The Long-term Effects of Oceanix™ on Resistance Training Adaptations
Condition: Oxidative Stress; Muscle Strength; Resistance Training; Body Composition; Muscle Damage
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      Secondary Variables

        -  CBC, CMP, Urinalysis

        -  Vital signs (blood pressure)

        -  Adverse Events Scale

        -  PRS and RPE scales

      At the end of weeks 2 and 5 participants will be examined for their perceived recovery,
      soreness, serum markers of muscle damage (creatine kinase), and oxidative stress markers (SOD
      and Total Antioxidant Status). The rationale for the time points is to introduce extreme
      stressors in the early and late stages of the training protocol. Variables collected at these
      time points are described below.

      Secondary variables

        -  Muscle damage (blood creatine kinase), soreness, and recovery.

        -  Immune function (IGA) , endocrine function (cortisol and testosterone), and oxidative
           stress (SOD and total antioxidant status).

        -  PRS scale
    

Intervention name(s): Oceanix; Resistance Training
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Ingredient contains highly active antioxidant enzymes, including superoxide dismutase (SOD), as well as essential fatty acids, vitamins, amino acids and minerals.; 6 weeks of supervised and programmed whole body resistance training, performed 3-5 times per week.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blind, parallel, randomized, placebo-controlled trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Oxidative Stress; Muscle Strength; Resistance Training; Antioxidants