Effects of Immulina on Natural Killer Cells Clinical Trial
Official title:
Effects of Immulina Dietary Supplementation on Innate and Adaptive Immune Measures in Normal Human Volunteers
| Verified date | May 2022 |
| Source | University of Mississippi Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | March 11, 2021 |
| Est. primary completion date | February 28, 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 64 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Mississippi Medical Center | Jackson | Mississippi |
| Lead Sponsor | Collaborator |
|---|---|
| University of Mississippi Medical Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Natural Killer (NK) cell count | Differences in NK cell counts from baseline to 4 weeks | 4 weeks | |
| Secondary | Natural Killer (NK) cell cytotoxic activity | Differences in NK cell cytotoxic activity from baseline to 4 weeks | 4 weeks | |
| Secondary | Cytokine profiles | Differences in in-Vitro peripheral blood mononuclear cell (PBMC) culture supernatants' cytokine profiles from baseline to 4 weeks (IFN-a, IFN-?, IL-1ß, IL-2, IL-4, IL-6, Il-10, IL-12, Il-15 and TNFa) | 4 weeks | |
| Secondary | Immune cell populations | Differences in immune cell populations in PBMC from baseline to 4 weeks. | 4 weeks |