Effects of Immulina on Immune Measures

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Immulina Dietary Supplementation on Innate and Adaptive Immune Measures in Normal Human Volunteers

Conditions
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Effects of Immulina on Natural Killer Cells

Intervention / Treatment
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* Dietary Supplement: Immulina Dietary Supplementation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Normal, generally healthy adults between ages 18-64 and who may or may not have a controlled disease(s). Examples of controlled diseases are controlled Type-2 diabetes mellitus, controlled hypertension, controlled allergic rhinitis, etc. Exclusion Criteria: Individuals with specific disease entities, which, in the opinion of the Principal Investigator, 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-Barre syndrome, psoriasis, Grave's disease, Hashimoto's thyroiditis, myasthenia gravis or vasculitis. Individuals taking specific dietary supplements including probiotic, microalgae or beta glucan containing dietary supplements, fermented food products (such as yogurt, bean curd, etc.). If the potential participants reports usage of any of these products, they will be asked if they would be willing to withhold products for 30 days and then be re-screened for inclusion/exclusion criteria. Individuals who are unwilling to refrain for the duration of the trial from taking the specific dietary supplements and fermented food products including probiotic, microalgae or beta glucan containing dietary supplements, fermented food products (such as yogurt, bean curd, etc.). Pregnant females (because baseline immune responses, are altered by pregnancy) Individuals unable to speak, understand and read English

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 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 |
| --- | --- |
| Experimental: Immulina Dietary Supplementation<br>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 | Dietary Supplement: Immulina Dietary Supplementation<br>* 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.<br>* Other names: Spirulina;|
| Placebo Comparator: Placebo<br>Placebo - inert capsules; 2 capsules given by mouth in the morning and 2 capsules given by mouth in the evening for 4 weeks duration | Dietary Supplement: Immulina Dietary Supplementation<br>* 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.<br>* Other names: Spirulina;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Natural Killer (NK) cell count | Differences in NK cell counts from baseline to 4 weeks | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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) | 4 weeks | 
| Immune cell populations | Differences in immune cell populations in PBMC from baseline to 4 weeks. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immulina, Natural Killer Cells (NK), Dietary supplementation