Clinical trial NCT04071730: Effects of Immulina on Immune Measures
Official title: Effects of Immulina Dietary Supplementation on Innate and Adaptive Immune Measures in Normal Human Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effects of Immulina on Natural Killer Cells
Keywords: Immulina
Natural Killer Cells (NK)
Dietary supplementation
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Natural Killer (NK) cell count
timeFrame: 4 weeks
Secondary outcomes:
measure: Natural Killer (NK) cell cytotoxic activity
timeFrame: 4 weeks
measure: Cytokine profiles
timeFrame: 4 weeks
measure: Immune cell populations
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: Study Principal Investigator
name: Gailen D Marshall, Jr., MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: