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Testing Potential Synergistic Effects of Albuterol and Caffeine on Metabolic Rate

NCT ID: NCT02135965

Last Updated: 2015-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2011-08-31

Brief Summary

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

Detailed Description

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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).

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Albuterol 2mg

2 mg of Albuterol is in a pill form or placebo

Group Type EXPERIMENTAL

2mg of Albuterol

Intervention Type DRUG

2mg of Albuterol on metabolic rate

4mg of Albuterol

Intervention Type DRUG

4mg of Albuterol on metabolic rate

100mg of Caffeine

Intervention Type DRUG

100mg of caffeine on metabolic rate

200mg of Caffeine

Intervention Type DRUG

200mg of Caffeine on metabolic rate

Albuterol 2mg & Caffeine 100mg

Intervention Type DRUG

Albuterol 2mg and 100mg of Caffeine

Albuterol 2mg and Caffeine 200mg

Intervention Type DRUG

Albuterol 2mg and Caffeine 200mg on metabolic rate

Albuterol 4mg and Caffeine 100mg

Intervention Type DRUG

Albuterol 4mg and Caffeine 100mg on metabolic rate

Albuterol 4mg and Caffeine 200mg

Intervention Type DRUG

Albuterol 4mg and Caffeine 200mg on metabolic rate

Albuterol 4mg

4mg of Albuterol or placebo is given in pill form

Group Type EXPERIMENTAL

2mg of Albuterol

Intervention Type DRUG

2mg of Albuterol on metabolic rate

4mg of Albuterol

Intervention Type DRUG

4mg of Albuterol on metabolic rate

100mg of Caffeine

Intervention Type DRUG

100mg of caffeine on metabolic rate

200mg of Caffeine

Intervention Type DRUG

200mg of Caffeine on metabolic rate

Albuterol 2mg & Caffeine 100mg

Intervention Type DRUG

Albuterol 2mg and 100mg of Caffeine

Albuterol 2mg and Caffeine 200mg

Intervention Type DRUG

Albuterol 2mg and Caffeine 200mg on metabolic rate

Albuterol 4mg and Caffeine 100mg

Intervention Type DRUG

Albuterol 4mg and Caffeine 100mg on metabolic rate

Albuterol 4mg and Caffeine 200mg

Intervention Type DRUG

Albuterol 4mg and Caffeine 200mg on metabolic rate

Caffeine 100mg

100mg of Caffeine or placebo is given in a pill form.

Group Type EXPERIMENTAL

2mg of Albuterol

Intervention Type DRUG

2mg of Albuterol on metabolic rate

4mg of Albuterol

Intervention Type DRUG

4mg of Albuterol on metabolic rate

100mg of Caffeine

Intervention Type DRUG

100mg of caffeine on metabolic rate

200mg of Caffeine

Intervention Type DRUG

200mg of Caffeine on metabolic rate

Albuterol 2mg & Caffeine 100mg

Intervention Type DRUG

Albuterol 2mg and 100mg of Caffeine

Albuterol 2mg and Caffeine 200mg

Intervention Type DRUG

Albuterol 2mg and Caffeine 200mg on metabolic rate

Albuterol 4mg and Caffeine 100mg

Intervention Type DRUG

Albuterol 4mg and Caffeine 100mg on metabolic rate

Albuterol 4mg and Caffeine 200mg

Intervention Type DRUG

Albuterol 4mg and Caffeine 200mg on metabolic rate

Caffeine 200mg

200mg of Caffeine or placebo is given in a pill form

Group Type EXPERIMENTAL

2mg of Albuterol

Intervention Type DRUG

2mg of Albuterol on metabolic rate

4mg of Albuterol

Intervention Type DRUG

4mg of Albuterol on metabolic rate

100mg of Caffeine

Intervention Type DRUG

100mg of caffeine on metabolic rate

200mg of Caffeine

Intervention Type DRUG

200mg of Caffeine on metabolic rate

Albuterol 2mg & Caffeine 100mg

Intervention Type DRUG

Albuterol 2mg and 100mg of Caffeine

Albuterol 2mg and Caffeine 200mg

Intervention Type DRUG

Albuterol 2mg and Caffeine 200mg on metabolic rate

Albuterol 4mg and Caffeine 100mg

Intervention Type DRUG

Albuterol 4mg and Caffeine 100mg on metabolic rate

Albuterol 4mg and Caffeine 200mg

Intervention Type DRUG

Albuterol 4mg and Caffeine 200mg on metabolic rate

Albuterol 2mg & Caffeine 100mg

100mg of Caffeine in combination with Albuterol 2mg or placebo is given in a pill form.

Group Type EXPERIMENTAL

4mg of Albuterol

Intervention Type DRUG

4mg of Albuterol on metabolic rate

100mg of Caffeine

Intervention Type DRUG

100mg of caffeine on metabolic rate

200mg of Caffeine

Intervention Type DRUG

200mg of Caffeine on metabolic rate

Albuterol 2mg & Caffeine 100mg

Intervention Type DRUG

Albuterol 2mg and 100mg of Caffeine

Albuterol 2mg and Caffeine 200mg

Intervention Type DRUG

Albuterol 2mg and Caffeine 200mg on metabolic rate

Albuterol 4mg and Caffeine 100mg

Intervention Type DRUG

Albuterol 4mg and Caffeine 100mg on metabolic rate

Albuterol 4mg and Caffeine 200mg

Intervention Type DRUG

Albuterol 4mg and Caffeine 200mg on metabolic rate

Albuterol 2mg and Caffeine 200mg

200mg of Caffeine in combination with Albuterol 2mg or placebo is given in a pill form.

Group Type EXPERIMENTAL

2mg of Albuterol

Intervention Type DRUG

2mg of Albuterol on metabolic rate

4mg of Albuterol

Intervention Type DRUG

4mg of Albuterol on metabolic rate

100mg of Caffeine

Intervention Type DRUG

100mg of caffeine on metabolic rate

200mg of Caffeine

Intervention Type DRUG

200mg of Caffeine on metabolic rate

Albuterol 2mg & Caffeine 100mg

Intervention Type DRUG

Albuterol 2mg and 100mg of Caffeine

Albuterol 2mg and Caffeine 200mg

Intervention Type DRUG

Albuterol 2mg and Caffeine 200mg on metabolic rate

Albuterol 4mg and Caffeine 100mg

Intervention Type DRUG

Albuterol 4mg and Caffeine 100mg on metabolic rate

Albuterol 4mg and Caffeine 200mg

Intervention Type DRUG

Albuterol 4mg and Caffeine 200mg on metabolic rate

Albuterol 4mg and Caffeine 100mg

100mg of Caffeine in combination with Albuterol 4mg or placebo is given in a pill form.

Group Type EXPERIMENTAL

2mg of Albuterol

Intervention Type DRUG

2mg of Albuterol on metabolic rate

4mg of Albuterol

Intervention Type DRUG

4mg of Albuterol on metabolic rate

100mg of Caffeine

Intervention Type DRUG

100mg of caffeine on metabolic rate

200mg of Caffeine

Intervention Type DRUG

200mg of Caffeine on metabolic rate

Albuterol 2mg & Caffeine 100mg

Intervention Type DRUG

Albuterol 2mg and 100mg of Caffeine

Albuterol 2mg and Caffeine 200mg

Intervention Type DRUG

Albuterol 2mg and Caffeine 200mg on metabolic rate

Albuterol 4mg and Caffeine 100mg

Intervention Type DRUG

Albuterol 4mg and Caffeine 100mg on metabolic rate

Albuterol 4mg and Caffeine 200mg

Intervention Type DRUG

Albuterol 4mg and Caffeine 200mg on metabolic rate

Albuterol 4mg and Caffeine 200mg

200mg of Caffeine in combination with Albuterol 4mg or placebo is given in a pill form.

Group Type EXPERIMENTAL

2mg of Albuterol

Intervention Type DRUG

2mg of Albuterol on metabolic rate

4mg of Albuterol

Intervention Type DRUG

4mg of Albuterol on metabolic rate

100mg of Caffeine

Intervention Type DRUG

100mg of caffeine on metabolic rate

200mg of Caffeine

Intervention Type DRUG

200mg of Caffeine on metabolic rate

Albuterol 2mg & Caffeine 100mg

Intervention Type DRUG

Albuterol 2mg and 100mg of Caffeine

Albuterol 2mg and Caffeine 200mg

Intervention Type DRUG

Albuterol 2mg and Caffeine 200mg on metabolic rate

Albuterol 4mg and Caffeine 100mg

Intervention Type DRUG

Albuterol 4mg and Caffeine 100mg on metabolic rate

Albuterol 4mg and Caffeine 200mg

Intervention Type DRUG

Albuterol 4mg and Caffeine 200mg on metabolic rate

Interventions

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2mg of Albuterol

2mg of Albuterol on metabolic rate

Intervention Type DRUG

4mg of Albuterol

4mg of Albuterol on metabolic rate

Intervention Type DRUG

100mg of Caffeine

100mg of caffeine on metabolic rate

Intervention Type DRUG

200mg of Caffeine

200mg of Caffeine on metabolic rate

Intervention Type DRUG

Albuterol 2mg & Caffeine 100mg

Albuterol 2mg and 100mg of Caffeine

Intervention Type DRUG

Albuterol 2mg and Caffeine 200mg

Albuterol 2mg and Caffeine 200mg on metabolic rate

Intervention Type DRUG

Albuterol 4mg and Caffeine 100mg

Albuterol 4mg and Caffeine 100mg on metabolic rate

Intervention Type DRUG

Albuterol 4mg and Caffeine 200mg

Albuterol 4mg and Caffeine 200mg on metabolic rate

Intervention Type DRUG

Other Intervention Names

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Albuterol Albuterol Caffeine Caffeine Caffeine Albuterol Albuterol Caffeine Albuterol Caffeine Albuterol Caffeine

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pennington Biomedical Research Center

OTHER

Sponsor Role lead

Responsible Party

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Frank Greenway

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Site Status

Countries

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United States

Other Identifiers

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PBRC 28026

Identifier Type: -

Identifier Source: org_study_id