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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Antioxidant Supplementation on Multiple Endurance Race Performance, Physiology, and Recovery.
- ClinicalTrials.gov ID
- NCT04314596
- Acronym / sponsor ID
- 1219
- Keywords
- Oxidative Stress, Muscle Strength, Resistance Training, Antioxidants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Applied Science & Performance InstituteIndustry (pharma, biotech, devices)
- Collaborators
- Lonza Ltd.
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 12 Feb 2020 (actual)
- Study completion
- 19 Feb 2020 (actual)
- First posted
- 19 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-Blind, parallel, randomized, placebo-controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Placebo Group | Placebo comparator | Other: Cross Training CourseParticipants 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. |
| Experimental Group | Experimental | Other: Cross Training Course, Dietary Supplement: OceanixParticipants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Males and females age 18 to 45 years old
- At least one year of cross training experience (i.e. 3 days/week)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cross Training CourseOne day of a supervised, whole body, cross-training course that is meant to produce muscle damage and soreness. | Other | Experimental Group, Placebo Group |
| OceanixIngredient contains highly active antioxidant enzymes, including superoxide dismutase (SOD), as well as essential fatty acids, vitamins, amino acids and minerals. | Dietary supplement | Experimental Group |
Primary outcome
Changes in muscle strength
Time frame: Baseline, 24-Hour Post Cross-Training Course, 48-Hours Post Cross-Training Course.
Assessed by isometric mid-thigh pull.
Changes in muscle power
Time frame: Baseline, 24-Hour Post Cross-Training Course, 48-Hours Post Cross-Training Course.
Assessed through ground reaction forces during countermovement and squat jumps on a force plate.
Changes in One(1) Mile Timed Run
Time frame: Baseline, 24-Hour Post Cross-Training Course, 48-Hours Post Cross-Training Course.
Experimental outcome assessing how quickly a 1 mile run can be completed.
Changes in Perceived Recovery Status (PRS)
Time frame: Baseline, 1 Day of Cross-Training Course, 24-Hour Post Cross-Training Course, 48-Hours Post Cross-Training Course.
Assessed through a visual analog scale (modified Borg Scale) numbered 0 to 10 with visual descriptors.
Changes in Rating of Perceived Exertion (RPE)
Time frame: Baseline, 1 Day of Cross-Training Course, 24-Hour Post Cross-Training Course, 48-Hours Post Cross-Training Course.
Assessed through a visual analog scale numbered 0 to 10 with visual descriptors.
Changes in Perceived Soreness Scale
Time frame: Baseline, 1 Day of Cross-Training Course, 24-Hour Post Cross-Training Course, 48-Hours Post Cross-Training Course.
Assessed through a visual analog scale numbered 0 to 10 with visual descriptors.
2 secondary outcomes
Creatine Kinase
Time frame: Baseline, 24-Hour Post Cross-Training Course, 48-Hours Post Cross-Training Course.
Cortisol
Time frame: Baseline, 24-Hour Post Cross-Training Course, 48-Hours Post Cross-Training Course.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in muscle strength (time frame: Baseline, 24-Hour Post Cross-Training Course, 48-Hours Post Cross-Training Course.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2020.