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CompletedNCT05277727Updated Jul 12, 2022

Inflammatory and Immune Response After High Intensity Exercise

An interventional study of Fucoidan 500mg and Placebo in Inflammatory Response, sponsored by Marinova Pty Ltd. Completed at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-12.

Sponsored by Marinova Pty Ltd · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Inflammatory Response
03

In context

Lead sponsor

This is the only study on the registry with Marinova Pty Ltd as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Fully vaccinated against COVID-19 (participant has received their final dose at least one month prior to the screening visit).
  2. 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.
  3. Healthy individuals between 18 to 40 years of age (inclusive).
  4. Individuals with BMI in the range of 18.5-34.9 (inclusive).
  5. Good health as determined by medical history and cleared for exercise as assessed by the PI.
  6. 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.
  7. Provide signed and dated informed consent form.
  8. Willing and able to comply with the protocol.

Exclusion criteria

Exclusion Criteria:

  1. Participants with existing musculoskeletal injuries that would prevent full participation.
  2. 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.
  3. Females who are pregnant, lactating, or planning on becoming pregnant during the course of the study.
  4. Participants using blood thinning medications or supplements.
  5. Participants having a known sensitivity or allergy to any of the study products or their excipients.
  6. 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.
  7. Participants with current or past medical history of long-term COVID-19 symptoms (remained symptomatic for at least 2 weeks or more).
  8. Professional athletes, collegiate athletes, competitive body builders, or those who compete at the elite category within their sport.
  9. 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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Fucoidan

    Fucoidan in Capsule Intervention: Dietary Supplement: Probiotic

    Dietary Supplement: Fucoidan 500mg

  • Placebo comparator
    Placebo

    Non active ingredients in a capsule Intervention: Other: Placebo

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementFucoidan 500mg

    1 capsule to be taken twice daily with food (morning and evening).

  • Dietary supplementPlacebo

    1 capsule to be taken twice daily with food (morning and evening).

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: After 14 days of supplementation

  2. Changes in interleukin-6

    To determine if the TP has an impact on interleukin-6 compared to placebo

    Time frame: After 14 days of supplementation

  3. Changes in interleukin-1B

    To determine if the TP has an impact on interleukin-1B compared to placebo

    Time frame: After 14 days of supplementation

  4. Changes in interleukin-10

    To determine if the TP has an impact on interleukin-10 compared to placebo

    Time frame: After 14 days of supplementation

  5. Changes in T cell

    Monitor changes in T cell subset CD4 and CD8 for TP compared to placebo

    Time frame: After 14 days of supplementation

  6. Changes in B cell

    Monitor changes in B cell subset CD4 and CD8 for TP compared to placebo

    Time frame: 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.

    Time frame: After 14 days of supplementation

07

Study locations

1 site
  • University of South Carolina Sport Science Lab
    Columbia, South Carolina 29208, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05277727
Lead sponsor
Marinova Pty Ltd
Collaborators
Nutrasource Pharmaceutical and Nutraceutical Services, Inc., University of South Carolina
Responsible party
Sponsor
First posted
Mar 14, 2022
Start date
Jan 5, 2022
Primary completion
Mar 4, 2022
Completion
Jun 30, 2022
Last update
Jul 12, 2022

Study contacts

Bridget McFadden
principal investigator · Principal Investigator

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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