Marine Algae Supplement and the Effects on Post Exercise Inflammatory Response

Safety Issues Clinical Trial

Official title:

Impact of a Novel Marine Algae Supplement on the Inflammatory and Immune Response After High Intensity Exercise

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05181410
• Other study ID #: Pro00114427
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 5, 2022
• Est. completion date: June 2022

Study information

• Verified date: March 2022
• Source: University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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. Acute exercise has been shown to increase inflammation. The immune system response depends on intensity of the exercise as well as the duration of rest between exercise sessions. 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 results 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. Supplementation with Fucoidans may play a role in immune modulation as well as inflammation.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16
• Est. completion date: June 2022
• Est. primary completion date: March 4, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Fully vaccinated against COVID-19 (participant has received his/her final dose at least one month prior to the screening visit).

2. Individuals who regularly exercise as per physical activity guidelines for Americans10 [(structured or unstructured 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. Males and females of reproductive potential 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:

1. Participants with existing musculoskeletal injuries that would prevent full participation, or a history of autoimmune disease or diabetes.

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 investigator, may preclude safe study participation.

3. Females who are pregnant or lactating or planning on becoming pregnant during the course of the study.

4. Participants using blood thinning medications or supplements.

5. Have a known sensitivity or allergy to any of the study products or its excipients.

6. Participants who develop a cold or other acute upper respiratory tract infections or influenza or any other major illness during the course of study which may compromise participants ability to complete study procedures or affect study outcomes.

7. Participating or has participated in another research study within 30 days prior to the study screening visit in which another study product has been consumed.

8. Participants with current or past medical history of long-term COVID-19 symptoms (remained symptomatic for at least 2 weeks or more).

9. Professional athletes, collegiate athletes, competitive body builders or those who compete at the elite category within their sport.

10. 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.

Related Conditions & MeSH terms

• Effect of Drug
• Safety Issues

Intervention

Dietary Supplement:
• Marine Alage
Participants will be randomized to FMAS (2 weeks) ? washout (1 week) ? placebo.

Other:
• Placebo
Participants will be randomized to IPC (2 weeks) ? washout (1 week) ? FMAS (2 weeks).

Locations

Country	Name	City	State
United States	University of South Carolina Sport Science Lab	Columbia	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in CBC panel	CBC panel with differential compared between two study arms to determine if the TP has an impact compared to placebo	Baseline, Visit 3, and Visit 5
Primary	Changes in interleukin-6	To determine if the TP has an impact on interleukin-6 compared to placebo	Baseline, Visit 3, and Visit 5
Primary	Changes in interleukin-10	To determine if the TP has an impact on interleukin-10 compared to placebo	Baseline, Visit 3, and Visit 5
Primary	Changes in interleukin-1B	To determine if the TP has an impact on interleukin-10 compared to placebo	Baseline, Visit 3, and Visit 5
Primary	Safety/ Adverse Events	Adverse events monitoring during the course of study to compare the safety of the TP compared to placebo.	Baseline, Visit 3, and Visit 5
Primary	Changes in T cell	Monitor changes in T cell subset CD4 and CD8 for TP compared to placebo	Baseline, Visit 3, and Visit 5
Primary	Changes in B cell	Monitor changes in B cell subset CD4 and CD8 for TP compared to placebo	Baseline, Visit 3, and Visit 5