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

September 25, 2019 updated by: Daniel Hsia, Pennington Biomedical Research Center

Effect on Body Composition With Albuterol and Caffeine Versus Placebo in Adolescents: A Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808-4124
        • Pennington Biomedical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Caffeine 100mg / Albuterol 4mg
One capsule 3 times per day orally for a total of 8 weeks and family weight management counseling for a total of 8 weeks.
Drug: Caffeine 100mg / Albuterol 4mg
Behavioral: Family weight management counseling
Placebo Comparator: Placebo
One capsule 3 times per day orally for a total of 8 weeks and family weight management counseling for a total of 8 weeks.
Drug: Placebo
Behavioral: Family weight management counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fat Mass With Caffeine/Albuterol
Time Frame: Baseline, Week 8
DXA Scan of obese adolescents
Baseline, Week 8
Change in Lean Mass With Caffeine/Albuterol
Time Frame: Baseline, Week 8
DXA Scan of obese adolescents
Baseline, Week 8
Change in Weight With Caffeine/Albuterol
Time Frame: Baseline, Week 8
Baseline, Week 8

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Adverse Events
Time Frame: Week 2, Week 4, Week 6, Week 8
Week 2, Week 4, Week 6, Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pennington Biomedical Research Center

Collaborators

Leverage Innovation for Technology Transfer Fund (LSU LIFT2)

Investigators

  • Principal Investigator: Daniel Hsia, PhD, Pennington Biomedical Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

October 24, 2017

Study Completion (Actual)

October 31, 2017

Study Registration Dates

First Submitted

April 7, 2016

First Submitted That Met QC Criteria

April 12, 2016

First Posted (Estimate)

April 15, 2016

Study Record Updates

Last Update Posted (Actual)

October 8, 2019

Last Update Submitted That Met QC Criteria

September 25, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PBRC 2015-065

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pediatric Obesity

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe