Oxidative StressNCT04314596
The Effects of Antioxidant Supplementation on Multiple Endurance Race Performance, Physiology, and Recovery.
A study testing Cross Training Course and Oceanix in people with Oxidative Stress and Muscle Strength, run by Applied Science & Performance Institute at 1 site in United States.
Trial summary
Thirty active male and female athletes will be recruited for the study. Subjects will be examined at baseline for VO2max performance. Subjects will then be stratified and randomly divided equally (50% - 50%) into an Oceanix (supplemental) or placebo condition such that baseline VO2max match. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress, Muscle Strength, Resistance Training
- What is being tested?
- Cross Training Course and Oceanix
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2020to 19 Feb 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
- Males and females age 18 to 45 years old
- At least one year of cross training experience (i.e. 3 days/week)
Who cannot join
- BMI of 30 or more kg/m²
- Any allergies to fish, shellfish, algae, or seaweed are excluded from participation
- Have any cardiovascular, metabolic, or endocrine disease
- Undergone surgery that affects digestion and absorption
- Smoking
- Drink heavily (> 7 and > 14 drinks per week for women and men, respectively)
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Applied Science & Performance Institute
Tampa, Florida, 33607
About this study
Thirty active male and female athletes will be recruited for the study. Subjects will be examined at baseline for VO2max performance. Subjects will then be stratified and randomly divided equally (50% - 50%) into an Oceanix (supplemental) or placebo condition such that baseline VO2max match. Once randomization, subjects will be baseline tested for multiple measures of muscle force capacity, muscle soreness, immune function, and endocrine function. Upon completion of baseline testing, subjects will all complete a one-day, cross-training course in Tampa, Florida. The training course is known to be extremely vigorous and causes significant muscle damage. Subjects will then be retested for muscle function at 24, and 48 hours following the course. At 24- and 48-hours subjects will be asked to repeat a simulated time trial race. In this way, we will measure repeated race performance, recovery from intense exercise, muscle damage from exercise, and immune function during multiple races.
- Being tested
- Cross Training Course, Oceanix
- 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.
Cross Training CourseOther
One day of a supervised, whole body, cross-training course that is meant to produce muscle damage and soreness.
OceanixDietary supplement
Ingredient contains highly active antioxidant enzymes, including superoxide dismutase (SOD), as well as essential fatty acids, vitamins, amino acids and minerals.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group | Placebo comparator | Participants will engage in a one day, whole-body, cross-training course while 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. Participants will then come in 24 and 48 hours post, cross-training course to be tested. Receives: Other: Cross Training Course |
| Experimental Group | Experimental | Participants will engage in a one day, whole-body, cross-training course while consuming the treatment condition (Oceanix™) 30 minutes prior to exercise on training days or with the first meal of the day on non-training days. Participants will then come in 24 and 48 hours post, cross-training course to be tested. Receives: Other: Cross Training Course; Dietary Supplement: Oceanix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in muscle strength
Assessed by isometric mid-thigh pull.
Measured: Baseline, 24-Hour Post Cross-Training Course, 48-Hours Post Cross-Training Course.
Changes in muscle power
Assessed through ground reaction forces during countermovement and squat jumps on a force plate.
Measured: Baseline, 24-Hour Post Cross-Training Course, 48-Hours Post Cross-Training Course.
Changes in One(1) Mile Timed Run
Experimental outcome assessing how quickly a 1 mile run can be completed.
Measured: Baseline, 24-Hour Post Cross-Training Course, 48-Hours Post Cross-Training Course.
Changes in Perceived Recovery Status (PRS)
Assessed through a visual analog scale (modified Borg Scale) numbered 0 to 10 with visual descriptors.
Measured: Baseline, 1 Day of Cross-Training Course, 24-Hour Post Cross-Training Course, 48-Hours Post Cross-Training Course.
Changes in Rating of Perceived Exertion (RPE)
Assessed through a visual analog scale numbered 0 to 10 with visual descriptors.
Measured: Baseline, 1 Day of Cross-Training Course, 24-Hour Post Cross-Training Course, 48-Hours Post Cross-Training Course.
Changes in Perceived Soreness Scale
Assessed through a visual analog scale numbered 0 to 10 with visual descriptors.
Measured: Baseline, 1 Day of Cross-Training Course, 24-Hour Post Cross-Training Course, 48-Hours Post Cross-Training Course.
Secondary outcomes (2)
Creatine Kinase
Experimental outcome examining creatine kinase in fasted whole blood samples. This is biomarker an indirect measure of muscle damage.
Measured: Baseline, 24-Hour Post Cross-Training Course, 48-Hours Post Cross-Training Course.
Cortisol
Experimental outcome examining the concentration of cortisol in fasted saliva samples.
Measured: Baseline, 24-Hour Post Cross-Training Course, 48-Hours Post Cross-Training Course.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start20 Jan 2020
- Primary completion12 Feb 2020
- Study completion19 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Applied Science & Performance Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lonza Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04314596
- Sponsor's protocol ID
- 1219
- Status last verified
- Mar 2020
- First submitted
- 17 Mar 2020
- Last updated
- 19 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No