The Long-term Effects of Oceanix™ Supplementation on Oxidative Stress, Performance, Body Composition and Safety Metrics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Changes in muscle power
研究概览
简要总结
This study will examine the effects of Oceanix™, an antioxidant supplement, on muscle performance, immune and endocrine function, recovery and safety in participants undergoing resistance training. Measures of muscle performance will include isometric testing in the bench-press and mid-thigh pull and ground reaction forces in the counter movement- and squat-jump. Markers of immune function will include salivary immunoglobulin A (IgA) as well as serum total antioxidant capacity (TAC) and superoxide dismutase (SOD) while endocrine function will be measured by salivary cortisol and testosterone. Recovery will be measure by plasma creatine kinase (CK) and perceptual measures will be assessed using a validated perceived recovery status (PRS) scale. Safety metrics will be indicated by a comprehensive metabolic panel (CMP), complete blood count (CBC), and urinalysis (UA). Additionally, the modified Borg Rating of Perceived Exertion (RPE) will be administered following each training session to grade physical exertion and monitor progression of the training protocol.
详细描述
This study will examine the effects of Oceanix™, an antioxidant supplement, on muscle performance, immune and endocrine function, recovery and safety in participants undergoing resistance training. Measures of muscle performance will include isometric testing in the bench-press and mid-thigh pull and ground reaction forces in the counter movement- and squat-jump. Markers of immune function will include salivary immunoglobulin A (IgA) as well as serum total antioxidant capacity (TAC) and superoxide dismutase (SOD) while endocrine function will be measured by salivary cortisol and testosterone. Recovery will be measure by plasma creatine kinase (CK) and perceptual measures will be assessed using a validated perceived recovery status (PRS) scale. Safety metrics will be indicated by a comprehensive metabolic panel (CMP), complete blood count (CBC), and urinalysis (UA). Additionally, the modified Borg Rating of Perceived Exertion (RPE) will be administered following each training session to grade physical exertion and monitor progression of the training protocol.
This study will be a double blind parallel, randomized placebo-controlled trial. The investigators will request participation from 25 male and female participants (40-60 % mixture of each) ranging from 18 to 45 years old who are active (i.e. 30 minutes per week of vigorous activity classified as greater than 75 % of their HR max 3 days • week-1). The exclusion criteria will include having a BMI of 30 or more kg/m²; having cardiovascular, metabolic, or endocrine disease; undergone surgery that affects digestion and absorption, smoking, drinking heavily (> 7 and > 14 drinks per week for women and men, respectively), women who are pregnant or planning to be pregnant; taking medication to control blood pressure, lipids, and blood glucose; have taken or currently taking anabolic-androgenic steroids. The investigators will also exclude individuals using antioxidant supplements, NSAIDS, or nutritional supplements known to stimulate recovery or muscle mass gains, heart disease, prescription medications, dietary supplements that enhance body strength, muscle, immune function, muscle recovery, or soreness. Additionally, individuals cannot have allergies for seaweeds or marine sources or any dietary supplements or take any psychiatric supplements or blood thinners.
Participants will be baselined and post-tested at week zero and again after 6 weeks of training, respectively. However, on weeks 2 and 5, participants will experience an overreaching phase to induce stress, and run through specific tests to gauge recovery at the end of those specific weeks. Variables collected at these time points are described below.
Primary variables:
- Muscle, fat mass, and bone density as indicated on DXA
- Upper body strength, velocity, and power on the bench press.
- Lower body strength and power on a dual force plate.
- Vertical jump performance on a dual force plate.
- Movement mechanics and stability using a combination of motion analysis and a dual force plate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Physically active males and females aged 18 to 45 years.
- •Volunteers are deemed active if they engage in 30 minutes of vigorous activity, classified as greater than 75 % of their HR max, 3 days • week-1.
排除标准
- •> BMI of 30 or more kg/m²
- •Cardiovascular, metabolic, or endocrine disease
- •Undergone surgery that affects digestion and absorption
- •Drinking heavily (> 7 and > 14 drinks per week for women and men, respectively)
- •Women who are pregnant or planning to be pregnant
- •Taking medication to control blood pressure, lipids, and blood glucose
- •Have taken or currently taking anabolic-androgenic steroids
- •Individuals using antioxidant supplements, NSAIDS, or nutritional supplements known to stimulate recovery or muscle mass gains, heart disease, prescription medications, dietary supplements that enhance body strength, muscle, immune function, muscle recovery, or soreness
- •Allergies for seaweeds or marine sources
结局指标
主要结局
Changes in muscle power
时间窗: Pre, Week 2, Week 5, Week 6
Assessed through ground reaction forces during countermovement- and squat-jumps on a force plate.
Creatine Kinase (CK)
时间窗: Pre, Week 2, Week 5, Week 6
Experimental outcome examining creatine kinase in fasted whole blood samples. This is biomarker an indirect measure of muscle damage.
Changes in muscle strength
时间窗: Pre, Week 2, Week 5, Week 6
Assessed by isometric mid-thigh pull and isometric bench-press
Superoxide Dimutase (SOD)
时间窗: Pre, Week 2, Week 5, Week 6
Experimental outcome examining superoxide dimutase in fasted whole blood samples. This is another protective antioxidant enzyme measured from whole blood.
Total Antioxidant Capacity (TAC)
时间窗: Pre, Week 2, Week 5, Week 6
Experimental outcome examining total antioxidant capacity in fasted whole blood samples. The TAC measures the overall collective power of the blood to neutralize free radicals.
Body Composition
时间窗: Pre and Week 6
Body Composition will be assessed via dual-energy x-ray absorptiometry (DXA). Using this method, changes in total-, lean-, and fat-mass will be examined.
次要结局
- Testosterone(Pre, Week 2, Week 5, Week 6)
- Comprehensive Metabolic Panel(Pre and Week 6)
- Urinalysis(Pre and Week 6.)
- Immunoglobulin A (IgA)(Pre, Week 2, Week 5, Week 6)
- Cortisol(Pre, Week 2, Week 5, Week 6)
- Rating of Perceived Exertion (RPE)(Following every resistance training session throughout the study.)
- Perceived Recovery Status (PRS)(Prior to every resistance training session throughout the study.)
- Complete Blood Count(Pre and Week 6)
