University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
NCT Number: NCT05447078
This randomized, double blind, placebo controlled study aims to establish the impact of the oral supplement, Immulina TM, on enhancing host resilience to the effects of viral influenza infection in humans.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Jackson, Mississippi, 39216, United States
This randomized, double blind, placebo controlled study aims to establish the impact of the oral supplement, Immulina TM, on increasing host resilience against the pathogenic effects of influenza virus infection in normal and immune compromised individuals by measuring a biomarker profile designed to reflect immune components associated with antiviral natural killer cell numbers and activity, cytotoxic T cell numbers, vaccine-related flu-specific antibody responses and cytokine profiles associated with host antiviral innate and adaptive immune responses.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Immulina TM is a highly standardized extract derived from various preparations of Spirulina, a cyanobacterium, marketed as a dietary supplement and has been utilized in several clinical studies describing its immunopotentiating properties.
Other names: Spirulina
Placebo is inert powder in cellulose capsule that appears identical to Immulina TM capsules.
Time frame: 20 weeks
NK cell-mediated cytotoxicity is characterized by cytolysis of a CFSE-labeled target cell (K562) by effector cells (NK cells). Labeled K562 are cultured with NK cells for a period of time, then all cells labeled with a live-dead stain, 7-AAD. The cytolytic activity is expressed as the percent dead K562.
Differences in cytolytic activity (% dead K562) from baseline to 20 weeks.
Time frame: 20 weeks
Differences in NK cell counts from baseline to 20 weeks
Time frame: 20 weeks
Differences in CTL counts from baseline to 20 weeks
Time frame: 20 weeks
Differences in plasma cytokine profiles from baseline to 20 weeks
Time frame: 20 weeks
CD3 (mature T cells), CD4(T helper/inducer cell), CD8 (T suppressor/cytotoxic cell), CD25 (IL2 suppressor), FoxP3 (T regulator cell), IL10 (T regulatory suppressor cell), Interferon gamma (T helper 1 cell), IL4 (T helper 2 cell) and TGF beta (T regulatory suppressor cell) counts in human peripheral blood mononuclear cells measured by flow cytometry.
Differences in Immunophenotyping panel biomarker counts from baseline to 20 weeks
Time frame: 20 weeks
Differences in Influenza A IgG antibody U/mL from baseline to 20 weeks
Time frame: 20 weeks
Differences in Influenza B IgG antibody U/mL from baseline to 20 weeks
Time frame: 20 weeks
Differences in Interferon gamma levels from baseline to 20 weeks
Time frame: 20 weeks
Differences in Interferon alpha levels from baseline to 20 weeks
University of Mississippi Medical Center
Other
Impact of Oral Immulina TM on Natural Killer Cell Activities and Other Biomarkers Associated With Increasing Host Immune Resilience to Upper Respiratory Viruses in Normal Human Volunteers
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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