Clinical trial NCT05277727: Inflammatory and Immune Response After High Intensity Exercise
Official title: Impact of a Novel Marine Algae Supplement on the Inflammatory and Immune Response After High Intensity Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Response
Lead sponsor: Marinova Pty Ltd
Sponsor class: INDUSTRY
Collaborators: name: Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
name: University of South Carolina
First posted: 2022-03-14
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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 intensity exercise.

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.

Eligibility criteria: 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:

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.

Primary outcomes:
measure: Changes in CBC panel
timeFrame: After 14 days of supplementation
measure: Changes in interleukin-6
timeFrame: After 14 days of supplementation
measure: Changes in interleukin-1B
timeFrame: After 14 days of supplementation
measure: Changes in interleukin-10
timeFrame: After 14 days of supplementation
measure: Changes in T cell
timeFrame: After 14 days of supplementation
measure: Changes in B cell
timeFrame: After 14 days of supplementation
Secondary outcomes:
measure: Safety Outcome Measures
timeFrame: After 14 days of supplementation
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of South Carolina Sport Science Lab
state: South Carolina
Study officials:
affiliation: Principal Investigator
name: Bridget McFadden
role: PRINCIPAL_INVESTIGATOR
References: