Effects of Immulina Dietary Supplementation on Innate and Adaptive Immune Measures in Normal Human Volunteers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Natural Killer (NK) cell count
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts 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/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
Arms & Interventions
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
Intervention: Immulina Dietary Supplementation (Dietary Supplement)
Placebo
Placebo - inert capsules; 2 capsules given by mouth in the morning and 2 capsules given by mouth in the evening for 4 weeks duration
Intervention: Immulina Dietary Supplementation (Dietary Supplement)
Outcomes
Primary Outcomes
Natural Killer (NK) cell count
Time Frame: 4 weeks
Differences in NK cell counts from baseline to 4 weeks
Secondary Outcomes
- Immune cell populations(4 weeks)
- Natural Killer (NK) cell cytotoxic activity(4 weeks)
- Cytokine profiles(4 weeks)
Investigators
Gailen D. Marshall Jr., MD PhD
The R. Faser Triplett, Sr., MD Chair of Allergy and Immunology, Professor of Medicine, Pediatrics, Pathology and Population Science
University of Mississippi Medical Center