Trial record 9 of 13 for:    ACETAMINOPHEN METABOLISM

Acetaminophen and Impaired Musculoskeletal Adaptations to Exercise Training

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01083901
First received: March 8, 2010
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

The purpose of this study is to determine if taking the pain reliever acetaminophen (ACET) interferes with some of the benefits of weight lifting on muscles and bone density in older men.


Condition Intervention
Sarcopenia
Osteoporosis
Aging
Behavioral: Resistance training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: Acetaminophen and Impaired Musculoskeletal Adaptations to Exercise Training

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Change in Total Body Fat-free Mass [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    change from baseline to 16 weeks in fat-free mass measured by DXA (Hologic Discovery W, version 12.6)


Secondary Outcome Measures:
  • Change in Total Body Fat Mass [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Change from baseline to 16 weeks in total body fat mass.

  • Changes in Upper Body Strength. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Strength was measured using the one-repetition maximum method. Upper body strength was a composite of bench press, overhead press, seated row, and lateral pull-down strength.

  • Change in Lower Body Strength [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Strength was measured using the one-repetition maximum method. Lower body strength was a composite of knee flexion, knee extension, and leg press strength.


Enrollment: 34
Study Start Date: May 2006
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Resistance training with Acetaminophen
Acetaminophen
Behavioral: Resistance training
high intensity progressive resistance exercise training
Experimental: Resistance Training with ibuprofen
Ibuprofen
Behavioral: Resistance training
high intensity progressive resistance exercise training
Placebo Comparator: placebo
Placebo
Behavioral: Resistance training
high intensity progressive resistance exercise training

Detailed Description:

The commonly used pain relievers acetaminophen and ibuprofen may impair musculoskeletal adaptations to progressive resistance exercise training by inhibiting exercise-induced muscle protein synthesis.

To test the hypothesis that acetaminophen and ibuprofen would diminish training-induced increases in fat-free mass, untrained men (n=26) aged ≥ 50 years participated in 16 weeks of high-intensity progressive resistance exercise training and bone-loading exercises and were randomly assigned to take ACET (1000 mg), ibuprofen (400 mg) or placebo 2 hours before each exercise session.

The primary outcome was the change in total body fat-free mass measured by dual-energy X-ray absorptiometry (DXA) at baseline and week 16. Our primary interest was in the comparison of the acetaminophen and placebo groups.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • average use of acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs) [including aspirin] less than 3 days per month
  • not currently engaged in moderate-to-vigorous weight-lifting exercise
  • non-smoker
  • willing to participate in a supervised exercise program for 9 months

Exclusion Criteria:

  • relative or absolute contraindications to regular use of acetaminophen or NSAIDs including known allergy or intolerance to either drug,history of peptic ulcer or GI bleeding, anemia, asthma with bronchospasm induced by aspirin or other NSAIDS, moderate or severe renal impairment, known hepatobiliary disease
  • contraindications to exercise testing and training including congestive heart failure class III or IV, uncontrolled hypertension and unstable cardiovascular disease
  • thyroid dysfunction
  • orthopedic problems that limit the ability to perform vigorous exercise or increase the likelihood of the use of pain medications
  • drugs known to alter bone metabolism
  • allergy to lidocaine
  • diabetes mellitus requiring pharmacologic therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01083901

Locations
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Catherine Jankowski, PhD University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01083901     History of Changes
Other Study ID Numbers: 06-0343, R21AG027809
Study First Received: March 8, 2010
Results First Received: February 4, 2013
Last Updated: June 17, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Osteoporosis
Sarcopenia
Bone Diseases
Musculoskeletal Diseases
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms
Acetaminophen
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014