Bone Resorption, Stress Fracture, Bone Injury
Conditions
Brief summary
The purpose of this study is to determine the effects of a single dose of non-steroidal anti-inflammatory drugs on post-exercise markers of bone and muscle metabolism.
Detailed description
This protocol intends to determine how consuming a single dose of a non-steroidal anti-inflammatory drug (NSAID) affects circulating bone metabolism biomarkers and markers of damage skeletal muscle in response to a bout of plyometric exercise. This will be accomplished using a four trial, placebo-controlled crossover design with trials examining ibuprofen, celecoxib, flurbiprofen and placebo. These particular NSAIDs were chosen because of their widespread use in military populations and differing molecular mechanisms, which could cause differing effects on bone and muscle. Two hours after of consuming a single dose of an NSAID, participants will perform 10 sets of 10 plyometric jumps to induce a mechanical loading stimulus the bone and muscle tissues. Blood, urine, and muscle biopsy samples will be collected before and up to four hours after exercise. Biomarkers representing bone and muscle metabolism will determine the magnitude of adaptive responses to plyometric exercise while using NSAIDs.
Interventions
DRUGIbuprofen 800 mg
Ibuprofen taken orally 2 hours prior to exercise
DRUGCelecoxib 200mg
Celebrex taken orally 2 hours prior to exercise
Flurbiprofen taken orally 2 hours prior to exercise
DRUGPlacebo
Inert placebo taken orally 2 hours prior to exercise
Sponsors
United States Army Research Institute of Environmental Medicine
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
4 trial, block randomized crossover design. Three NSAIDs and one placebo trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 42 Years
Healthy volunteers
Yes
Inclusion criteria
* Must currently exercise at least 2 times per week * Must be willing to discontinue the use of nutritional supplements, alcohol and nicotine during each study period (4 trials of 5 consecutive days each), unless approved by PI * Must be willing to refrain from taking NSAIDs and similar medications during the course of the study (other than those given by the study team) * Weigh at least 110 lbs and have a hemoglobin of 12.5 g/dL or higher
Exclusion criteria
* Known allergic reaction to any NSAID type medication * History of gastrointestinal disorders/discomfort associated with or which may be aggravated with NSAID use * History or known gastric ulcer * History of endocrine disorders (e.g., diabetes, uncontrolled thyroid dysfunction, hypoparathyroidism, or hyperparathyroidism) * History of bone-modifying disorder (e.g., osteogenesis imperfecta, osteoporosis, or rickets) * Diagnosed bone fracture within last 6 months * History of cardiovascular or renal diseases * Pregnant or lactation in the last 6 months * Currently taking or history of routine use of medications known to affect bone or calcium metabolism (e.g., thiazide diuretics, bisphosphonates, oral steroids) * History of back or shoulder injury which may be aggravated by exercise * Blood donation within 8 weeks of the study * Current physical illness or injury limiting physical activity * Known allergy to lidocaine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline circulating marker of bone formation | Change from pre-exercise to 4 hours post-exercise | Concentration (pg/mL) of serum N-terminal propeptide of type 1 collagen (P1NP) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline circulating marker of bone resorption | Change from pre-exercise to 4 hours post-exercise | Concentration (pg/mL) of serum C-terminal propeptide of type I collagen (CTX) |
| Markers of muscle inflammation | Change from pre-exercise to 3 hours post-exercise | Interlukin-6 (IL-6), Interlukin-10 (IL-10), and tissue necrosis factor (TNF-a) messenger ribonucleic acid (mRNA) concentration in muscle biopsy tissue |
Other
| Measure | Time frame | Description |
|---|---|---|
| Muscle protein synthesis | Change from pre-exercise to 3 hours post-exercise | ribosomal protein S6 (p-RPS6) protein concentration in muscle biopsy tissue |
Countries
United States
Outcome results
None listed