Inflammatory ResponseNCT05277727
Inflammatory and Immune Response After High Intensity Exercise
A study testing Fucoidan 500mg in people with Inflammatory Response, run by Marinova Pty Ltd at 1 site in United States.
Trial summary
This double-blinded, randomized, placebo-controlled, cross-over study is designed to evaluate the potential effects of a fucoidan supplement on the inflammatory and immune responses following high intensity exercise. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Response
- What is being tested?
- Fucoidan 500mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2022to 30 Jun 2022
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Fully vaccinated against COVID-19 (participant has received their final dose at least one month prior to the screening visit).
- Individuals who regularly exercise as per physical activity guidelines for Americans10 [structured exercise for a minimum of 150 cumulative minutes per week (low end) to 500 cumulative minutes of exercise per week (high-end)] and willing to maintain the same level of physical activity throughout the study period.
- Healthy individuals between 18 to 40 years of age (inclusive).
- Individuals with BMI in the range of 18.5-34.9 (inclusive).
- Good health as determined by medical history and cleared for exercise as assessed by the PI.
- Male and female participants of reproductive potential should be willing to use double-barrier to avoid pregnancy and sexually transmitted infection (STI) during the study period.
- Provide signed and dated informed consent form.
- Willing and able to comply with the protocol.
Who cannot join
- Participants with existing musculoskeletal injuries that would prevent full participation.
- History of clinically significant cardiovascular, respiratory, renal, cerebrovascular, metabolic, pulmonary, gastrointestinal, neurological, hematological, autoimmune, lymphatic, psychiatric, hepatobiliary, or endocrine disorders, including individuals with Type I or Type II diabetes, or other clinically significant medical condition that, in the opinion of the PI, may preclude safe study participation.
- Females who are pregnant, lactating, or planning on becoming pregnant during the course of the study.
- Participants using blood thinning medications or supplements.
- Participants having a known sensitivity or allergy to any of the study products or their excipients.
- Participating or has participated in another research study in which another study product has been consumed within 30 days prior to the study screening visit.
Show all 9Show fewer
- Participants with current or past medical history of long-term COVID-19 symptoms (remained symptomatic for at least 2 weeks or more).
- Professional athletes, collegiate athletes, competitive body builders, or those who compete at the elite category within their sport.
- Participant having any condition or abnormality that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the study data.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina Sport Science Lab
Columbia, South Carolina, 29208
About this study
Official title: Impact of a Novel Marine Algae Supplement on the Inflammatory and Immune Response After High Intensity Exercise
This double-blinded, randomized, placebo-controlled, cross-over study is designed to evaluate the potential effects of a fucoidan supplement on the inflammatory and immune responses following high intensity exercise.
Read the detailed description
Inflammation is an innate immune response to tissue damage as a means of increasing blood flow to a specific area to facilitate repair, and is associated with the movement of fluid, plasma proteins, and immune cells from the circulation to the site of injury. The inflammatory process is initiated by cytokines which attract specific immune cells, such as monocytes, lymphocytes, neutrophils, and eosinophils, to the damaged tissue. Chronic exercise has been found to reduce inflammation and bolster immune system function; however, acute exercise has been shown to increase inflammatory response. Cytokine secretion and concentrations as well as leukocyte activation following exercise appear to increase in proportion to exercise intensity. Therefore, on an acute basis, high intensity exercise may cause immunosuppression and increased inflammation. High degrees of muscle damage and inflammation post-exercise result in decrements in muscle strength and range of motion, increased delayed onset muscle soreness (DOMS) and swelling, as well as the efflux of myocellular proteins and enzymes, including creatine kinase (CK). Therefore, post-exercise nutritional supplementation for individuals participating in high intensity exercise may be beneficial to modulate exercise-associated immune function and reduce inflammation.
Fucoidans are fucose-rich sulfated carbohydrates found in brown marine algae and have been shown to play a role in immune modulation as well as inflammation. In fact, fucoidans have been shown to inhibit neutrophil infiltration and attenuate levels of pro-inflammatory cytokines. More research is warranted to determine the effects of supplementation with fucoidans to reduce inflammation following high intensity exercise. Therefore, this double-blinded, randomized, placebo-controlled, cross-over design study will be conducted to further understand these effects.
- Conditions
- Inflammatory Response
- Being tested
- Fucoidan 500mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fucoidan 500mgDietary supplement
1 capsule to be taken twice daily with food (morning and evening).
PlaceboDietary supplement
1 capsule to be taken twice daily with food (morning and evening).
| Study group | Role | What they receive |
|---|---|---|
| Fucoidan | Experimental | Fucoidan in Capsule
Intervention: Dietary Supplement: Probiotic Receives: Dietary Supplement: Fucoidan 500mg |
| Placebo | Placebo comparator | Non active ingredients in a capsule
Intervention: Other: Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in CBC panel
Changes in CBC panel (absolute counts of Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils) compared between two study arms to determine if the TP has an impact compared to placebo
Measured: After 14 days of supplementation
Changes in interleukin-6
To determine if the TP has an impact on interleukin-6 compared to placebo
Measured: After 14 days of supplementation
Changes in interleukin-1B
To determine if the TP has an impact on interleukin-1B compared to placebo
Measured: After 14 days of supplementation
Changes in interleukin-10
To determine if the TP has an impact on interleukin-10 compared to placebo
Measured: After 14 days of supplementation
Changes in T cell
Monitor changes in T cell subset CD4 and CD8 for TP compared to placebo
Measured: After 14 days of supplementation
Changes in B cell
Monitor changes in B cell subset CD4 and CD8 for TP compared to placebo
Measured: After 14 days of supplementation
Secondary outcomes (1)
Safety Outcome Measures
Adverse events monitoring during the course of study to compare the safety of the TP compared to placebo.
Measured: After 14 days of supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start5 Jan 2022
- Primary completion4 Mar 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory ResponseStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a prospective, double-blinded, placebo-controlled, cross-over design study. Participants will be randomized to one of the two SP sequences \[either FMAS (2 weeks) → washout (1 week) → IPC (2 weeks): sequence A, or IPC (2 weeks) → washout (1 week) → FMAS (2 weeks): sequence B\]. Each participant will act as their own control due to the cross-over design of the study.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marinova Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc., University of South Carolina
- Responsible party
- Sponsor
- Investigators
- Bridget McFadden, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05277727
- Sponsor's protocol ID
- M01-21-01-T0011
- Status last verified
- Jul 2022
- First submitted
- 3 Mar 2022
- Last updated
- 12 Jul 2022
- 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 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Novel Marine Algae Supplement on the Inflammatory and Immune Response After High Intensity Exercise
- ClinicalTrials.gov ID
- NCT05277727
- Acronym / sponsor ID
- M01-21-01-T0011
- Conditions
- Inflammatory Response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Marinova Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc., University of South Carolina
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 4 Mar 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 14 Mar 2022 (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 double-blinded, randomized, placebo-controlled, cross-over study is designed to evaluate the potential effects of a fucoidan supplement on the inflammatory and immune responses following high intensity exercise.
Detailed description
Inflammation is an innate immune response to tissue damage as a means of increasing blood flow to a specific area to facilitate repair, and is associated with the movement of fluid, plasma proteins, and immune cells from the circulation to the site of injury. The inflammatory process is initiated by cytokines which attract specific immune cells, such as monocytes, lymphocytes, neutrophils, and eosinophils, to the damaged tissue. Chronic exercise has been found to reduce inflammation and bolster immune system function; however, acute exercise has been shown to increase inflammatory response. Cytokine secretion and concentrations as well as leukocyte activation following exercise appear to increase in proportion to exercise intensity. Therefore, on an acute basis, high intensity exercise may cause immunosuppression and increased inflammation. High degrees of muscle damage and inflammation post-exercise result in decrements in muscle strength and range of motion, increased delayed onset muscle soreness (DOMS) and swelling, as well as the efflux of myocellular proteins and enzymes, including creatine kinase (CK). Therefore, post-exercise nutritional supplementation for individuals participating in high intensity exercise may be beneficial to modulate exercise-associated immune function and reduce inflammation.
Fucoidans are fucose-rich sulfated carbohydrates found in brown marine algae and have been shown to play a role in immune modulation as well as inflammation. In fact, fucoidans have been shown to inhibit neutrophil infiltration and attenuate levels of pro-inflammatory cytokines. More research is warranted to determine the effects of supplementation with fucoidans to reduce inflammation following high intensity exercise. Therefore, this double-blinded, randomized, placebo-controlled, cross-over design study will be conducted to further understand these effects.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective, double-blinded, placebo-controlled, cross-over design study. Participants will be randomized to one of the two SP sequences [either FMAS (2 weeks) → washout (1 week) → IPC (2 weeks): sequence A, or IPC (2 weeks) → washout (1 week) → FMAS (2 weeks): sequence B]. Each participant will act as their own control due to the cross-over design of the study.
| Arm | Type | Receives |
|---|---|---|
| Fucoidan | Experimental | Dietary Supplement: Fucoidan 500mgFucoidan in Capsule Intervention: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboNon active ingredients in a capsule Intervention: Other: Placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Fully vaccinated against COVID-19 (participant has received their final dose at least one month prior to the screening visit).
- Individuals who regularly exercise as per physical activity guidelines for Americans10 [structured exercise for a minimum of 150 cumulative minutes per week (low end) to 500 cumulative minutes of exercise per week (high-end)] and willing to maintain the same level of physical activity throughout the study period.
- Healthy individuals between 18 to 40 years of age (inclusive).
- Individuals with BMI in the range of 18.5-34.9 (inclusive).
- Good health as determined by medical history and cleared for exercise as assessed by the PI.
Key exclusion criteria (9 listed)
- Participants with existing musculoskeletal injuries that would prevent full participation.
- History of clinically significant cardiovascular, respiratory, renal, cerebrovascular, metabolic, pulmonary, gastrointestinal, neurological, hematological, autoimmune, lymphatic, psychiatric, hepatobiliary, or endocrine disorders, including individuals with Type I or Type II diabetes, or other clinically significant medical condition that, in the opinion of the PI, may preclude safe study participation.
- Females who are pregnant, lactating, or planning on becoming pregnant during the course of the study.
- Participants using blood thinning medications or supplements.
- Participants having a known sensitivity or allergy to any of the study products or their excipients.
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 |
|---|---|---|
| Fucoidan 500mg1 capsule to be taken twice daily with food (morning and evening). | Dietary supplement | Fucoidan |
| Placebo1 capsule to be taken twice daily with food (morning and evening). | Dietary supplement | Placebo |
Primary outcome
Changes in CBC panel
Time frame: After 14 days of supplementation
Changes in CBC panel (absolute counts of Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils) compared between two study arms to determine if the TP has an impact compared to placebo
Changes in interleukin-6
Time frame: After 14 days of supplementation
To determine if the TP has an impact on interleukin-6 compared to placebo
Changes in interleukin-1B
Time frame: After 14 days of supplementation
To determine if the TP has an impact on interleukin-1B compared to placebo
Changes in interleukin-10
Time frame: After 14 days of supplementation
To determine if the TP has an impact on interleukin-10 compared to placebo
Changes in T cell
Time frame: After 14 days of supplementation
Monitor changes in T cell subset CD4 and CD8 for TP compared to placebo
Changes in B cell
Time frame: After 14 days of supplementation
Monitor changes in B cell subset CD4 and CD8 for TP compared to placebo
1 secondary outcome
Safety Outcome Measures
Time frame: After 14 days of supplementation
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 12 Jul 2022.
- 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.
Bridget McFadden principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fucoidan 500mg in people with Inflammatory Response, run by Marinova Pty Ltd 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 8 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 12 Jul 2022. 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 CBC panel (time frame: After 14 days of supplementation). 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 12 Jul 2022; AzTrials last refreshed its copy on 29 Oct 2026.