Clinical trial NCT04136821: The Long-term Effects of Oceanix™ on Resistance Training Adaptations
Official title: The Long-term Effects of Oceanix™ Supplementation on Oxidative Stress, Performance, Body Composition and Safety Metrics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxidative Stress
Muscle Strength
Resistance Training
Body Composition
Muscle Damage
Keywords: Oxidative Stress
Muscle Strength
Resistance Training
Antioxidants
Lead sponsor: Applied Science & Performance Institute
Sponsor class: INDUSTRY
Collaborators: name: Lonza Ltd.
First posted: 2019-10-23
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind, parallel, randomized, placebo-controlled trial
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: 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

Primary outcomes:
measure: Changes in muscle strength
timeFrame: Pre, Week 2, Week 5, Week 6
measure: Changes in muscle power
timeFrame: Pre, Week 2, Week 5, Week 6
measure: Total Antioxidant Capacity (TAC)
timeFrame: Pre, Week 2, Week 5, Week 6
measure: Superoxide Dimutase (SOD)
timeFrame: Pre, Week 2, Week 5, Week 6
measure: Creatine Kinase (CK)
timeFrame: Pre, Week 2, Week 5, Week 6
measure: Body Composition
timeFrame: Pre and Week 6
Secondary outcomes:
measure: Rating of Perceived Exertion (RPE)
timeFrame: Following every resistance training session throughout the study.
measure: Perceived Recovery Status (PRS)
timeFrame: Prior to every resistance training session throughout the study.
measure: Immunoglobulin A (IgA)
timeFrame: Pre, Week 2, Week 5, Week 6
measure: Cortisol
timeFrame: Pre, Week 2, Week 5, Week 6
measure: Testosterone
timeFrame: Pre, Week 2, Week 5, Week 6
measure: Complete Blood Count
timeFrame: Pre and Week 6
measure: Comprehensive Metabolic Panel
timeFrame: Pre and Week 6
measure: Urinalysis
timeFrame: Pre and Week 6.
Other outcomes:
measure: Resting Systolic Blood Pressure
timeFrame: Pre and Week 6
measure: Resting Diastolic Blood Pressure
timeFrame: Pre and Week 6
Locations:
city: Tampa
country: United States
facility: Applied Science & Performance Institute
state: Florida
Study officials:
References: