Ignite Creation Date:
2024-05-06 @ 8:28 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02740660
Status:
COMPLETED
Last Update Posted:
2019-10-08
First Post:
2016-04-07
Brief Title:
Body Composition Changes With Albuterol and Caffeine Versus Placebo in Adolescents
Sponsor:
Pennington Biomedical Research Center
Organization:
Pennington Biomedical Research Center
Study Overview
Official Title:
Effect on Body Composition With Albuterol and Caffeine Versus Placebo in Adolescents A Pilot Study
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAMP
Brief 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 childs 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 125 and decreased fat mass by 12 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 125 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
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 125 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None