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
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.
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.
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.
Exclusion Criteria:
Fucoidan in Capsule Intervention: Dietary Supplement: Probiotic
Dietary Supplement: Fucoidan 500mg
Non active ingredients in a capsule Intervention: Other: Placebo
Dietary Supplement: Placebo
1 capsule to be taken twice daily with food (morning and evening).
1 capsule to be taken twice daily with food (morning and evening).
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
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
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
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
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
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
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
Plan to share: No
No publications or documents are linked to this record.
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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