Spirulina Oral Supplement for Enhancing Host Resilience to Virus Infection

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Dietary Supplement: Immulina TM
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 18-59 (study group 1) or ages 65 and above (study group 2) Any chronic illness must be determined (by PI team) to be stable as evidenced by no changes in medical regimens within 30 days of enrollment. Ability to comprehend the specific activities required to participate in the trial for which the participant is to be enrolled. Exclusion Criteria: Any acute illness or significant injury within 30 days of enrollment. Specific disease entities, which, in the opinion of the PI, could reasonably be assumed to have dysfunctional immune function as a component of their illness. These include HIV, AIDS, uncontrolled asthma, uncontrolled eczema, uncontrolled allergic rhinitis, uncontrolled urticaria, Rheumatoid arthritis, lupus, inflammatory bowel disease, multiple sclerosis, Type-1 diabetes mellitus, Guillain-Barr syndrome, Grave's disease, Hashimoto's thyroiditis, myasthenia gravis or vasculitis. Active autoimmune diseases regardless of clinical stability. A history of autoimmune disease that is not considered active (i.e. no medical therapy for at least 1 year prior to enrollment) will not be excluded. History of unstable chronic illness within 30 days of enrollment. Unable/unwilling to commit to multiple research clinic visits which will be described in detail.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>inert capsules; 2 capsules given by mouth in the morning and 2 capsules given by mouth in the evening for 16 weeks duration. | Dietary Supplement: Placebo<br>* Placebo is inert powder in cellulose capsule that appears identical to Immulina TM capsules.<br>|
| Experimental: Immulina TM 200 mg/day<br>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. | Dietary Supplement: Immulina TM<br>* 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.<br>* Other names: Spirulina;|
| Experimental: Immulina TM 400 mg/day<br>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. | Dietary Supplement: Immulina TM<br>* 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.<br>* Other names: Spirulina;|
| Experimental: Immulina TM 800 mg/day<br>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. | Dietary Supplement: Immulina TM<br>* 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.<br>* Other names: Spirulina;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza, Immulina TM, Natural Killer Cells (NK), Botanical Dietary Supplement, Dietary Supplementation