Body Composition Changes With Albuterol and Caffeine Versus Placebo in Adolescents

Launched by PENNINGTON BIOMEDICAL RESEARCH CENTER · Apr 12, 2016

Keywords

ClinConnect Summary

Previous studies done at Pennington Biomedical have demonstrated that the equivalent of oral albuterol 4mg three times a day (tid) with oral caffeine 100mg tid reduces body fat and increases lean tissue in rodents more than the addition of the effect of the two components separately. The combination of albuterol with caffeine changed body composition without changing food intake. An adult male taking albuterol 4 mg orally tid plus caffeine 100mg orally tid increased lean mass by 1.25% and decreased fat mass by 1.2% over a two month period. These effects are expected to be even greater in a ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Healthy males or females with a BMI ≥ 95th percentile
• • Between 12 and 17 years of age inclusive
• • Tanner Stage III and above
• Exclusion Criteria:
• • Weigh less than 50 kg
• • Have a family history of sudden death or hypertrophic cardiomyopathy
• • Have a history of unexplained syncope
• • Have a marked baseline prolongation of QT/QTc interval (QTc interval \>450 ms), a history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome), or use concomitant medications that prolong the QT/QTc interval
• • Have history of asthma, hypertension, thyroid disease, or significant neurologic disease such as seizure disorder
• • Are pregnant, planning to become pregnant, or nursing. Females who are sexually active must be using adequate contraception.
• • Take a medication known to affect weight or body composition like systemic glucocorticoids, atypical anti-psychotics, or weight loss medications
• • Take beta-stimulators or beta-blockers on a regular basis
• • Take stimulants for attention deficit disorder
• • Take monoamine oxidase inhibitors, tricyclic antidepressants, or diuretics
• • Take any chronic medication that has not had a stable dose for 1 month or longer
• • Have type 1 or type 2 diabetes
• • Have any significant cardiac disease (such as heart failure, arrhythmias, or valve disease), uncontrolled pulmonary disease, chronic liver disease, chronic kidney disease, or chronic infectious disease
• • Have any significant psychiatric illness that is unstable or untreated such as bipolar disorder, severe depression, or severe anxiety
• • Have a history of suicidal ideation
• • Have an allergy or hypersensitivity to albuterol
• • Are unwilling to discontinue caffeine-containing products while in the study
• • Are deemed unfit to participate in the study based on evaluation by the medical investigator