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

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Applied Science & Performance Institute

Status

Completed

Conditions

Muscle Strength
Muscle Damage
Resistance Training
Oxidative Stress
Body Composition

Treatments

Other: Resistance Training
Dietary Supplement: Oceanix

Study type

Interventional

Funder types

Industry

Identifiers

NCT04136821
ASPI0519

Details and patient eligibility

About

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.

Full 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

Enrollment

25 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

25 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Participants will engage in a 6 week, whole-body, resistance training program 3-5 days per week will consuming a visually identical placebo (25mg hydroxypropyl methylcellulose) 30 minutes prior to exercise on training days or with the first meal of the day on non-training days.
Treatment:
Other: Resistance Training
Oceanix™
Experimental group
Description:
Participants will engage in a 6 week, whole-body, resistance training program 3-5 days per week will consuming a the treatment condition (Oceanix™) 30 minutes prior to exercise on training days or with the first meal of the day on non-training days.
Treatment:
Other: Resistance Training
Dietary Supplement: Oceanix

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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