Inflammatory and Immune Response After High Intensity Exercise

NCT05277727 | Completed

• 1 other identifier: M01-21-01-T0011
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Response

Outcome Measures

Primary Outcomes (6)

• 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

Secondary Outcomes (1)

• Safety Outcome Measures

  After 14 days of supplementation

Study Arms (2)

Fucoidan

EXPERIMENTAL

Fucoidan in Capsule Intervention: Dietary Supplement: Probiotic

Dietary Supplement: Fucoidan 500mg

Placebo

PLACEBO COMPARATOR

Non active ingredients in a capsule Intervention: Other: Placebo

Dietary Supplement: Placebo

Interventions

Fucoidan 500mg DIETARY_SUPPLEMENT

1 capsule to be taken twice daily with food (morning and evening).

Fucoidan

Placebo DIETARY_SUPPLEMENT

1 capsule to be taken twice daily with food (morning and evening).

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marinova Pty Ltd: lead
• Nutrasource Pharmaceutical and Nutraceutical Services, Inc.: collaborator
• University of South Carolina: collaborator

Study Sites (1)

University of South Carolina Sport Science Lab

Columbia, South Carolina, 29208, United States

Location

MeSH Terms

Interventions

fucoidan

Study Officials

• Bridget McFadden

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both subjects and study research team will not be aware of their assigned conditions.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 14, 2022
• Study Start: January 5, 2022
• Primary Completion: March 4, 2022
• Study Completion: June 30, 2022
• Last Updated: July 12, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)