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This small, randomized, double blind, placebo controlled pilot study is aimed at determining the effects of oral Immulina dietary supplementation on specific immune biomarkers in the blood.
This small, randomized, double blind, placebo controlled pilot study is aimed at determining the effects of four weeks of daily Immulina dietary supplementation (800 mg/day) versus four weeks of daily placebo on natural killer (NK) cell numbers and/or natural killer (NK) cell activity in human peripheral blood mononuclear cells collected from human research participants who meet the trial's inclusion/exclusion criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immulina Dietary Supplementation | Experimental | Immulina Dietary Supplementation - 200 mg capsules; 800 mg/day; 2 (200 mg) capsules given by mouth in the morning and 2 (200 mg) capsules given by mouth in the evening for 4 weeks duration |
|
| Placebo | Placebo Comparator | Placebo - inert capsules; 2 capsules given by mouth in the morning and 2 capsules given by mouth in the evening for 4 weeks duration |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immulina Dietary Supplementation | Dietary Supplement | Immulina Dietary Supplementation 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 (NK) cell count | Differences in NK cell counts from baseline to 4 weeks | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Natural Killer (NK) cell cytotoxic activity | Differences in NK cell cytotoxic activity from baseline to 4 weeks | 4 weeks |
| Cytokine profiles | Differences in in-Vitro peripheral blood mononuclear cell (PBMC) culture supernatants' cytokine profiles from baseline to 4 weeks (IFN-α, IFN-γ, IL-1β, IL-2, IL-4, IL-6, Il-10, IL-12, Il-15 and TNFα) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gailen D Marshall, Jr., MD, PhD | Study Principal Investigator | 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 |
|---|---|
| C459207 | Immulina |
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|
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| 4 weeks |
| Immune cell populations | Differences in immune cell populations in PBMC from baseline to 4 weeks. | 4 weeks |