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| ID | Type | Description | Link |
|---|---|---|---|
| 1U19AT010838-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | inert capsules; 2 capsules given by mouth in the morning and 2 capsules given by mouth in the evening for 16 weeks duration. |
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| Immulina TM 200 mg/day | Experimental | Immulina Dietary supplementation (200 mg per capsule); 1-200 mg capsule and 1 placebo capsule given by mouth in the morning and 2 placebo capsules given by mouth in the evening for 16 weeks duration. |
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| Immulina TM 400 mg/day | Experimental | Immulina Dietary supplementation (200 mg per capsule); 1-200 mg capsule and 1 placebo capsule given by mouth in the morning and 1-200 mg capsule and 1 placebo capsule given by mouth in the evening for 16 weeks duration. |
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| Immulina TM 800 mg/day | Experimental | Immulina Dietary supplementation (200 mg per capsule); 2-200 mg capsules given by mouth in the morning and 2-200 mg capsules given by mouth in the evening for 16 weeks duration. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immulina TM | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Natural Killer (NK) cell count | Differences in NK cell counts from baseline to 20 weeks | 20 weeks |
| Cytotoxic T lymphocyte (CTL) number | Differences in CTL counts from baseline to 20 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gailen D Marshall Jr., MD, PhD | University of Mississippi Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| Placebo | Dietary Supplement | Placebo is inert powder in cellulose capsule that appears identical to Immulina TM capsules. |
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| 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 | 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 | 20 weeks |
| Influenza A IgG antibody, U/mL | Differences in Influenza A IgG antibody U/mL from baseline to 20 weeks | 20 weeks |
| Influenza B IgG antibody, U/mL | Differences in Influenza B IgG antibody U/mL from baseline to 20 weeks | 20 weeks |
| serum Interferon gamma, pg/mL | Differences in Interferon gamma levels from baseline to 20 weeks | 20 weeks |
| serum Interferon alpha, pg/mL | Differences in Interferon alpha levels from baseline to 20 weeks | 20 weeks |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |