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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
492
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.
Placebo is inert powder in cellulose capsule that appears identical to Immulina TM capsules.
University of Mississippi Medical Center
Jackson, Mississippi, United States
Natural Killer cell (NK)-mediated cytotoxicity
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
Natural Killer (NK) cell count
Differences in NK cell counts from baseline to 20 weeks
Time frame: 20 weeks
Cytotoxic T lymphocyte (CTL) number
Differences in CTL counts from baseline to 20 weeks
Time frame: 20 weeks
Plasma cytokine profile; IL1b, IL6, TNF alpha, IL2, IL7, IL12, IL15 and IL18; pg/mL
Differences in plasma cytokine profiles from baseline to 20 weeks
Time frame: 20 weeks
Immunophenotyping panel biomarkers- CD3, CD4, CD8, CD25, FoxP3, IL10, Interferon gamma, IL4, TGF beta counts
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
Influenza A IgG antibody, U/mL
Differences in Influenza A IgG antibody U/mL from baseline to 20 weeks
Time frame: 20 weeks
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Influenza B IgG antibody, U/mL
Differences in Influenza B IgG antibody U/mL from baseline to 20 weeks
Time frame: 20 weeks
serum Interferon gamma, pg/mL
Differences in Interferon gamma levels from baseline to 20 weeks
Time frame: 20 weeks
serum Interferon alpha, pg/mL
Differences in Interferon alpha levels from baseline to 20 weeks
Time frame: 20 weeks