
Secondary	Blood Pressure	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	Yes
Secondary	Temperature	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.	Yes
Secondary	Safety Assessments (lab, adverse events, physical exams and electrocardiograms)	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.	Yes