Oxidative Stress Clinical Trial
Official title:
The Long-term Effects of Oceanix™ Supplementation on Oxidative Stress, Performance, Body Composition and Safety Metrics
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 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
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