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| Name | Class |
|---|---|
| Nutrasource Pharmaceutical and Nutraceutical Services, Inc. | NETWORK |
| University of South Carolina | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fucoidan | Experimental | Fucoidan in Capsule Intervention: Dietary Supplement: Probiotic |
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| Placebo | Placebo Comparator | Non active ingredients in a capsule Intervention: Other: Placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fucoidan 500mg | Dietary Supplement | 1 capsule to be taken twice daily with food (morning and evening). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | After 14 days of supplementation |
| Changes in interleukin-6 | To determine if the TP has an impact on interleukin-6 compared to placebo | After 14 days of supplementation |
| Changes in interleukin-1B | To determine if the TP has an impact on interleukin-1B compared to placebo | After 14 days of supplementation |
| Changes in interleukin-10 | To determine if the TP has an impact on interleukin-10 compared to placebo | After 14 days of supplementation |
| Changes in T cell | Monitor changes in T cell subset CD4 and CD8 for TP compared to placebo | After 14 days of supplementation |
| Changes in B cell | Monitor changes in B cell subset CD4 and CD8 for TP compared to placebo | After 14 days of supplementation |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Outcome Measures | Adverse events monitoring during the course of study to compare the safety of the TP compared to placebo. | After 14 days of supplementation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bridget McFadden | Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Carolina Sport Science Lab | Columbia | South Carolina | 29208 | United States |
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| ID | Term |
|---|---|
| C007789 | fucoidan |
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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.
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Both subjects and study research team will not be aware of their assigned conditions.
| Placebo | Dietary Supplement | 1 capsule to be taken twice daily with food (morning and evening). |
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