Body Composition Changes With Albuterol and Caffeine Versus Placebo in Adolescents

NCT02740660 | Completed Results

• 1 other identifier: PBRC 2015-065
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Obesity

Keywords

Albuterol; Caffeine; Lean Body Mass; Fat Mass

Outcome Measures

Primary Outcomes (3)

• Change in Fat Mass With Caffeine/Albuterol

  DXA Scan of obese adolescents

  Baseline, Week 8

• Change in Lean Mass With Caffeine/Albuterol

  DXA Scan of obese adolescents

  Baseline, Week 8

• Change in Weight With Caffeine/Albuterol

  Baseline, Week 8

Secondary Outcomes (1)

• Number of Participants With Adverse Events

  Week 2, Week 4, Week 6, Week 8

Study Arms (2)

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.

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.

Drug: Placebo; Behavioral: Family weight management counseling

Interventions

Caffeine 100mg / Albuterol 4mg DRUG

Caffeine 100mg / Albuterol 4mg

Placebo DRUG

Placebo

Family weight management counseling BEHAVIORAL

Caffeine 100mg / Albuterol 4mg; Placebo

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy males or females with a BMI ≥ 95th percentile
• Between 12 and 17 years of age inclusive
• Tanner Stage III and above

You may not qualify if:

• 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

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• Leverage Innovation for Technology Transfer Fund (LSU LIFT2): collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808-4124, United States

Location

Related Publications (3)

• 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.

  PMID: 26239482 BACKGROUND

• 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.

  PMID: 17942817 BACKGROUND

• 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.

  PMID: 15705021 BACKGROUND

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Caffeine; Albuterol

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Limitations and Caveats

This was a pilot study with a small number of participants. Diet and physical activity was not controlled in this pilot study.

Results Point of Contact

• Title: Dr. Daniel Hsia
• Organization: Pennington Biomedical Research Center

clinicaltrials@pbrc.edu

225-763-3000

Study Officials

• Daniel Hsia, PhD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 7, 2016
• First Posted: April 15, 2016
• Study Start: April 1, 2016
• Primary Completion: October 24, 2017
• Study Completion: October 31, 2017
• Last Updated: October 8, 2019
• Results First Posted: September 25, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)