Status:
COMPLETED
Effects of Immulina on Immune Measures
Lead Sponsor:
University of Mississippi Medical Center
Conditions:
Effects of Immulina on Natural Killer Cells
Eligibility:
All Genders
18-64 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 11 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04071730
Start Date
September 3 2019
End Date
March 11 2021
Last Update
May 19 2022
Active Locations (1)
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1
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216