The Long-term Effects of Oceanix™ on Resistance Training Adaptations

Oxidative Stress Clinical Trial

Official title:

The Long-term Effects of Oceanix™ Supplementation on Oxidative Stress, Performance, Body Composition and Safety Metrics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04136821
• Other study ID #: ASPI0519
• Status: Completed
• Phase: N/A
• Start date: September 30, 2019
• Est. completion date: January 31, 2020

Study information

• Verified date: February 2020
• Source: Applied Science & Performance Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 31, 2020
• Est. primary completion date: November 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• > BMI of 30 or more kg/m²

• 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

• 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

Related Conditions & MeSH terms

• Body Composition
• Muscle Damage
• Muscle Strength
• Oxidative Stress
• Resistance Training

Intervention

Dietary Supplement:
• Oceanix
Ingredient contains highly active antioxidant enzymes, including superoxide dismutase (SOD), as well as essential fatty acids, vitamins, amino acids and minerals.

Other:
• Resistance Training
6 weeks of supervised and programmed whole body resistance training, performed 3-5 times per week.

Locations

Country	Name	City	State
United States	Applied Science & Performance Institute	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Applied Science & Performance Institute	Lonza Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Resting Systolic Blood Pressure	Change in resting systolic blood pressure.	Pre and Week 6
Other	Resting Diastolic Blood Pressure	Change in resting diastolic blood pressure.	Pre and Week 6
Primary	Changes in muscle strength	Assessed by isometric mid-thigh pull and isometric bench-press	Pre, Week 2, Week 5, Week 6
Primary	Changes in muscle power	Assessed through ground reaction forces during countermovement- and squat-jumps on a force plate.	Pre, Week 2, Week 5, Week 6
Primary	Total Antioxidant Capacity (TAC)	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.	Pre, Week 2, Week 5, Week 6
Primary	Superoxide Dimutase (SOD)	Experimental outcome examining superoxide dimutase in fasted whole blood samples. This is another protective antioxidant enzyme measured from whole blood.	Pre, Week 2, Week 5, Week 6
Primary	Creatine Kinase (CK)	Experimental outcome examining creatine kinase in fasted whole blood samples. This is biomarker an indirect measure of muscle damage.	Pre, Week 2, Week 5, Week 6
Primary	Body Composition	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.	Pre and Week 6
Secondary	Rating of Perceived Exertion (RPE)	Assessed through a visual analog scale (modified Borg Scale) numbered 0-10 with visual descriptors. For example, at 0 the descriptor is "rest" and at 10 the descriptor is "maximal exertion".	Following every resistance training session throughout the study.
Secondary	Perceived Recovery Status (PRS)	Assessed through a visual analog scale numbered 0-10 with visual descriptors. For example, at 0 the descriptor is "very poorly recovered/extremely tired" and at 10 the descriptor is "very well recovered/highly energetic".	Prior to every resistance training session throughout the study.
Secondary	Immunoglobulin A (IgA)	Experimental outcome examining the concentration of IgA in fasted saliva samples.	Pre, Week 2, Week 5, Week 6
Secondary	Cortisol	Experimental outcome examining the concentration of Cortisol in fasted saliva samples.	Pre, Week 2, Week 5, Week 6
Secondary	Testosterone	Experimental outcome examining the concentration of testosterone in fasted saliva samples.	Pre, Week 2, Week 5, Week 6
Secondary	Complete Blood Count	Complete blood count with differential will be assessed via fasted whole blood samples.	Pre and Week 6
Secondary	Comprehensive Metabolic Panel	Comprehensive metabolic panel will be assessed via fasted whole blood samples.	Pre and Week 6
Secondary	Urinalysis	Urinalysis gross examinations will be conducted prior to and at the completion of the study (Week 6).	Pre and Week 6.