Effects of Immulina on Natural Killer Cells
Conditions
Keywords
Immulina, Natural Killer Cells (NK), Dietary supplementation
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTImmulina Dietary Supplementation
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.
Sponsors
University of Mississippi Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Natural Killer (NK) cell count | 4 weeks | Differences in NK cell counts from baseline to 4 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Natural Killer (NK) cell cytotoxic activity | 4 weeks | Differences in NK cell cytotoxic activity from baseline to 4 weeks |
| Cytokine profiles | 4 weeks | 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) |
| Immune cell populations | 4 weeks | Differences in immune cell populations in PBMC from baseline to 4 weeks. |
Countries
United States
Outcome results
None listed