Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04136821
Study type Interventional
Source Applied Science & Performance Institute
Contact
Status Completed
Phase N/A
Start date September 30, 2019
Completion date January 31, 2020

See also
  Status Clinical Trial Phase
Completed NCT03255187 - Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution N/A
Recruiting NCT03790345 - Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics Phase 2/Phase 3
Completed NCT03358524 - Effects of Vitamin E Supplementation on Free Radicals and Fat Level of Obese Adolescence in Jakarta, Indonesia Phase 4
Recruiting NCT05327348 - Effectiveness of IV Vitamin C in Reducing Oxidative Stress Associated With Free Flap Surgery Phase 3
Completed NCT03288623 - The Effects of Dark Chocolate Implementation in Elite Athletes N/A
Completed NCT04419025 - Efficacy of N-Acetylcysteine (NAC) in Preventing COVID-19 From Progressing to Severe Disease Phase 2
Completed NCT04597983 - Effect of 8-week Intake of 2S-hesperidin on Performance, Body Composition and Biochemicals Markers in Amateur Cyclists N/A
Enrolling by invitation NCT03030456 - Whole Body Vibrations on Functional Capacity, Muscular Strength, and Biochemical Profile in Elders N/A
Completed NCT02256254 - SIMOX - Induction of Oxidative Stress Phase 2
Not yet recruiting NCT02202239 - Effect of Induction and Maintenance of Anesthesia With Etomidate on Hemodynamics and Oxidative Stress in Diabetic Patients Phase 4
Recruiting NCT02048592 - Impact of Immunonutrition on the Patients With Cystic Fibrosis Phase 4
Completed NCT01942460 - Ferumoxytol for Iron-Deficiency Anemia in Chronic Kidney Disease and Peritoneal Dialysis Patients Phase 4
Completed NCT02463318 - The Effect of Melatonin on Gene Expression and Activity of the Sirt1 and Its Target Genes Catalase and MnSOD in Multiple Sclerosis Patients and Healthy Subjects N/A
Completed NCT01990391 - Brazil Nut Consumption in Microvascular Endothelial Function, Oxidative Stress and Metabolic Abnormalities N/A
Completed NCT02177383 - Action of Essential Fatty Acids on the Expression of Antioxidant Genes and Athletic Performance N/A
Completed NCT00845130 - Quantitative in Vivo Biomarkers of Oxidative Stress in Diabetes N/A
Completed NCT00607893 - Efficacy of Continuous Positive Airway Pressure in Reducing Oxidative Stress in Individuals With Sleep Apnea N/A
Active, not recruiting NCT00247507 - The Effects of Acetylcysteine on Alleviating Damage of Oxidative Stress in Hemodialysis Patients Phase 4
Completed NCT03697499 - Effects of Fish Oil in Alleviating Health Hazards Associated With Ozone Exposure N/A
Completed NCT04177641 - Evaluation of Thioldisulfide Balance in Cervical Preinvasive Lesions