Pediatric ObesityCAMPNCT02740660
Body Composition Changes With Albuterol and Caffeine Versus Placebo in Adolescents
A study testing Caffeine 100mg / Albuterol 4mg and Family weight management counseling in people with Pediatric Obesity, run by Pennington Biomedical Research Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- Caffeine 100mg / Albuterol 4mg and Family weight management counseling
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 31 Oct 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy males or females with a BMI ≥ 95th percentile
- Between 12 and 17 years of age inclusive
- Tanner Stage III and above
Who cannot join
- 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.
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808-4124
About this study
Official title: 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.
Read the 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
- Conditions
- Pediatric Obesity
- Being tested
- Caffeine 100mg / Albuterol 4mg, Placebo, Family weight management counseling
- Keywords
- Albuterol, Caffeine, Lean Body Mass, Fat Mass
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caffeine 100mg / Albuterol 4mgDrug
PlaceboDrug
Family weight management counselingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Caffeine 100mg / Albuterol 4mg | Experimental | One capsule 3 times per day orally for a total of 8 weeks and family weight management counseling for a total of 8 weeks. Receives: Drug: Caffeine 100mg / Albuterol 4mg; Behavioral: Family weight management counseling |
| Placebo | Placebo comparator | One capsule 3 times per day orally for a total of 8 weeks and family weight management counseling for a total of 8 weeks. Receives: Drug: Placebo; Behavioral: Family weight management counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fat Mass With Caffeine/Albuterol
DXA Scan of obese adolescents
Measured: Baseline, Week 8
Change in Lean Mass With Caffeine/Albuterol
DXA Scan of obese adolescents
Measured: Baseline, Week 8
Change in Weight With Caffeine/Albuterol
Measured: Baseline, Week 8
Secondary outcomes (1)
Number of Participants With Adverse Events
Measured: Week 2, Week 4, Week 6, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startApr 2016
- Primary completion24 Oct 2017
- Study completion31 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Leverage Innovation for Technology Transfer Fund (LSU LIFT2)
- Responsible party
- Principal investigator, Daniel Hsia, Pennington Biomedical Research Center
- Investigators
- Daniel Hsia, PhD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02740660
- Sponsor's protocol ID
- PBRC 2015-065
- Acronym
- CAMP
- Status last verified
- Sep 2019
- First submitted
- 7 Apr 2016
- Last updated
- 8 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 26239482Skura 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.
PubMed 17942817Caruso 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.
PubMed 15705021
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect on Body Composition With Albuterol and Caffeine Versus Placebo in Adolescents: A Pilot Study
- ClinicalTrials.gov ID
- NCT02740660
- Acronym / sponsor ID
- CAMP / PBRC 2015-065
- Conditions
- Pediatric Obesity
- Keywords
- Albuterol, Caffeine, Lean Body Mass, Fat Mass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- Leverage Innovation for Technology Transfer Fund (LSU LIFT2)
- Study start
- Apr 2016
- Primary completion
- 24 Oct 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 15 Apr 2016 (estimated)
- Results
- Posted 25 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caffeine 100mg / Albuterol 4mg | Experimental | Drug: Caffeine 100mg / Albuterol 4mg, Behavioral: Family weight management counselingOne capsule 3 times per day orally for a total of 8 weeks and family weight management counseling for a total of 8 weeks. |
| Placebo | Placebo comparator | Drug: Placebo, Behavioral: Family weight management counselingOne capsule 3 times per day orally for a total of 8 weeks and family weight management counseling for a total of 8 weeks. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy males or females with a BMI ≥ 95th percentile
- Between 12 and 17 years of age inclusive
- Tanner Stage III and above
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caffeine 100mg / Albuterol 4mg | Drug | Caffeine 100mg / Albuterol 4mg |
| Placebo | Drug | Placebo |
| Family weight management counseling | Behavioural | Caffeine 100mg / Albuterol 4mg, Placebo |
Primary outcome
Change in Fat Mass With Caffeine/Albuterol
Time frame: Baseline, Week 8
DXA Scan of obese adolescents
Change in Lean Mass With Caffeine/Albuterol
Time frame: Baseline, Week 8
DXA Scan of obese adolescents
Change in Weight With Caffeine/Albuterol
Time frame: Baseline, Week 8
1 secondary outcome
Number of Participants With Adverse Events
Time frame: Week 2, Week 4, Week 6, Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26239482Liu 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.
- Background: PubMed 17942817Skura 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.
- Background: PubMed 15705021Caruso 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Hsia, PhD principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caffeine 100mg / Albuterol 4mg and Family weight management counseling in people with Pediatric Obesity, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fat Mass With Caffeine/Albuterol (time frame: Baseline, Week 8). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02740660, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2019.