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Body Composition Changes With Albuterol and Caffeine Versus Placebo in Adolescents (CAMP)

Primary Purpose

Pediatric Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Caffeine 100mg / Albuterol 4mg
Placebo
Family weight management counseling
Sponsored by
Pennington Biomedical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Obesity focused on measuring Albuterol, Caffeine, Lean Body Mass, Fat Mass

Eligibility Criteria

12 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Pennington Biomedical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Caffeine 100mg / Albuterol 4mg

Placebo

Arm Description

One capsule 3 times per day orally for a total of 8 weeks and family weight management counseling for a total of 8 weeks.

One capsule 3 times per day orally for a total of 8 weeks and family weight management counseling for a total of 8 weeks.

Outcomes

Primary Outcome Measures

Change in Fat Mass With Caffeine/Albuterol
DXA Scan of obese adolescents
Change in Lean Mass With Caffeine/Albuterol
DXA Scan of obese adolescents
Change in Weight With Caffeine/Albuterol

Secondary Outcome Measures

Number of Participants With Adverse Events

Full Information

First Posted
April 7, 2016
Last Updated
September 25, 2019
Sponsor
Pennington Biomedical Research Center
Collaborators
Leverage Innovation for Technology Transfer Fund (LSU LIFT2)
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1. Study Identification

Unique Protocol Identification Number
NCT02740660
Brief Title
Body Composition Changes With Albuterol and Caffeine Versus Placebo in Adolescents
Acronym
CAMP
Official Title
Effect on Body Composition With Albuterol and Caffeine Versus Placebo in Adolescents: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
October 24, 2017 (Actual)
Study Completion Date
October 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pennington Biomedical Research Center
Collaborators
Leverage Innovation for Technology Transfer Fund (LSU LIFT2)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity
Keywords
Albuterol, Caffeine, Lean Body Mass, Fat Mass

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Caffeine 100mg / Albuterol 4mg
Arm Type
Experimental
Arm Description
One capsule 3 times per day orally for a total of 8 weeks and family weight management counseling for a total of 8 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
One capsule 3 times per day orally for a total of 8 weeks and family weight management counseling for a total of 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Caffeine 100mg / Albuterol 4mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Behavioral
Intervention Name(s)
Family weight management counseling
Primary Outcome Measure Information:
Title
Change in Fat Mass With Caffeine/Albuterol
Description
DXA Scan of obese adolescents
Time Frame
Baseline, Week 8
Title
Change in Lean Mass With Caffeine/Albuterol
Description
DXA Scan of obese adolescents
Time Frame
Baseline, Week 8
Title
Change in Weight With Caffeine/Albuterol
Time Frame
Baseline, Week 8
Secondary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Time Frame
Week 2, Week 4, Week 6, Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Hsia, PhD
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808-4124
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26239482
Citation
Liu AG, Arceneaux KP 3rd, Chu JT, Jacob G Jr, Schreiber AL, Tipton RC, Yu Y, Johnson WD, Greenway FL, Primeaux SD. The effect of caffeine and albuterol on body composition and metabolic rate. Obesity (Silver Spring). 2015 Sep;23(9):1830-5. doi: 10.1002/oby.21163. Epub 2015 Aug 4.
Results Reference
background
PubMed Identifier
17942817
Citation
Skura CL, Fowler EG, Wetzel GT, Graves M, Spencer MJ. Albuterol increases lean body mass in ambulatory boys with Duchenne or Becker muscular dystrophy. Neurology. 2008 Jan 8;70(2):137-43. doi: 10.1212/01.WNL.0000287070.00149.a9. Epub 2007 Oct 17.
Results Reference
background
PubMed Identifier
15705021
Citation
Caruso JF, Hamill JL, De Garmo N. Oral albuterol dosing during the latter stages of a resistance exercise program. J Strength Cond Res. 2005 Feb;19(1):102-7. doi: 10.1519/R-14793.1.
Results Reference
background

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Body Composition Changes With Albuterol and Caffeine Versus Placebo in Adolescents

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