Oxidative StressNCT04315077
The Short Term Effects of Oceanix Supplementation on Recovery
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
The purpose of this study will be to examine the effects of Oceanix supplementation on isometric mid-thigh pull force kinetics and salivary immunoglobulin A (indice of immune function) following a one-week intense resistance training protocol. 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
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 25 Nov 2019
- 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
- At least 1 year of consistent resistance training experience (i.e. three days per week).
- Physically active males and females aged 18 to 45 years old.
Who cannot join
- Having a BMI of 30 or more kg/m²
- Having cardiovascular, metabolic, or endocrine disease.
- Undergone surgery that affects digestion and absorption.
- Smoker or use of smokeless tobacco
- 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.
- Fish, shellfish, algae, or seaweed allergy.
- Any history of anabolic-androgenic steroid use.
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 Effects of Short Term Oceanix Supplementation on Muscle Mass, Strength, and Power Underneath Extreme Training Conditions in Healthy and Elite Athletic Populations
The purpose of this study will be to examine the effects of Oceanix supplementation on isometric mid-thigh pull force kinetics and salivary immunoglobulin A (indice of immune function) following a one-week intense resistance training protocol. The study will be carried out in a randomized, double-blind, placebo-controlled, parallel manner. Subjects will be stratified into quartiles based on peak force achieved in the isometric mid-thigh pull assessment during screen and prior to baseline testing. Subjects from each quartile will be randomly divided by into treatment and or placebo conditions.
Following randomization, subjects will be baseline tested on isometric mid-thigh pull and salivary immunoglobulin A. Following baseline testing, subject will be given their respective supplement conditions and will be instructed to consume one serving (25mg) a day for 21 consecutive days. For days 1 through 14 subjects will be asked to refrain from resistance training. Subjects will undergo a five day intense resistance training protocol will on day 15 to day 19. Subjects will complete follow-up testing in a manner identical to baseline on day 20 and 21 (24- and 48-hours post completion of the training protocol).
Read the detailed description
The purpose of this study will be to examine the effects of Oceanix supplementation on isometric mid-thigh pull force kinetics and salivary immunoglobulin A (indice of immune function) following a one-week intense resistance training protocol. The study will be carried out in a randomized, double-blind, placebo-controlled, parallel manner. Subjects will be stratified into quartiles based on peak force achieved in the isometric mid-thigh pull assessment during screen and prior to baseline testing. Subjects from each quartile will be randomly divided by into treatment and or placebo conditions. Supplement conditions will be provided in visually identical capsules and containers. Supplement compliance will be determined via supplement logs and collection of supplement containers on day 21. Subjects will be instructed to refrain from consuming other nutritional supplements for the duration of the study.
Following randomization, subjects will be baseline tested on isometric mid-thigh pull and salivary immunoglobulin A. Following baseline testing, subject will be given their respective supplement conditions and will be instructed to consume one serving (25mg) a day for 21 consecutive days. For days 1 through 14 subjects will be instructed to consume their condition with their first meal of the day, and they will asked to refrain from resistance training during this time frame. Subjects will undergo a five day intense resistance training protocol will on day 15 to day 19, and they will be instructed to consume their condition approximately 30 minutes prior to the training session. Subjects will complete follow-up testing in a manner identical to baseline on day 20 and 21 (24- and 48-hours post completion of the training protocol) consuming their condition approximately 30 minutes prior to their arrival at the laboratory.
The five day resistance training protocol will consist of two lower-, two upper-, and one full-body workout. Exercise sets performed on the first four days of the protocol will be targeted will repetition maximum loads such that sets will be perform to or near muscular failure. On the fifth day of the protocol, subjects will perform sets of bodyweight rear foot elevated split squats to failure for a total of 10 sets (5 sets with each leg in an alternating fashion). Subjects will be instructed to maintain the cadence set on an audible metronome, which will be set at one second downward and one second upward. Failure for these sets will be defined as 1) volitional muscle failure or 2) failure to complete two consecutive repetitions at the prescribed metronome cadence. Subjects will rest for one minute between sets. Prior to all training sessions, subjects will perform a dynamic warm-up, and following all training sessions, subjects will complete a cool down with static stretching of the targeted muscle groups with the session. All warm-up, resistance training, and cool down sessions will be supervised by trained research personnel. All training sessions will be separated by at least 24-hours.
- Being tested
- Oceanix®, Resistance Training
- Keywords
- Oxidative Stress, Muscle Strength, Antioxidants, Resistance Training, Immune Function, Exercise Recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oceanix®Dietary supplement
Ingredient contains highly active antioxidant enzymes, including superoxide dismutase (SOD), as well as essential fatty acids, vitamins, amino acids and minerals.
Resistance TrainingOther
5 days of supervised and programmed whole-body resistance training.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Subjects will consume one serving per day (25mg) of the treatment condition (Oceanix ®) for 21 days following baseline testing. Days 1 through 14 subjects will consume the supplement with the first meal of the day and refrain from resistance training. Days 15 through 19, subjects will complete one supervised resistance training each day and consume the supplement approximately 30 minutes prior to the training session. On days 20 and 21, subjects will complete follow-up testing in a manner identical to baseline and consume the supplement approximately 30 minutes prior to their arrival at the laboratory. Receives: Dietary Supplement: Oceanix®; Other: Resistance Training |
| Placebo Group | Placebo comparator | Subjects will consume one serving per day (25mg) of the microcrystalline cellulose-based placebo condition for 21 days following baseline testing. Days 1 through 14 subjects will consume the supplement with the first meal of the day and refrain from resistance training. Days 15 through 19, subjects will complete one supervised resistance training each day and consume the supplement approximately 30 minutes prior to the training session. On days 20 and 21, subjects will complete follow-up testing in a manner identical to baseline and consume the supplement approximately 30 minutes prior to their arrival at the laboratory. Receives: Other: Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Muscle Strength (Forces exerted in kg)
Assessed by Isometric Mid-Thigh Pull.
Measured: Baseline, 24-Hours Post Last Training Day, 48-Hours Post Last Training Day
Changes in Rate of Force Development (Newtons per second)
Assessed by Isometric Mid-Thigh Pull
Measured: Baseline, 24-Hours Post Last Training Day, 48-Hours Post Last Training Day
Secondary outcomes (1)
Immunoglobulin A (micrograms per milliliter)
Experimental outcome examining the concentration of immunoglobulin A in fasted saliva sample.
Measured: Baseline, 24-Hours Post Last Training Day, 48-Hours Post Last Training Day
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 start1 Oct 2019
- Primary completion23 Nov 2019
- Study completion25 Nov 2019
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
- 22 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
- NCT04315077
- Sponsor's protocol ID
- 0519
- Status last verified
- Nov 2020
- First submitted
- 11 Mar 2020
- Last updated
- 19 Nov 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 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Short Term Oceanix Supplementation on Muscle Mass, Strength, and Power Underneath Extreme Training Conditions in Healthy and Elite Athletic Populations
- ClinicalTrials.gov ID
- NCT04315077
- Acronym / sponsor ID
- 0519
- Keywords
- Oxidative Stress, Muscle Strength, Antioxidants, Resistance Training, Immune Function, Exercise Recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Applied Science & Performance InstituteIndustry (pharma, biotech, devices)
- Collaborators
- Lonza Ltd.
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 23 Nov 2019 (actual)
- Study completion
- 25 Nov 2019 (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.
The purpose of this study will be to examine the effects of Oceanix supplementation on isometric mid-thigh pull force kinetics and salivary immunoglobulin A (indice of immune function) following a one-week intense resistance training protocol. The study will be carried out in a randomized, double-blind, placebo-controlled, parallel manner. Subjects will be stratified into quartiles based on peak force achieved in the isometric mid-thigh pull assessment during screen and prior to baseline testing. Subjects from each quartile will be randomly divided by into treatment and or placebo conditions.
Following randomization, subjects will be baseline tested on isometric mid-thigh pull and salivary immunoglobulin A. Following baseline testing, subject will be given their respective supplement conditions and will be instructed to consume one serving (25mg) a day for 21 consecutive days. For days 1 through 14 subjects will be asked to refrain from resistance training. Subjects will undergo a five day intense resistance training protocol will on day 15 to day 19. Subjects will complete follow-up testing in a manner identical to baseline on day 20 and 21 (24- and 48-hours post completion of the training protocol).
Detailed description
The purpose of this study will be to examine the effects of Oceanix supplementation on isometric mid-thigh pull force kinetics and salivary immunoglobulin A (indice of immune function) following a one-week intense resistance training protocol. The study will be carried out in a randomized, double-blind, placebo-controlled, parallel manner. Subjects will be stratified into quartiles based on peak force achieved in the isometric mid-thigh pull assessment during screen and prior to baseline testing. Subjects from each quartile will be randomly divided by into treatment and or placebo conditions. Supplement conditions will be provided in visually identical capsules and containers. Supplement compliance will be determined via supplement logs and collection of supplement containers on day 21. Subjects will be instructed to refrain from consuming other nutritional supplements for the duration of the study.
Following randomization, subjects will be baseline tested on isometric mid-thigh pull and salivary immunoglobulin A. Following baseline testing, subject will be given their respective supplement conditions and will be instructed to consume one serving (25mg) a day for 21 consecutive days. For days 1 through 14 subjects will be instructed to consume their condition with their first meal of the day, and they will asked to refrain from resistance training during this time frame. Subjects will undergo a five day intense resistance training protocol will on day 15 to day 19, and they will be instructed to consume their condition approximately 30 minutes prior to the training session. Subjects will complete follow-up testing in a manner identical to baseline on day 20 and 21 (24- and 48-hours post completion of the training protocol) consuming their condition approximately 30 minutes prior to their arrival at the laboratory.
The five day resistance training protocol will consist of two lower-, two upper-, and one full-body workout. Exercise sets performed on the first four days of the protocol will be targeted will repetition maximum loads such that sets will be perform to or near muscular failure. On the fifth day of the protocol, subjects will perform sets of bodyweight rear foot elevated split squats to failure for a total of 10 sets (5 sets with each leg in an alternating fashion). Subjects will be instructed to maintain the cadence set on an audible metronome, which will be set at one second downward and one second upward. Failure for these sets will be defined as 1) volitional muscle failure or 2) failure to complete two consecutive repetitions at the prescribed metronome cadence. Subjects will rest for one minute between sets. Prior to all training sessions, subjects will perform a dynamic warm-up, and following all training sessions, subjects will complete a cool down with static stretching of the targeted muscle groups with the session. All warm-up, resistance training, and cool down sessions will be supervised by trained research personnel. All training sessions will be separated by at least 24-hours.
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 |
|---|---|---|
| Experimental Group | Experimental | Dietary Supplement: Oceanix®, Other: Resistance TrainingSubjects will consume one serving per day (25mg) of the treatment condition (Oceanix ®) for 21 days following baseline testing. Days 1 through 14 subjects will consume the supplement with the first meal of the day and refrain from resistance training. Days 15 through 19, subjects will complete one supervised resistance training each day and consume the supplement approximately 30 minutes prior to the training session. On days 20 and 21, subjects will complete follow-up testing in a manner identical to baseline and consume the supplement approximately 30 minutes prior to their arrival at the laboratory. |
| Placebo Group | Placebo comparator | Other: Resistance TrainingSubjects will consume one serving per day (25mg) of the microcrystalline cellulose-based placebo condition for 21 days following baseline testing. Days 1 through 14 subjects will consume the supplement with the first meal of the day and refrain from resistance training. Days 15 through 19, subjects will complete one supervised resistance training each day and consume the supplement approximately 30 minutes prior to the training session. On days 20 and 21, subjects will complete follow-up testing in a manner identical to baseline and consume the supplement approximately 30 minutes prior to their arrival at the laboratory. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- At least 1 year of consistent resistance training experience (i.e. three days per week).
- Physically active males and females aged 18 to 45 years old.
Key exclusion criteria (10 listed)
- Having a BMI of 30 or more kg/m²
- Having cardiovascular, metabolic, or endocrine disease.
- Undergone surgery that affects digestion and absorption.
- Smoker or use of smokeless tobacco
- 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 |
|---|---|---|
| Oceanix®Ingredient contains highly active antioxidant enzymes, including superoxide dismutase (SOD), as well as essential fatty acids, vitamins, amino acids and minerals. | Dietary supplement | Experimental Group |
| Resistance Training5 days of supervised and programmed whole-body resistance training. | Other | Experimental Group, Placebo Group |
Primary outcome
Changes in Muscle Strength (Forces exerted in kg)
Time frame: Baseline, 24-Hours Post Last Training Day, 48-Hours Post Last Training Day
Assessed by Isometric Mid-Thigh Pull.
Changes in Rate of Force Development (Newtons per second)
Time frame: Baseline, 24-Hours Post Last Training Day, 48-Hours Post Last Training Day
Assessed by Isometric Mid-Thigh Pull
1 secondary outcome
Immunoglobulin A (micrograms per milliliter)
Time frame: Baseline, 24-Hours Post Last Training Day, 48-Hours Post Last Training Day
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 Nov 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 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 19 Nov 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 (Forces exerted in kg) (time frame: Baseline, 24-Hours Post Last Training Day, 48-Hours Post Last Training Day). The study lists 2 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 Nov 2020.