Body Composition Changes With Albuterol and Caffeine Versus Placebo in Adolescents
Condition: Pediatric Obesity
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether taking a combination of caffeine and
      albuterol three times per day will increase muscle and decrease fat in your child's body and
      to determine how these medications make your child feel. Albuterol is approved by the FDA for
      the treatment of asthma. It is not approved to increase muscle and decrease body fat in
      children.
    

Detailed description: 
      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 growing adolescent. This pilot
      project will take the first step towards trying to understanding the safety and potential
      efficacy of this drug combination. The prospect of using inexpensive medications already
      approved in the pediatric population for the treatment of asthma as a novel treatment for
      adolescent obesity addresses a medical need that is presently unmet.

      Food restriction in adolescence is not only difficult to accomplish, but it also raises
      concerns about growth and development. A medication approved for the treatment of obesity in
      the adolescent age group that improves body composition by reducing body fat and increasing
      lean tissue without needing to restrict food intake would be a useful tool for physicians who
      address the treatment of obesity in adolescents. Albuterol is a medication, approved for ages
      6 and older, used for the treatment of asthma and has also been shown to increase muscle
      strength and lean body mass in children with spinal muscular atrophy and in healthy young men
      during an exercise training program. A drug approved for the treatment of adolescent obesity
      that increases lean tissue, decreases fat tissue and can be given in conjunction with
      lifestyle modifications would be welcomed by both pediatricians who treat these adolescents
      and by adolescents who are stigmatized by their obesity.

      A provisional patent has been submitted by Pennington Biomedical Research Center to protect
      the combination of caffeine and albuterol in a 1:25 ratio for synergistically increasing
      muscle mass and decreasing fat mass as a potential treatment for obesity in adolescents.

      This study will be a double-blinded, randomized, placebo-controlled, pilot study in which
      subjects will be randomized to receive either placebo or a combination of Albuterol 4 mg and
      Caffeine 100mg three times per day orally for a total of 8 weeks. Each subject will continue
      on the study intervention for the entire duration of treatment
    

Intervention name(s): Caffeine 100mg / Albuterol 4mg; Placebo; Family weight management counseling
Intervention type(s): Drug; Drug; Behavioral
Intervention MeSH terms: Caffeine; Albuterol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Albuterol; Caffeine; Lean Body Mass; Fat Mass