Status:
COMPLETED
Inflammatory and Immune Response After High Intensity Exercise
Lead Sponsor:
Marinova Pty Ltd
Collaborating Sponsors:
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
University of South Carolina
Conditions:
Inflammatory Response
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief 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 int...
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, a...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
January 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT05277727
Start Date
January 5 2022
End Date
June 30 2022
Last Update
July 12 2022
Active Locations (1)
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1
University of South Carolina Sport Science Lab
Columbia, South Carolina, United States, 29208