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.
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
- Conditions the study is for
- Oxidative Stress, Muscle Strength, Resistance Training
- 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
- 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
- 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
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 group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 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. Receives: Other: Resistance Training |
| Oceanix™ | Experimental | 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. Receives: Dietary Supplement: Oceanix; Other: Resistance Training |
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 and isometric bench-press
Measured: Pre, Week 2, Week 5, Week 6
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
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
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
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
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)
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.
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.
Immunoglobulin A (IgA)
Experimental outcome examining the concentration of IgA in fasted saliva samples.
Measured: Pre, Week 2, Week 5, Week 6
Cortisol
Experimental outcome examining the concentration of Cortisol in fasted saliva samples.
Measured: Pre, Week 2, Week 5, Week 6
Testosterone
Experimental outcome examining the concentration of testosterone in fasted saliva samples.
Measured: Pre, Week 2, Week 5, Week 6
Complete Blood Count
Complete blood count with differential will be assessed via fasted whole blood samples.
Measured: Pre and Week 6
Comprehensive Metabolic Panel
Comprehensive metabolic panel will be assessed via fasted whole blood samples.
Measured: Pre and Week 6
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.
- First posted23 Oct 2019
- Study start30 Sep 2019
- Primary completion15 Nov 2019
- Study completion31 Jan 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
- 25 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
- 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long-term Effects of Oceanix™ Supplementation on Oxidative Stress, Performance, Body Composition and Safety Metrics
- ClinicalTrials.gov ID
- NCT04136821
- Acronym / sponsor ID
- ASPI0519
- Keywords
- Oxidative Stress, Muscle Strength, Resistance Training, Antioxidants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Applied Science & Performance InstituteIndustry (pharma, biotech, devices)
- Collaborators
- Lonza Ltd.
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 23 Oct 2019 (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.
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
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 | Placebo comparator | Other: Resistance TrainingParticipants 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. |
| Oceanix™ | Experimental | Dietary Supplement: Oceanix, Other: Resistance TrainingParticipants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (10 listed)
- > 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)
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 |
|---|---|---|
| OceanixIngredient contains highly active antioxidant enzymes, including superoxide dismutase (SOD), as well as essential fatty acids, vitamins, amino acids and minerals. | Dietary supplement | Oceanix™ |
| Resistance Training6 weeks of supervised and programmed whole body resistance training, performed 3-5 times per week. | Other | Oceanix™, Placebo |
Primary outcome
Changes in muscle strength
Time frame: Pre, Week 2, Week 5, Week 6
Assessed by isometric mid-thigh pull and isometric bench-press
Changes in muscle power
Time frame: Pre, Week 2, Week 5, Week 6
Assessed through ground reaction forces during countermovement- and squat-jumps on a force plate.
Total Antioxidant Capacity (TAC)
Time frame: Pre, Week 2, Week 5, Week 6
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.
Superoxide Dimutase (SOD)
Time frame: Pre, Week 2, Week 5, Week 6
Experimental outcome examining superoxide dimutase in fasted whole blood samples. This is another protective antioxidant enzyme measured from whole blood.
Creatine Kinase (CK)
Time frame: Pre, Week 2, Week 5, Week 6
Experimental outcome examining creatine kinase in fasted whole blood samples. This is biomarker an indirect measure of muscle damage.
Body Composition
Time frame: Pre and Week 6
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.
8 secondary outcomes
Rating of Perceived Exertion (RPE)
Time frame: Following every resistance training session throughout the study.
Perceived Recovery Status (PRS)
Time frame: Prior to every resistance training session throughout the study.
Immunoglobulin A (IgA)
Time frame: Pre, Week 2, Week 5, Week 6
Cortisol
Time frame: Pre, Week 2, Week 5, Week 6
Testosterone
Time frame: Pre, Week 2, Week 5, Week 6
Complete Blood Count
Time frame: Pre and Week 6
Comprehensive Metabolic Panel
Time frame: Pre and Week 6
Urinalysis
Time frame: Pre and Week 6.
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 27 Feb 2020.
- Individual participant dataSharing planned: No
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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 Oceanix and Resistance Training 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 10 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 27 Feb 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: Pre, Week 2, Week 5, Week 6). 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 27 Feb 2020.