The Effects of Non-steroidal Anti-inflammatory Drugs on Circulating Markers of Bone Metabolism Following Plyometric Exercise in Humans
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change from baseline circulating marker of bone formation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Celecoxib
Participants will consume a single dose of celecoxib prior to a plyometric exercise bout
干预措施: Celecoxib 200mg (Drug)
Ibuprofen
Participants will consume a single dose of ibuprofen prior to a plyometric exercise bout
干预措施: Ibuprofen 800 mg (Drug)
Flurbiprofen
Participants will consume a single dose of flurbiprofen prior to a plyometric exercise bout
干预措施: Flurbiprofen 100 mg (Drug)
Placebo
Participants will consume a single dose of an inert placebo prior to a plyometric exercise bout
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline circulating marker of bone formation
时间窗: Change from pre-exercise to 4 hours post-exercise
Concentration (pg/mL) of serum N-terminal propeptide of type 1 collagen (P1NP)
次要结局
- Change from baseline circulating marker of bone resorption(Change from pre-exercise to 4 hours post-exercise)
- Markers of muscle inflammation(Change from pre-exercise to 3 hours post-exercise)
研究者
Jeffery Staab
Principal Investigator
United States Army Research Institute of Environmental Medicine