Effects of Immulina on Immune Measures

Not Applicable

Completed

• Conditions: Effects of Immulina on Natural Killer Cells

• 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.

Study Timeline

• Study First Submitted: 2019-08-26
• Study First Submitted QC: 2019-08-26
• Study First Posted: 2019-08-28
• Study Start: 2019-09-03
• Primary Completion: 2021-02-28
• Study Completion: 2021-03-11
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-18
• Last Update Posted: 2022-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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