Effects of Immulina on Immune Measures

University of Mississippi

Status: Completed

Conditions: Effects of Immulina on Natural Killer Cells

Treatments: Dietary Supplement: Immulina Dietary Supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT04071730

2019-0183

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Immulina Dietary Supplementation

Experimental group

Description:

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

Treatment:

Dietary Supplement: Immulina Dietary Supplementation

Placebo

Placebo Comparator group

Description:

Placebo - inert capsules; 2 capsules given by mouth in the morning and 2 capsules given by mouth in the evening for 4 weeks duration

Treatment:

Dietary Supplement: Immulina Dietary Supplementation