Effects of Immulina on Immune Measures
- Conditions
- Effects of Immulina on Natural Killer Cells
- Interventions
- Dietary Supplement: Immulina Dietary Supplementation
- Registration Number
- NCT04071730
- Lead Sponsor
- University of Mississippi Medical Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Immulina Dietary Supplementation Immulina Dietary Supplementation 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 Immulina Dietary Supplementation Placebo - inert capsules; 2 capsules given by mouth in the morning and 2 capsules given by mouth in the evening for 4 weeks duration
- Primary Outcome Measures
Name Time Method Natural Killer (NK) cell count 4 weeks Differences in NK cell counts from baseline to 4 weeks
- Secondary Outcome Measures
Name Time Method Natural Killer (NK) cell cytotoxic activity 4 weeks Differences in NK cell cytotoxic activity from baseline to 4 weeks
Immune cell populations 4 weeks Differences in immune cell populations in PBMC 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)
Trial Locations
- Locations (1)
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States