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Oxidative StressNCT04136821

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

A study testing Oceanix and Resistance Training in people with Oxidative Stress and Muscle Strength, run by Applied Science & Performance Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
What is being tested?
Oceanix and Resistance Training
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
25 participants
Where
1 siteUnited States
Study dates
30 Sep 2019to 31 Jan 2020
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • > 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
Show all 10Show fewer
  • 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 locations and contacts

1 site in 1 country.

United States1 site
  • Applied Science & Performance Institute

    Tampa, Florida, 33607

Other trials in United States

About this study

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.

Read the 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
Being tested
Oceanix, Resistance Training
Keywords
Oxidative Stress, Muscle Strength, Resistance Training, Antioxidants

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OceanixDietary supplement

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

  • Resistance TrainingOther

    6 weeks of supervised and programmed whole body resistance training, performed 3-5 times per week.

Study groups in NCT04136821
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants 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.
Receives: Other: Resistance Training
Oceanix™ExperimentalParticipants 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.
Receives: Dietary Supplement: Oceanix; Other: Resistance Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in muscle strength

    Assessed by isometric mid-thigh pull and isometric bench-press

    Measured: Pre, Week 2, Week 5, Week 6

  2. Changes in muscle power

    Assessed through ground reaction forces during countermovement- and squat-jumps on a force plate.

    Measured: Pre, Week 2, Week 5, Week 6

  3. 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.

    Measured: Pre, Week 2, Week 5, Week 6

  4. Superoxide Dimutase (SOD)

    Experimental outcome examining superoxide dimutase in fasted whole blood samples. This is another protective antioxidant enzyme measured from whole blood.

    Measured: Pre, Week 2, Week 5, Week 6

  5. Creatine Kinase (CK)

    Experimental outcome examining creatine kinase in fasted whole blood samples. This is biomarker an indirect measure of muscle damage.

    Measured: Pre, Week 2, Week 5, Week 6

  6. 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.

    Measured: Pre and Week 6

Secondary outcomes (8)
  1. 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".

    Measured: Following every resistance training session throughout the study.

  2. 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".

    Measured: Prior to every resistance training session throughout the study.

  3. Immunoglobulin A (IgA)

    Experimental outcome examining the concentration of IgA in fasted saliva samples.

    Measured: Pre, Week 2, Week 5, Week 6

  4. Cortisol

    Experimental outcome examining the concentration of Cortisol in fasted saliva samples.

    Measured: Pre, Week 2, Week 5, Week 6

  5. Testosterone

    Experimental outcome examining the concentration of testosterone in fasted saliva samples.

    Measured: Pre, Week 2, Week 5, Week 6

  6. Complete Blood Count

    Complete blood count with differential will be assessed via fasted whole blood samples.

    Measured: Pre and Week 6

  7. Comprehensive Metabolic Panel

    Comprehensive metabolic panel will be assessed via fasted whole blood samples.

    Measured: Pre and Week 6

  8. Urinalysis

    Urinalysis gross examinations will be conducted prior to and at the completion of the study (Week 6).

    Measured: Pre and Week 6.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2019
  2. Study start30 Sep 2019
  3. Primary completion15 Nov 2019
  4. Study completion31 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Double-blind, parallel, randomized, placebo-controlled trial
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04136821
Sponsor's protocol ID
ASPI0519
Status last verified
Feb 2020
First submitted
16 Oct 2019
Last updated
27 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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